Heidi Splete

Patients with RA who initiated abatacept had significantly lower risk of hospitalized infection, compared with those who initiated a tumor necrosis factor inhibitor (TNFi), based on data from more than 11,000 matched pairs of patients.

“Given similar efficacy between abatacept and TNFi as biologic therapies for treatment of RA, one of the main determinants in choosing between the medications is minimizing the risk of infection,” wrote Sarah K. Chen, MD, of Brigham and Women’s Hospital in Boston, and her colleagues.

In a study published in Arthritis Care & Research, the researchers identified 11,248 propensity score–matched pairs of RA patients aged 18 years and older with at least two RA diagnoses who initiated abatacept or a TNFi. The average age of the patients was 56 years; 83% were women. The primary outcome was hospitalized infection. Patients with conditions that might increase the risk of infection, such as malignancy, HIV/AIDS, renal dialysis, or a history of bone marrow transplant were excluded, as were patients who had used rituximab, tocilizumab, or tofacitinib before the start of the study.

Overall, the incidence rate for a hospitalized infection was 37 per 1,000 person-years among abatacept patients and 47 per 1,000 person-years among TNFi patients (hazard ratio, 0.78). In a subgroup analysis, the difference in infection rate remained significant between abatacept and infliximab (HR, 0.63), and no significant difference occurred between abatacept and etanercept.

The researchers also examined secondary outcomes including bacterial infection, herpes zoster, and infections of various organs. The risk of these was similar between abatacept and TNF inhibitors for all but pulmonary infections, which was lower for abatacept.

The study was supported by an investigator-sponsored research grant from Bristol-Myers Squibb. Dr. Chen had no financial conflicts to disclose.

SOURCE: Chen SK et al. Arthritis Care Res. 2018 Dec 20. doi: 10.1002/acr.23824.

Patients with RA who initiated abatacept had significantly lower risk of hospitalized infection, compared with those who initiated a tumor necrosis factor inhibitor (TNFi), based on data from more than 11,000 matched pairs of patients.

“Given similar efficacy between abatacept and TNFi as biologic therapies for treatment of RA, one of the main determinants in choosing between the medications is minimizing the risk of infection,” wrote Sarah K. Chen, MD, of Brigham and Women’s Hospital in Boston, and her colleagues.

In a study published in Arthritis Care & Research, the researchers identified 11,248 propensity score–matched pairs of RA patients aged 18 years and older with at least two RA diagnoses who initiated abatacept or a TNFi. The average age of the patients was 56 years; 83% were women. The primary outcome was hospitalized infection. Patients with conditions that might increase the risk of infection, such as malignancy, HIV/AIDS, renal dialysis, or a history of bone marrow transplant were excluded, as were patients who had used rituximab, tocilizumab, or tofacitinib before the start of the study.

Overall, the incidence rate for a hospitalized infection was 37 per 1,000 person-years among abatacept patients and 47 per 1,000 person-years among TNFi patients (hazard ratio, 0.78). In a subgroup analysis, the difference in infection rate remained significant between abatacept and infliximab (HR, 0.63), and no significant difference occurred between abatacept and etanercept.

The researchers also examined secondary outcomes including bacterial infection, herpes zoster, and infections of various organs. The risk of these was similar between abatacept and TNF inhibitors for all but pulmonary infections, which was lower for abatacept.

The study was supported by an investigator-sponsored research grant from Bristol-Myers Squibb. Dr. Chen had no financial conflicts to disclose.

SOURCE: Chen SK et al. Arthritis Care Res. 2018 Dec 20. doi: 10.1002/acr.23824.

Patients with RA who initiated abatacept had significantly lower risk of hospitalized infection, compared with those who initiated a tumor necrosis factor inhibitor (TNFi), based on data from more than 11,000 matched pairs of patients.

“Given similar efficacy between abatacept and TNFi as biologic therapies for treatment of RA, one of the main determinants in choosing between the medications is minimizing the risk of infection,” wrote Sarah K. Chen, MD, of Brigham and Women’s Hospital in Boston, and her colleagues.

In a study published in Arthritis Care & Research, the researchers identified 11,248 propensity score–matched pairs of RA patients aged 18 years and older with at least two RA diagnoses who initiated abatacept or a TNFi. The average age of the patients was 56 years; 83% were women. The primary outcome was hospitalized infection. Patients with conditions that might increase the risk of infection, such as malignancy, HIV/AIDS, renal dialysis, or a history of bone marrow transplant were excluded, as were patients who had used rituximab, tocilizumab, or tofacitinib before the start of the study.

Overall, the incidence rate for a hospitalized infection was 37 per 1,000 person-years among abatacept patients and 47 per 1,000 person-years among TNFi patients (hazard ratio, 0.78). In a subgroup analysis, the difference in infection rate remained significant between abatacept and infliximab (HR, 0.63), and no significant difference occurred between abatacept and etanercept.

The researchers also examined secondary outcomes including bacterial infection, herpes zoster, and infections of various organs. The risk of these was similar between abatacept and TNF inhibitors for all but pulmonary infections, which was lower for abatacept.

The study was supported by an investigator-sponsored research grant from Bristol-Myers Squibb. Dr. Chen had no financial conflicts to disclose.

SOURCE: Chen SK et al. Arthritis Care Res. 2018 Dec 20. doi: 10.1002/acr.23824.

Tofacitinib significantly improved skin lesions associated with cutaneous sarcoidosis, according to a case report published in the New England Journal of Medicine.

Treatment options for cutaneous sarcoidosis are limited, as are data on the effectiveness of alternatives to prednisone, which is often the first choice despite adverse effects, wrote William Damsky, MD, of Yale University in New Haven, Conn., and his colleagues.

Previous studies have suggested involvement of the JAK-STAT pathway in sarcoidosis; therefore, the researchers treated a patient who had refractory cutaneous sarcoidosis with oral tofacitinib. The treatment significantly improved the patient’s skin lesions both clinically and histologically.

The patient was a 48-year-old woman with a history of cutaneous and pulmonary sarcoidosis and treatment-resistant skin lesions. At the time of the case report, she had no pulmonary symptoms and no ophthalmologic issues, but presented with pink-brown indurated papules and plaques, and some alopecia on her scalp (N Engl J Med. 2018;379:2540-6).

The patient had not responded to other medications including glucocorticoids, minocycline, hydroxychloroquine, methotrexate, adalimumab, tacrolimus, and apremilast. With her consent, the patient received off-label tofacitinib at 5 mg twice daily. The lesions began to improve, but treatment was discontinued because of insurance issues. When treatment resumed, the patient’s Cutaneous Sarcoidosis Activity and Morphology Instrument (CSAMI) score, used to assess disease activity, was 85 on a scale of 0 to 165; this score dropped to 53 after 4 months of treatment.

In addition, two samples collected after 10 months of treatment showed histologic resolution of granulomas.

Although the findings must be replicated in other patients, the results suggest that “the dysregulation of JAK-STAT–dependent cytokines (e.g., interferon-gamma) is pathogenically involved in cutaneous sarcoidosis and, probably, in sarcoidosis in general,” the researchers said.

Dr. Damsky disclosed a financial relationship with Eli Lilly, and research funding from the Dermatology Foundation and the National Institutes of Health. The study was supported by the Ranjini and Ajay Poddar Resource Fund for Dermatologic Diseases Research, the National Institutes of Health, and the Dermatology Foundation.
 

SOURCE: Damsky W et al. N Engl J Med. 2018;379:2540-6.

Tofacitinib significantly improved skin lesions associated with cutaneous sarcoidosis, according to a case report published in the New England Journal of Medicine.

Treatment options for cutaneous sarcoidosis are limited, as are data on the effectiveness of alternatives to prednisone, which is often the first choice despite adverse effects, wrote William Damsky, MD, of Yale University in New Haven, Conn., and his colleagues.

Previous studies have suggested involvement of the JAK-STAT pathway in sarcoidosis; therefore, the researchers treated a patient who had refractory cutaneous sarcoidosis with oral tofacitinib. The treatment significantly improved the patient’s skin lesions both clinically and histologically.

The patient was a 48-year-old woman with a history of cutaneous and pulmonary sarcoidosis and treatment-resistant skin lesions. At the time of the case report, she had no pulmonary symptoms and no ophthalmologic issues, but presented with pink-brown indurated papules and plaques, and some alopecia on her scalp (N Engl J Med. 2018;379:2540-6).

The patient had not responded to other medications including glucocorticoids, minocycline, hydroxychloroquine, methotrexate, adalimumab, tacrolimus, and apremilast. With her consent, the patient received off-label tofacitinib at 5 mg twice daily. The lesions began to improve, but treatment was discontinued because of insurance issues. When treatment resumed, the patient’s Cutaneous Sarcoidosis Activity and Morphology Instrument (CSAMI) score, used to assess disease activity, was 85 on a scale of 0 to 165; this score dropped to 53 after 4 months of treatment.

In addition, two samples collected after 10 months of treatment showed histologic resolution of granulomas.

Although the findings must be replicated in other patients, the results suggest that “the dysregulation of JAK-STAT–dependent cytokines (e.g., interferon-gamma) is pathogenically involved in cutaneous sarcoidosis and, probably, in sarcoidosis in general,” the researchers said.

Dr. Damsky disclosed a financial relationship with Eli Lilly, and research funding from the Dermatology Foundation and the National Institutes of Health. The study was supported by the Ranjini and Ajay Poddar Resource Fund for Dermatologic Diseases Research, the National Institutes of Health, and the Dermatology Foundation.
 

SOURCE: Damsky W et al. N Engl J Med. 2018;379:2540-6.

Tofacitinib significantly improved skin lesions associated with cutaneous sarcoidosis, according to a case report published in the New England Journal of Medicine.

Treatment options for cutaneous sarcoidosis are limited, as are data on the effectiveness of alternatives to prednisone, which is often the first choice despite adverse effects, wrote William Damsky, MD, of Yale University in New Haven, Conn., and his colleagues.

Previous studies have suggested involvement of the JAK-STAT pathway in sarcoidosis; therefore, the researchers treated a patient who had refractory cutaneous sarcoidosis with oral tofacitinib. The treatment significantly improved the patient’s skin lesions both clinically and histologically.

The patient was a 48-year-old woman with a history of cutaneous and pulmonary sarcoidosis and treatment-resistant skin lesions. At the time of the case report, she had no pulmonary symptoms and no ophthalmologic issues, but presented with pink-brown indurated papules and plaques, and some alopecia on her scalp (N Engl J Med. 2018;379:2540-6).

The patient had not responded to other medications including glucocorticoids, minocycline, hydroxychloroquine, methotrexate, adalimumab, tacrolimus, and apremilast. With her consent, the patient received off-label tofacitinib at 5 mg twice daily. The lesions began to improve, but treatment was discontinued because of insurance issues. When treatment resumed, the patient’s Cutaneous Sarcoidosis Activity and Morphology Instrument (CSAMI) score, used to assess disease activity, was 85 on a scale of 0 to 165; this score dropped to 53 after 4 months of treatment.

In addition, two samples collected after 10 months of treatment showed histologic resolution of granulomas.

Although the findings must be replicated in other patients, the results suggest that “the dysregulation of JAK-STAT–dependent cytokines (e.g., interferon-gamma) is pathogenically involved in cutaneous sarcoidosis and, probably, in sarcoidosis in general,” the researchers said.

Dr. Damsky disclosed a financial relationship with Eli Lilly, and research funding from the Dermatology Foundation and the National Institutes of Health. The study was supported by the Ranjini and Ajay Poddar Resource Fund for Dermatologic Diseases Research, the National Institutes of Health, and the Dermatology Foundation.
 

SOURCE: Damsky W et al. N Engl J Med. 2018;379:2540-6.

U.S. Surgeon General Jerome Adams, MD, responded Dec. 18 to recent data showing a sharp increase in the use of nicotine-based e-cigarette products among American teens with an urgent call to action.

“I, Surgeon General of the United States Public Health Service, [Vice Admiral] Jerome Adams, am emphasizing the importance of protecting our children from a lifetime of nicotine addiction and associated health risks by immediately addressing the epidemic of youth e-cigarette use,” Dr. Adams said in an advisory. “The recent surge in e-cigarette use among youth, which has been fueled by new types of e-cigarettes that have recently entered the market, is a cause for great concern. We must take action now to protect the health of our nation’s young people.”

The surgeon general’s advisory emphasized that e-cigarette products are not harmless and that, in addition to potentially addictive nicotine, many products contain other dangerous substances, including heavy metals, volatile organic compounds, and ultrafine particles that can affect the lungs. In addition, some e-cigarette products contain potentially harmful chemicals used to add flavoring.

The complete advisory includes information for parents, teachers, and clinicians about the details of current e-cigarette products and strategies for working to reduce their use among teens.

The American Medical Association expressed support of the surgeon general’s call to action.

“The only way to prevent another generation from developing nicotine dependence is to continue to raise awareness that e-cigarettes are harmful, powerfully addictive, and can often lead young people to smoke conventional cigarettes. E-cigarettes have the potential to undermine the public health gains that have been made over the years in combating the smoking epidemic,” Barbara L. McAneny, MD, president of the AMA, said in the statement.

“Recognizing the use of e-cigarettes and vaping as an urgent public health epidemic, the AMA has adopted numerous policies in recent years aimed at preventing youth access to these harmful tobacco products. In line with the surgeon general’s advisory, the AMA also has existing policy urging physicians to educate themselves about e-cigarettes and be prepared to counsel patients about e-cigarette usage and the potential for nicotine addiction,” Dr. McAneny said. The AMA is working with the Food and Drug Administration to curb the marketing of e-cigarettes and other vaping products to individuals younger than 21 years, she added.

The American Heart Association expressed support for the surgeon general’s call as well.

“That the U.S. Surgeon General is calling teen vaping an ‘epidemic’ should seize the attention of elected officials and the community of organizations working to protect the health of our nation’s children. We commend Surgeon General Adams, Commissioner [Adam] Gottlieb and Secretary [Alex M.] Azar for marshaling parents, educators, health providers, and communities to apply proven methods to overcome the epidemic of e-cigarette use,” Nancy Brown, CEO of the AHA, said in a Dec. 18 statement.

“But more must be done in the face of rapidly rising e-cigarette use among youth. The FDA’s recent announcement that it plans to restrict marketing and sales of flavored tobacco products must be followed by immediate, concrete action that sends an unmistakable message that the tobacco industry’s relentless targeting of our nation’s children will no longer be tolerated,” she emphasized.

View the surgeon general’s video message and access additional e-cigarette information here.

U.S. Surgeon General Jerome Adams, MD, responded Dec. 18 to recent data showing a sharp increase in the use of nicotine-based e-cigarette products among American teens with an urgent call to action.

“I, Surgeon General of the United States Public Health Service, [Vice Admiral] Jerome Adams, am emphasizing the importance of protecting our children from a lifetime of nicotine addiction and associated health risks by immediately addressing the epidemic of youth e-cigarette use,” Dr. Adams said in an advisory. “The recent surge in e-cigarette use among youth, which has been fueled by new types of e-cigarettes that have recently entered the market, is a cause for great concern. We must take action now to protect the health of our nation’s young people.”

The surgeon general’s advisory emphasized that e-cigarette products are not harmless and that, in addition to potentially addictive nicotine, many products contain other dangerous substances, including heavy metals, volatile organic compounds, and ultrafine particles that can affect the lungs. In addition, some e-cigarette products contain potentially harmful chemicals used to add flavoring.

The complete advisory includes information for parents, teachers, and clinicians about the details of current e-cigarette products and strategies for working to reduce their use among teens.

The American Medical Association expressed support of the surgeon general’s call to action.

“The only way to prevent another generation from developing nicotine dependence is to continue to raise awareness that e-cigarettes are harmful, powerfully addictive, and can often lead young people to smoke conventional cigarettes. E-cigarettes have the potential to undermine the public health gains that have been made over the years in combating the smoking epidemic,” Barbara L. McAneny, MD, president of the AMA, said in the statement.

“Recognizing the use of e-cigarettes and vaping as an urgent public health epidemic, the AMA has adopted numerous policies in recent years aimed at preventing youth access to these harmful tobacco products. In line with the surgeon general’s advisory, the AMA also has existing policy urging physicians to educate themselves about e-cigarettes and be prepared to counsel patients about e-cigarette usage and the potential for nicotine addiction,” Dr. McAneny said. The AMA is working with the Food and Drug Administration to curb the marketing of e-cigarettes and other vaping products to individuals younger than 21 years, she added.

The American Heart Association expressed support for the surgeon general’s call as well.

“That the U.S. Surgeon General is calling teen vaping an ‘epidemic’ should seize the attention of elected officials and the community of organizations working to protect the health of our nation’s children. We commend Surgeon General Adams, Commissioner [Adam] Gottlieb and Secretary [Alex M.] Azar for marshaling parents, educators, health providers, and communities to apply proven methods to overcome the epidemic of e-cigarette use,” Nancy Brown, CEO of the AHA, said in a Dec. 18 statement.

“But more must be done in the face of rapidly rising e-cigarette use among youth. The FDA’s recent announcement that it plans to restrict marketing and sales of flavored tobacco products must be followed by immediate, concrete action that sends an unmistakable message that the tobacco industry’s relentless targeting of our nation’s children will no longer be tolerated,” she emphasized.

View the surgeon general’s video message and access additional e-cigarette information here.

U.S. Surgeon General Jerome Adams, MD, responded Dec. 18 to recent data showing a sharp increase in the use of nicotine-based e-cigarette products among American teens with an urgent call to action.

“I, Surgeon General of the United States Public Health Service, [Vice Admiral] Jerome Adams, am emphasizing the importance of protecting our children from a lifetime of nicotine addiction and associated health risks by immediately addressing the epidemic of youth e-cigarette use,” Dr. Adams said in an advisory. “The recent surge in e-cigarette use among youth, which has been fueled by new types of e-cigarettes that have recently entered the market, is a cause for great concern. We must take action now to protect the health of our nation’s young people.”

The surgeon general’s advisory emphasized that e-cigarette products are not harmless and that, in addition to potentially addictive nicotine, many products contain other dangerous substances, including heavy metals, volatile organic compounds, and ultrafine particles that can affect the lungs. In addition, some e-cigarette products contain potentially harmful chemicals used to add flavoring.

The complete advisory includes information for parents, teachers, and clinicians about the details of current e-cigarette products and strategies for working to reduce their use among teens.

The American Medical Association expressed support of the surgeon general’s call to action.

“The only way to prevent another generation from developing nicotine dependence is to continue to raise awareness that e-cigarettes are harmful, powerfully addictive, and can often lead young people to smoke conventional cigarettes. E-cigarettes have the potential to undermine the public health gains that have been made over the years in combating the smoking epidemic,” Barbara L. McAneny, MD, president of the AMA, said in the statement.

“Recognizing the use of e-cigarettes and vaping as an urgent public health epidemic, the AMA has adopted numerous policies in recent years aimed at preventing youth access to these harmful tobacco products. In line with the surgeon general’s advisory, the AMA also has existing policy urging physicians to educate themselves about e-cigarettes and be prepared to counsel patients about e-cigarette usage and the potential for nicotine addiction,” Dr. McAneny said. The AMA is working with the Food and Drug Administration to curb the marketing of e-cigarettes and other vaping products to individuals younger than 21 years, she added.

The American Heart Association expressed support for the surgeon general’s call as well.

“That the U.S. Surgeon General is calling teen vaping an ‘epidemic’ should seize the attention of elected officials and the community of organizations working to protect the health of our nation’s children. We commend Surgeon General Adams, Commissioner [Adam] Gottlieb and Secretary [Alex M.] Azar for marshaling parents, educators, health providers, and communities to apply proven methods to overcome the epidemic of e-cigarette use,” Nancy Brown, CEO of the AHA, said in a Dec. 18 statement.

“But more must be done in the face of rapidly rising e-cigarette use among youth. The FDA’s recent announcement that it plans to restrict marketing and sales of flavored tobacco products must be followed by immediate, concrete action that sends an unmistakable message that the tobacco industry’s relentless targeting of our nation’s children will no longer be tolerated,” she emphasized.

View the surgeon general’s video message and access additional e-cigarette information here.

Teenage use of vaping devices jumped significantly in the past year, with 37% of 12th-grade students reporting any vaping in 2018, compared with 28% in 2017, data announced Dec. 17 from the 2018 Monitoring the Future survey show.

LiudmylaSupynska/Thinkstock

In particular, nicotine vaping use in the 30 days prior to the survey nearly doubled among high school seniors, from approximately 11% in 2017 to 21% in 2018. Nicotine vaping also increased by 7.9% (from 8.2% to 16.1%) among 10th graders and by 2.6% (from 3.5% to 6.1%) among 8th graders, according to the survey results.

Vaping involves using a device such as an e-cigarette to inhale a heated aerosol product that usually contains nicotine but can be used to administer other types of drugs, said Nora D. Volkow, MD, director of the National Institute on Drug Abuse at the National Institutes of Health, in a press conference announcing the findings.

The increased prevalence of nicotine vaping in 10th and 12th graders is the largest annual increase in use of any substance recorded by Monitoring the Future, said Richard A. Miech, PhD, MPH, of the Institute for Social Research at the University of Michigan, Ann Arbor, and the principal survey investigator. “Something about this delivery device of vaping seems to really appeal to kids,” he said. The flavorings, concealability of the devices (which can be about the size of a flash drive), and ease of use seem to be contributing to the popularity of vaping, Dr. Miech added.

In addition, marijuana vaping increased significantly across all three grade levels in 2018 from 2017. Within 30 days of the survey, marijuana vaping increased from 4.9% to 7.5% in 12th graders, from 4.3% to 7.0% in 10th graders, and from 1.6% to 2.6% in 8th graders.

A take-home message for clinicians is the need to emphasize to teens that “vaping is not innocuous and not harmless,” said Dr. Miech in a question-and-answer session. Of note, data from multiple studies show that children who vape are about five times more likely to smoke cigarettes, he said.

The vaping devices are manufactured to deliver drugs into the lungs and ultimately high concentrations into the brain – which suggests the use of vaping devices to deliver other types of drugs might increase in the future, Dr. Volkow added.

Use of most other substances, including inhalants, heroin, cocaine, ecstasy, overall marijuana use, alcohol use, and extreme binge drinking remained stable, the researchers said. Cigarette smoking declined slightly among 12th graders but did not change significantly among 8th or 10th graders. Use of prescription opioids and tranquilizers declined in 2018 across all age groups.

“Vaping is reversing hard-fought declines in the number of adolescents who use nicotine,” Dr. Miech said in the news release announcing the results. “These results suggest that vaping is leading youth into nicotine use and nicotine addiction, not away from it.”

The data on vaping and nicotine use among American teens were published in a letter (N Engl J Med. 2018 Dec 17. doi: 10.1056/NEJMc1814130) – with a warning. “These results indicate that the policies in place as of the 2017-2018 school year were not sufficient to stop the spread of nicotine vaping among adolescents,” wrote the authors, led by Dr. Miech. “The rapid entry of new vaping devices on the market ... will require continual updates and modification strategies to keep adolescents from vaping and its associated negative health effects.”

The Monitoring the Future survey tracks annual drug use and drug use attitudes in a nationally representative sample of U.S. students in 8th, 10th, and 12th grades. This year’s survey included 44,482 participants. The survey is funded by a government grant to the University of Michigan, Ann Arbor, from the NIH’s NIDA.

Teenage use of vaping devices jumped significantly in the past year, with 37% of 12th-grade students reporting any vaping in 2018, compared with 28% in 2017, data announced Dec. 17 from the 2018 Monitoring the Future survey show.

LiudmylaSupynska/Thinkstock

In particular, nicotine vaping use in the 30 days prior to the survey nearly doubled among high school seniors, from approximately 11% in 2017 to 21% in 2018. Nicotine vaping also increased by 7.9% (from 8.2% to 16.1%) among 10th graders and by 2.6% (from 3.5% to 6.1%) among 8th graders, according to the survey results.

Vaping involves using a device such as an e-cigarette to inhale a heated aerosol product that usually contains nicotine but can be used to administer other types of drugs, said Nora D. Volkow, MD, director of the National Institute on Drug Abuse at the National Institutes of Health, in a press conference announcing the findings.

The increased prevalence of nicotine vaping in 10th and 12th graders is the largest annual increase in use of any substance recorded by Monitoring the Future, said Richard A. Miech, PhD, MPH, of the Institute for Social Research at the University of Michigan, Ann Arbor, and the principal survey investigator. “Something about this delivery device of vaping seems to really appeal to kids,” he said. The flavorings, concealability of the devices (which can be about the size of a flash drive), and ease of use seem to be contributing to the popularity of vaping, Dr. Miech added.

In addition, marijuana vaping increased significantly across all three grade levels in 2018 from 2017. Within 30 days of the survey, marijuana vaping increased from 4.9% to 7.5% in 12th graders, from 4.3% to 7.0% in 10th graders, and from 1.6% to 2.6% in 8th graders.

A take-home message for clinicians is the need to emphasize to teens that “vaping is not innocuous and not harmless,” said Dr. Miech in a question-and-answer session. Of note, data from multiple studies show that children who vape are about five times more likely to smoke cigarettes, he said.

The vaping devices are manufactured to deliver drugs into the lungs and ultimately high concentrations into the brain – which suggests the use of vaping devices to deliver other types of drugs might increase in the future, Dr. Volkow added.

Use of most other substances, including inhalants, heroin, cocaine, ecstasy, overall marijuana use, alcohol use, and extreme binge drinking remained stable, the researchers said. Cigarette smoking declined slightly among 12th graders but did not change significantly among 8th or 10th graders. Use of prescription opioids and tranquilizers declined in 2018 across all age groups.

“Vaping is reversing hard-fought declines in the number of adolescents who use nicotine,” Dr. Miech said in the news release announcing the results. “These results suggest that vaping is leading youth into nicotine use and nicotine addiction, not away from it.”

The data on vaping and nicotine use among American teens were published in a letter (N Engl J Med. 2018 Dec 17. doi: 10.1056/NEJMc1814130) – with a warning. “These results indicate that the policies in place as of the 2017-2018 school year were not sufficient to stop the spread of nicotine vaping among adolescents,” wrote the authors, led by Dr. Miech. “The rapid entry of new vaping devices on the market ... will require continual updates and modification strategies to keep adolescents from vaping and its associated negative health effects.”

The Monitoring the Future survey tracks annual drug use and drug use attitudes in a nationally representative sample of U.S. students in 8th, 10th, and 12th grades. This year’s survey included 44,482 participants. The survey is funded by a government grant to the University of Michigan, Ann Arbor, from the NIH’s NIDA.

Teenage use of vaping devices jumped significantly in the past year, with 37% of 12th-grade students reporting any vaping in 2018, compared with 28% in 2017, data announced Dec. 17 from the 2018 Monitoring the Future survey show.

LiudmylaSupynska/Thinkstock

In particular, nicotine vaping use in the 30 days prior to the survey nearly doubled among high school seniors, from approximately 11% in 2017 to 21% in 2018. Nicotine vaping also increased by 7.9% (from 8.2% to 16.1%) among 10th graders and by 2.6% (from 3.5% to 6.1%) among 8th graders, according to the survey results.

Vaping involves using a device such as an e-cigarette to inhale a heated aerosol product that usually contains nicotine but can be used to administer other types of drugs, said Nora D. Volkow, MD, director of the National Institute on Drug Abuse at the National Institutes of Health, in a press conference announcing the findings.

The increased prevalence of nicotine vaping in 10th and 12th graders is the largest annual increase in use of any substance recorded by Monitoring the Future, said Richard A. Miech, PhD, MPH, of the Institute for Social Research at the University of Michigan, Ann Arbor, and the principal survey investigator. “Something about this delivery device of vaping seems to really appeal to kids,” he said. The flavorings, concealability of the devices (which can be about the size of a flash drive), and ease of use seem to be contributing to the popularity of vaping, Dr. Miech added.

In addition, marijuana vaping increased significantly across all three grade levels in 2018 from 2017. Within 30 days of the survey, marijuana vaping increased from 4.9% to 7.5% in 12th graders, from 4.3% to 7.0% in 10th graders, and from 1.6% to 2.6% in 8th graders.

A take-home message for clinicians is the need to emphasize to teens that “vaping is not innocuous and not harmless,” said Dr. Miech in a question-and-answer session. Of note, data from multiple studies show that children who vape are about five times more likely to smoke cigarettes, he said.

The vaping devices are manufactured to deliver drugs into the lungs and ultimately high concentrations into the brain – which suggests the use of vaping devices to deliver other types of drugs might increase in the future, Dr. Volkow added.

Use of most other substances, including inhalants, heroin, cocaine, ecstasy, overall marijuana use, alcohol use, and extreme binge drinking remained stable, the researchers said. Cigarette smoking declined slightly among 12th graders but did not change significantly among 8th or 10th graders. Use of prescription opioids and tranquilizers declined in 2018 across all age groups.

“Vaping is reversing hard-fought declines in the number of adolescents who use nicotine,” Dr. Miech said in the news release announcing the results. “These results suggest that vaping is leading youth into nicotine use and nicotine addiction, not away from it.”

The data on vaping and nicotine use among American teens were published in a letter (N Engl J Med. 2018 Dec 17. doi: 10.1056/NEJMc1814130) – with a warning. “These results indicate that the policies in place as of the 2017-2018 school year were not sufficient to stop the spread of nicotine vaping among adolescents,” wrote the authors, led by Dr. Miech. “The rapid entry of new vaping devices on the market ... will require continual updates and modification strategies to keep adolescents from vaping and its associated negative health effects.”

The Monitoring the Future survey tracks annual drug use and drug use attitudes in a nationally representative sample of U.S. students in 8th, 10th, and 12th grades. This year’s survey included 44,482 participants. The survey is funded by a government grant to the University of Michigan, Ann Arbor, from the NIH’s NIDA.

Reprocessed duodenoscopes are more contaminated than expected, with up to 3% of samples testing positive for disease-causing bacteria including Escherichia coli and Staphylococcus aureus, according to an updated safety communication issued by the Food and Drug Administration on December 10.

“Because of the higher-than-expected contamination rates and to help protect patients from bacterial infections associated with the use of duodenoscopes, we have included in today’s safety communication updated recommendations regarding steps that health care providers can take to enhance duodenoscope reprocessing,” Jeff Shuren, MD, director of the Center for Devices and Radiological Health, wrote in the statement.

The FDA advised clinicians to follow additional cleaning measures including microbiological culturing, sterilization, use of a liquid chemical sterilant processing system, and repeated high-level disinfection beyond what is recommended by duodenoscope manufacturers.

The interim data cited in the safety communication come from postmarket surveillance studies conducted by duodenoscope manufacturers at the FDA’s request as part of the agency’s ongoing efforts to prevent patient infections caused by contaminated duodenoscopes. In addition to the positive tests for disease-causing bacteria, up to 3% of properly collected samples contained more than 100 colony-forming units of other organisms unlikely to cause infection. However, the presence of such organisms further highlights the failure of the current reprocessing protocol to adequately clean the devices, according to the FDA.

Dr. Shuren emphasized that the risk of infection from a duodenoscope for an individual patient remains low and that infection rates have declined in recent years in response to the FDA’s enhanced safety measures and stated that the agency remains “committed to enhancing the safety margin of procedures with reprocessed medical devices.”

Read the full safety communication here: https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm628020.htm.

The AGA Center for GI Innovation and Technology supports innovation and the development of new technology in gastroenterology, hepatology, nutrition and obesity by guiding medical device and therapeutics innovators through the technology development and adoption process. Learn more at www.gastro.org/CGIT

Reprocessed duodenoscopes are more contaminated than expected, with up to 3% of samples testing positive for disease-causing bacteria including Escherichia coli and Staphylococcus aureus, according to an updated safety communication issued by the Food and Drug Administration on December 10.

“Because of the higher-than-expected contamination rates and to help protect patients from bacterial infections associated with the use of duodenoscopes, we have included in today’s safety communication updated recommendations regarding steps that health care providers can take to enhance duodenoscope reprocessing,” Jeff Shuren, MD, director of the Center for Devices and Radiological Health, wrote in the statement.

The FDA advised clinicians to follow additional cleaning measures including microbiological culturing, sterilization, use of a liquid chemical sterilant processing system, and repeated high-level disinfection beyond what is recommended by duodenoscope manufacturers.

The interim data cited in the safety communication come from postmarket surveillance studies conducted by duodenoscope manufacturers at the FDA’s request as part of the agency’s ongoing efforts to prevent patient infections caused by contaminated duodenoscopes. In addition to the positive tests for disease-causing bacteria, up to 3% of properly collected samples contained more than 100 colony-forming units of other organisms unlikely to cause infection. However, the presence of such organisms further highlights the failure of the current reprocessing protocol to adequately clean the devices, according to the FDA.

Dr. Shuren emphasized that the risk of infection from a duodenoscope for an individual patient remains low and that infection rates have declined in recent years in response to the FDA’s enhanced safety measures and stated that the agency remains “committed to enhancing the safety margin of procedures with reprocessed medical devices.”

Read the full safety communication here: https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm628020.htm.

The AGA Center for GI Innovation and Technology supports innovation and the development of new technology in gastroenterology, hepatology, nutrition and obesity by guiding medical device and therapeutics innovators through the technology development and adoption process. Learn more at www.gastro.org/CGIT

Reprocessed duodenoscopes are more contaminated than expected, with up to 3% of samples testing positive for disease-causing bacteria including Escherichia coli and Staphylococcus aureus, according to an updated safety communication issued by the Food and Drug Administration on December 10.

“Because of the higher-than-expected contamination rates and to help protect patients from bacterial infections associated with the use of duodenoscopes, we have included in today’s safety communication updated recommendations regarding steps that health care providers can take to enhance duodenoscope reprocessing,” Jeff Shuren, MD, director of the Center for Devices and Radiological Health, wrote in the statement.

The FDA advised clinicians to follow additional cleaning measures including microbiological culturing, sterilization, use of a liquid chemical sterilant processing system, and repeated high-level disinfection beyond what is recommended by duodenoscope manufacturers.

The interim data cited in the safety communication come from postmarket surveillance studies conducted by duodenoscope manufacturers at the FDA’s request as part of the agency’s ongoing efforts to prevent patient infections caused by contaminated duodenoscopes. In addition to the positive tests for disease-causing bacteria, up to 3% of properly collected samples contained more than 100 colony-forming units of other organisms unlikely to cause infection. However, the presence of such organisms further highlights the failure of the current reprocessing protocol to adequately clean the devices, according to the FDA.

Dr. Shuren emphasized that the risk of infection from a duodenoscope for an individual patient remains low and that infection rates have declined in recent years in response to the FDA’s enhanced safety measures and stated that the agency remains “committed to enhancing the safety margin of procedures with reprocessed medical devices.”

Read the full safety communication here: https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm628020.htm.

The AGA Center for GI Innovation and Technology supports innovation and the development of new technology in gastroenterology, hepatology, nutrition and obesity by guiding medical device and therapeutics innovators through the technology development and adoption process. Learn more at www.gastro.org/CGIT

The effectiveness of the influenza vaccine declined significantly after 9 months, according to 5 years of data from approximately 15,000 children in Hong Kong.

CAP53/iStockphoto.com

The vaccine is known to last less than a year, but the findings support the need for more vaccine availability in areas where influenza activity occurs year-round, wrote Shuo Feng, PhD, and Susan S. Chiu, MD, of the University of Hong Kong, and their colleagues.

In a study published in the Lancet Respiratory Medicine, the researchers reviewed how vaccine effectiveness changed over time by analyzing data from children aged 6 months to 17 years admitted to a Hong Kong hospital between 2012 and 2017. The study population involved 15,695 children hospitalized for respiratory infections, including 2,500 who were positive for influenza A or B and 13,195 who were negative. Of these, 6.4% of the positive patients and 11% of the negative patients had been vaccinated; 70% to 80% of the vaccinations occurred before the end of December of a given year.

Overall, the vaccination effectiveness rate was 79% for 0.5 to 2 months after vaccination, then dropped to 60% at 2-4 months, 57% at 4-6 months, and 45% at 6-9 months.

The researchers estimated vaccine effectiveness by three time periods: September to December, January to April, and May to August. Across seasons, vaccine effectiveness for all age groups was 79% for September to December, 67% for January to April, and 43% for May to August.

The study results were strengthened by the inclusion of year-round activity, but limited by several factors including lack of data on patients’ vaccination history and the specifics of each year’s flu virus, and lack of generalizability to an adult population, the researchers said.

However, the findings support data from previous studies on the effectiveness of annual vaccination, with the optimal timing from October to December in Hong Kong, they said. “Improved influenza vaccines are needed to provide year-round protection for children, particularly in subtropical and tropical locations,” they added.

The study was supported by the Health and Medical Research Fund and the Research Grants Council, Hong Kong. The lead authors had no financial conflicts to disclose.

SOURCE: Feng S et al. Lancet Respir Med. 2018;6:925-34.

The effectiveness of the influenza vaccine declined significantly after 9 months, according to 5 years of data from approximately 15,000 children in Hong Kong.

CAP53/iStockphoto.com

The vaccine is known to last less than a year, but the findings support the need for more vaccine availability in areas where influenza activity occurs year-round, wrote Shuo Feng, PhD, and Susan S. Chiu, MD, of the University of Hong Kong, and their colleagues.

In a study published in the Lancet Respiratory Medicine, the researchers reviewed how vaccine effectiveness changed over time by analyzing data from children aged 6 months to 17 years admitted to a Hong Kong hospital between 2012 and 2017. The study population involved 15,695 children hospitalized for respiratory infections, including 2,500 who were positive for influenza A or B and 13,195 who were negative. Of these, 6.4% of the positive patients and 11% of the negative patients had been vaccinated; 70% to 80% of the vaccinations occurred before the end of December of a given year.

Overall, the vaccination effectiveness rate was 79% for 0.5 to 2 months after vaccination, then dropped to 60% at 2-4 months, 57% at 4-6 months, and 45% at 6-9 months.

The researchers estimated vaccine effectiveness by three time periods: September to December, January to April, and May to August. Across seasons, vaccine effectiveness for all age groups was 79% for September to December, 67% for January to April, and 43% for May to August.

The study results were strengthened by the inclusion of year-round activity, but limited by several factors including lack of data on patients’ vaccination history and the specifics of each year’s flu virus, and lack of generalizability to an adult population, the researchers said.

However, the findings support data from previous studies on the effectiveness of annual vaccination, with the optimal timing from October to December in Hong Kong, they said. “Improved influenza vaccines are needed to provide year-round protection for children, particularly in subtropical and tropical locations,” they added.

The study was supported by the Health and Medical Research Fund and the Research Grants Council, Hong Kong. The lead authors had no financial conflicts to disclose.

SOURCE: Feng S et al. Lancet Respir Med. 2018;6:925-34.

The effectiveness of the influenza vaccine declined significantly after 9 months, according to 5 years of data from approximately 15,000 children in Hong Kong.

CAP53/iStockphoto.com

The vaccine is known to last less than a year, but the findings support the need for more vaccine availability in areas where influenza activity occurs year-round, wrote Shuo Feng, PhD, and Susan S. Chiu, MD, of the University of Hong Kong, and their colleagues.

In a study published in the Lancet Respiratory Medicine, the researchers reviewed how vaccine effectiveness changed over time by analyzing data from children aged 6 months to 17 years admitted to a Hong Kong hospital between 2012 and 2017. The study population involved 15,695 children hospitalized for respiratory infections, including 2,500 who were positive for influenza A or B and 13,195 who were negative. Of these, 6.4% of the positive patients and 11% of the negative patients had been vaccinated; 70% to 80% of the vaccinations occurred before the end of December of a given year.

Overall, the vaccination effectiveness rate was 79% for 0.5 to 2 months after vaccination, then dropped to 60% at 2-4 months, 57% at 4-6 months, and 45% at 6-9 months.

The researchers estimated vaccine effectiveness by three time periods: September to December, January to April, and May to August. Across seasons, vaccine effectiveness for all age groups was 79% for September to December, 67% for January to April, and 43% for May to August.

The study results were strengthened by the inclusion of year-round activity, but limited by several factors including lack of data on patients’ vaccination history and the specifics of each year’s flu virus, and lack of generalizability to an adult population, the researchers said.

However, the findings support data from previous studies on the effectiveness of annual vaccination, with the optimal timing from October to December in Hong Kong, they said. “Improved influenza vaccines are needed to provide year-round protection for children, particularly in subtropical and tropical locations,” they added.

The study was supported by the Health and Medical Research Fund and the Research Grants Council, Hong Kong. The lead authors had no financial conflicts to disclose.

SOURCE: Feng S et al. Lancet Respir Med. 2018;6:925-34.

Reprocessed duodenoscopes are more contaminated than expected, with up to 3% of samples testing positive for disease-causing bacteria including Escherichia coli and Staphylococcus aureus, according to an updated safety communication issued by the Food and Drug Administration on December 10.

“Because of the higher-than-expected contamination rates and to help protect patients from bacterial infections associated with the use of duodenoscopes, we have included in today’s safety communication updated recommendations regarding steps that health care providers can take to enhance duodenoscope reprocessing,” Jeff Shuren, MD, director of the Center for Devices and Radiological Health, wrote in the statement.

The FDA advised clinicians to follow additional cleaning measures including microbiological culturing, sterilization, use of a liquid chemical sterilant processing system, and repeated high-level disinfection beyond what is recommended by duodenoscope manufacturers.

The interim data cited in the safety communication come from postmarket surveillance studies conducted by duodenoscope manufacturers at the FDA’s request as part of the agency’s ongoing efforts to prevent patient infections caused by contaminated duodenoscopes. In addition to the positive tests for disease-causing bacteria, up to 3% of properly collected samples contained more than 100 colony-forming units of other organisms unlikely to cause infection. However, the presence of such organisms further highlights the failure of the current reprocessing protocol to adequately clean the devices, according to the FDA.

Dr. Shuren emphasized that the risk of infection from a duodenoscope for an individual patient remains low and that infection rates have declined in recent years in response to the FDA’s enhanced safety measures and stated that the agency remains “committed to enhancing the safety margin of procedures with reprocessed medical devices.”

Read the full safety communication here: https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm628020.htm.

Reprocessed duodenoscopes are more contaminated than expected, with up to 3% of samples testing positive for disease-causing bacteria including Escherichia coli and Staphylococcus aureus, according to an updated safety communication issued by the Food and Drug Administration on December 10.

“Because of the higher-than-expected contamination rates and to help protect patients from bacterial infections associated with the use of duodenoscopes, we have included in today’s safety communication updated recommendations regarding steps that health care providers can take to enhance duodenoscope reprocessing,” Jeff Shuren, MD, director of the Center for Devices and Radiological Health, wrote in the statement.

The FDA advised clinicians to follow additional cleaning measures including microbiological culturing, sterilization, use of a liquid chemical sterilant processing system, and repeated high-level disinfection beyond what is recommended by duodenoscope manufacturers.

The interim data cited in the safety communication come from postmarket surveillance studies conducted by duodenoscope manufacturers at the FDA’s request as part of the agency’s ongoing efforts to prevent patient infections caused by contaminated duodenoscopes. In addition to the positive tests for disease-causing bacteria, up to 3% of properly collected samples contained more than 100 colony-forming units of other organisms unlikely to cause infection. However, the presence of such organisms further highlights the failure of the current reprocessing protocol to adequately clean the devices, according to the FDA.

Dr. Shuren emphasized that the risk of infection from a duodenoscope for an individual patient remains low and that infection rates have declined in recent years in response to the FDA’s enhanced safety measures and stated that the agency remains “committed to enhancing the safety margin of procedures with reprocessed medical devices.”

Read the full safety communication here: https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm628020.htm.

Reprocessed duodenoscopes are more contaminated than expected, with up to 3% of samples testing positive for disease-causing bacteria including Escherichia coli and Staphylococcus aureus, according to an updated safety communication issued by the Food and Drug Administration on December 10.

“Because of the higher-than-expected contamination rates and to help protect patients from bacterial infections associated with the use of duodenoscopes, we have included in today’s safety communication updated recommendations regarding steps that health care providers can take to enhance duodenoscope reprocessing,” Jeff Shuren, MD, director of the Center for Devices and Radiological Health, wrote in the statement.

The FDA advised clinicians to follow additional cleaning measures including microbiological culturing, sterilization, use of a liquid chemical sterilant processing system, and repeated high-level disinfection beyond what is recommended by duodenoscope manufacturers.

The interim data cited in the safety communication come from postmarket surveillance studies conducted by duodenoscope manufacturers at the FDA’s request as part of the agency’s ongoing efforts to prevent patient infections caused by contaminated duodenoscopes. In addition to the positive tests for disease-causing bacteria, up to 3% of properly collected samples contained more than 100 colony-forming units of other organisms unlikely to cause infection. However, the presence of such organisms further highlights the failure of the current reprocessing protocol to adequately clean the devices, according to the FDA.

Dr. Shuren emphasized that the risk of infection from a duodenoscope for an individual patient remains low and that infection rates have declined in recent years in response to the FDA’s enhanced safety measures and stated that the agency remains “committed to enhancing the safety margin of procedures with reprocessed medical devices.”

Read the full safety communication here: https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm628020.htm.

Severe sleep-disordered breathing was significantly associated with more aggressive skin cancer in a study of 443 adults.

Dlumen/Thinkstock

Sleep-disordered breathing (SDB) has been associated with increased cancer risk and mortality, but no large studies have examined the association in specific cancers, wrote Miguel Angel Martinez-Garcia, MD, of La Fe University and Polytechnic Hospital, Valencia, Spain, and his colleagues.

The researchers conducted a sleep study of 443 adults with melanoma within 6 months of their diagnoses. The findings were published in the journal CHEST®. Overall, patients with more severe sleep apnea were nearly twice as likely to have aggressive type melanoma, compared with those with less severe sleep apnea.

Sleep apnea was defined via the Apnea Hypopnea Index (AHI) and the desaturation indices (DI). Aggressive melanoma was defined as a Breslow index greater than 1 mm, compared with 1 mm or less.

Patients with AHI greater than 15.6 events per hour or in the DI4% tertile (more than 9.3 desaturations per hour) were approximately twice as likely (1.94 and 1.93 times, respectively) to have a more aggressive melanoma as were those with less severe sleep apnea, after adjustment for age, gender, body mass index, and melanoma location.

The average age of the patients was 60 years, 51% were male, and the average time between the melanoma diagnosis and the sleep study was 82 days. Sleep symptoms were not significantly different between the patients with aggressive or less aggressive melanoma. However, in addition to more severe sleep apnea, those with aggressive melanoma were significantly more likely to be older, male, and have a higher BMI than were those with less aggressive disease.

“Among the most salient findings were the dependence of the association between SDB and the markers of melanoma aggressiveness on both age and the actual indicators of tumor aggressiveness,” the researchers noted. The association was significant in patients younger than 55 years only if their Breslow index was greater than 2 mm, the researchers said.

The study findings were limited by the absence of full overnight polysomnography to assess SDB because not all participating centers had access to that option, the researchers noted. However, the results support an independent link between sleep apnea and common measures of aggressive melanoma, especially in younger patients, they said. “Future prospective studies are needed to confirm whether the presence and treatment of SDB and its evolution over time are also associated with poor melanoma outcomes, including death, the pathophysiological mechanisms underlying this association,” they added.

The study was supported in part by Fondo de Investigation Sanitaria, SEPAR, Red Respira, and Sociedad Valenciana de Neumología. The researchers had no financial conflicts to disclose

SOURCE: Martinez-Garcia M et al. CHEST. 2018; doi: 10.1016/j.chest.2018.07.015.

Severe sleep-disordered breathing was significantly associated with more aggressive skin cancer in a study of 443 adults.

Dlumen/Thinkstock

Sleep-disordered breathing (SDB) has been associated with increased cancer risk and mortality, but no large studies have examined the association in specific cancers, wrote Miguel Angel Martinez-Garcia, MD, of La Fe University and Polytechnic Hospital, Valencia, Spain, and his colleagues.

The researchers conducted a sleep study of 443 adults with melanoma within 6 months of their diagnoses. The findings were published in the journal CHEST®. Overall, patients with more severe sleep apnea were nearly twice as likely to have aggressive type melanoma, compared with those with less severe sleep apnea.

Sleep apnea was defined via the Apnea Hypopnea Index (AHI) and the desaturation indices (DI). Aggressive melanoma was defined as a Breslow index greater than 1 mm, compared with 1 mm or less.

Patients with AHI greater than 15.6 events per hour or in the DI4% tertile (more than 9.3 desaturations per hour) were approximately twice as likely (1.94 and 1.93 times, respectively) to have a more aggressive melanoma as were those with less severe sleep apnea, after adjustment for age, gender, body mass index, and melanoma location.

The average age of the patients was 60 years, 51% were male, and the average time between the melanoma diagnosis and the sleep study was 82 days. Sleep symptoms were not significantly different between the patients with aggressive or less aggressive melanoma. However, in addition to more severe sleep apnea, those with aggressive melanoma were significantly more likely to be older, male, and have a higher BMI than were those with less aggressive disease.

“Among the most salient findings were the dependence of the association between SDB and the markers of melanoma aggressiveness on both age and the actual indicators of tumor aggressiveness,” the researchers noted. The association was significant in patients younger than 55 years only if their Breslow index was greater than 2 mm, the researchers said.

The study findings were limited by the absence of full overnight polysomnography to assess SDB because not all participating centers had access to that option, the researchers noted. However, the results support an independent link between sleep apnea and common measures of aggressive melanoma, especially in younger patients, they said. “Future prospective studies are needed to confirm whether the presence and treatment of SDB and its evolution over time are also associated with poor melanoma outcomes, including death, the pathophysiological mechanisms underlying this association,” they added.

The study was supported in part by Fondo de Investigation Sanitaria, SEPAR, Red Respira, and Sociedad Valenciana de Neumología. The researchers had no financial conflicts to disclose

SOURCE: Martinez-Garcia M et al. CHEST. 2018; doi: 10.1016/j.chest.2018.07.015.

Severe sleep-disordered breathing was significantly associated with more aggressive skin cancer in a study of 443 adults.

Dlumen/Thinkstock

Sleep-disordered breathing (SDB) has been associated with increased cancer risk and mortality, but no large studies have examined the association in specific cancers, wrote Miguel Angel Martinez-Garcia, MD, of La Fe University and Polytechnic Hospital, Valencia, Spain, and his colleagues.

The researchers conducted a sleep study of 443 adults with melanoma within 6 months of their diagnoses. The findings were published in the journal CHEST®. Overall, patients with more severe sleep apnea were nearly twice as likely to have aggressive type melanoma, compared with those with less severe sleep apnea.

Sleep apnea was defined via the Apnea Hypopnea Index (AHI) and the desaturation indices (DI). Aggressive melanoma was defined as a Breslow index greater than 1 mm, compared with 1 mm or less.

Patients with AHI greater than 15.6 events per hour or in the DI4% tertile (more than 9.3 desaturations per hour) were approximately twice as likely (1.94 and 1.93 times, respectively) to have a more aggressive melanoma as were those with less severe sleep apnea, after adjustment for age, gender, body mass index, and melanoma location.

The average age of the patients was 60 years, 51% were male, and the average time between the melanoma diagnosis and the sleep study was 82 days. Sleep symptoms were not significantly different between the patients with aggressive or less aggressive melanoma. However, in addition to more severe sleep apnea, those with aggressive melanoma were significantly more likely to be older, male, and have a higher BMI than were those with less aggressive disease.

“Among the most salient findings were the dependence of the association between SDB and the markers of melanoma aggressiveness on both age and the actual indicators of tumor aggressiveness,” the researchers noted. The association was significant in patients younger than 55 years only if their Breslow index was greater than 2 mm, the researchers said.

The study findings were limited by the absence of full overnight polysomnography to assess SDB because not all participating centers had access to that option, the researchers noted. However, the results support an independent link between sleep apnea and common measures of aggressive melanoma, especially in younger patients, they said. “Future prospective studies are needed to confirm whether the presence and treatment of SDB and its evolution over time are also associated with poor melanoma outcomes, including death, the pathophysiological mechanisms underlying this association,” they added.

The study was supported in part by Fondo de Investigation Sanitaria, SEPAR, Red Respira, and Sociedad Valenciana de Neumología. The researchers had no financial conflicts to disclose

SOURCE: Martinez-Garcia M et al. CHEST. 2018; doi: 10.1016/j.chest.2018.07.015.

Financial conflicts are often underreported by authors of clinical practice guidelines (CPGs) in several specialties including oncology, rheumatology, and gastroenterology, according to a pair of research letters published in JAMA Internal Medicine. The Institute of Medicine recommends that guideline authors include no more than 50% individuals with financial conflicts.

In one research letter, Rishad Khan, BSc, of the University of Toronto in Ontario and his colleagues reviewed data on undeclared financial conflicts of interest among authors of guidelines related to high-revenue medications.

The researchers identified CPGs via the National Guideline Clearinghouse and selected 18 CPGs for 10 high-revenue medications published between 2013 and 2017. Financial conflicts of interest were based on the Centers for Medicare & Medicaid Services Open Payments.

Of the 160 authors involved in the various guidelines, 79 (49.4%) disclosed a payment in the CPG or supplemental materials, and 50 (31.3%) disclosed payments from companies marketing 1 of the 10 high-revenue medications in the related guidelines.

Another 41 authors (25.6%) received but did not disclose payments from companies marketing 1 of the 10 high-revenue medications in CPGs.

Overall, 91 authors (56.9%) were found to have financial conflicts of interest that involved 1 of the 10 high-revenue medications, and “the median value of undeclared payments from companies marketing 1 of the 10 high-revenue medications recommended in the CPGs was $522 (interquartile range, $0-$40,444) from two companies,” the researchers said.

The study findings were limited by several factors including “potential inaccuracies in CMS-OP reporting, which are rarely corrected, and lack of generalizability outside the United States” and by the limited time frame for data collection, which may have led to underestimation of conflicts for the guidelines, the researchers noted. In addition, “we did not have access to guideline voting records and thus did not know when conflicted panel members recommended against a medication or recused themselves from voting,” they said.

Mr. Khan disclosed research funding from AbbVie and Ferring Pharmaceuticals.

In a second research letter, half of the authors of gastroenterology guidelines received payments from industry, wrote Tyler Combs, BS, of Oklahoma State University, Tulsa, and his colleagues. Previous studies have reviewed the financial conflicts of interest in specialties including oncology, dermatology, and otolaryngology, but financial conflicts of interest among authors of gastroenterology guidelines have not been examined, the researchers said.

Mr. Combs and his colleagues identified 15 CPGs published by the American College of Gastroenterology between 2014 and 2016. They identified 83 authors, with an average of 4 authors for each guideline. Overall, 53% of the authors received industry payments, according to based on data from the 2014 to 2016 Centers for Medicare & Medicaid Services Open Payments database (OPD).

However, OPD information was not always consistent with information published with the guidelines, the researchers noted. They found that 16 (19%) of the 83 authors both disclosed financial conflicts of interests in the CPGs and had received payments according to OPD or had disclosed no financial conflicts of interest and had received no payments according to OPD. In addition, 49 (34%) of 146 cumulative financial conflicts of interest disclosed in the CPGs and 148 relationships identified on OPD were both disclosed as financial conflicts of interest and evidenced by OPD payment records. In this review, the median total payment was $1,000, with an interquartile range from $0 to $39,938.

The study findings were limited by a relatively short 12-month time frame, the researchers noted. However, “our finding that FCOI [financial conflicts of interest] disclosure only corroborates with OPD payment records between 19% and 34% of the time also suggests that guidance from the ACG [American College of Gastroenterology] may be needed to improve FCOI disclosure efforts in future iterations of gastroenterology CPGs,” they said.

The researchers had no financial conflicts to disclose.
 

SOURCE: Combs T et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.4730; Khan R et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.5106.

Statement from the AGA on the integrity of AGA’s clinical guideline process

The American Gastroenterological Association (AGA) understands how important it is for AGA members, patients, and the public at large to have access to the most trustworthy, actionable, and evidence-based guidelines in order to achieve the highest possible quality of patient care. In developing guidelines, our goal is to maintain a high level of methodologic rigor through the utilization of an evidence-based approach that is very transparent. 

However, not all clinical guidelines are created with equal rigor. Clinicians should examine guidelines closely and consider whether or not they follow the Academy of Medicine’s (formerly the Institute of Medicine’s) standards for trustworthy clinical guidelines. The guideline should be based on a systematic review of the evidence, focus on transparency, have a rigorous conflict of interest system in place, include the involvement of an unconflicted Grading of Recommendations Assessment, Development and Evaluation (GRADE) system-trained methodologist, ideally as a cochair, and the recommendations should be concise and actionable. AGA follows a transparent, independent guideline development process that is not subject to company influence or bias and fully complies with the Academy of Medicine’s criteria for trustworthy guidelines.

AGA has been proactive in developing policies to minimize bias in our guidelines. AGA requires that the Chair of the Guideline Development Group, and a majority of Guideline (and other clinical practice documents) Development Group members are free of conflicts of interest relevant to the subject matter of the guideline. At the time of invitation, we ask our panel members to disclose any and all potential conflicts. Furthermore, all author disclosures are verified by means of accessing publicly available sources (such as the Centers for Medicare and Medicaid Services’ Open Payment database) prior to their involvement on the panel.  

AGA strives to be transparent in reporting commercial bias and independent of any industry influence in the development of our clinical practice documents. Our goal is to produce the most trustworthy, actionable, and evidence-based guidelines possible for our members. 

Learn more about AGA’s clinical guideline process (https://www.gastro.org/guidelines).

Yngve T. Falck-Ytter, MD, AGAF, is chair, and Shahnaz Sultan, MD, MHSc, AGAF, is chair-elect, AGA Institute Clinical Guidelines Committee.

Financial conflicts are often underreported by authors of clinical practice guidelines (CPGs) in several specialties including oncology, rheumatology, and gastroenterology, according to a pair of research letters published in JAMA Internal Medicine. The Institute of Medicine recommends that guideline authors include no more than 50% individuals with financial conflicts.

In one research letter, Rishad Khan, BSc, of the University of Toronto in Ontario and his colleagues reviewed data on undeclared financial conflicts of interest among authors of guidelines related to high-revenue medications.

The researchers identified CPGs via the National Guideline Clearinghouse and selected 18 CPGs for 10 high-revenue medications published between 2013 and 2017. Financial conflicts of interest were based on the Centers for Medicare & Medicaid Services Open Payments.

Of the 160 authors involved in the various guidelines, 79 (49.4%) disclosed a payment in the CPG or supplemental materials, and 50 (31.3%) disclosed payments from companies marketing 1 of the 10 high-revenue medications in the related guidelines.

Another 41 authors (25.6%) received but did not disclose payments from companies marketing 1 of the 10 high-revenue medications in CPGs.

Overall, 91 authors (56.9%) were found to have financial conflicts of interest that involved 1 of the 10 high-revenue medications, and “the median value of undeclared payments from companies marketing 1 of the 10 high-revenue medications recommended in the CPGs was $522 (interquartile range, $0-$40,444) from two companies,” the researchers said.

The study findings were limited by several factors including “potential inaccuracies in CMS-OP reporting, which are rarely corrected, and lack of generalizability outside the United States” and by the limited time frame for data collection, which may have led to underestimation of conflicts for the guidelines, the researchers noted. In addition, “we did not have access to guideline voting records and thus did not know when conflicted panel members recommended against a medication or recused themselves from voting,” they said.

Mr. Khan disclosed research funding from AbbVie and Ferring Pharmaceuticals.

In a second research letter, half of the authors of gastroenterology guidelines received payments from industry, wrote Tyler Combs, BS, of Oklahoma State University, Tulsa, and his colleagues. Previous studies have reviewed the financial conflicts of interest in specialties including oncology, dermatology, and otolaryngology, but financial conflicts of interest among authors of gastroenterology guidelines have not been examined, the researchers said.

Mr. Combs and his colleagues identified 15 CPGs published by the American College of Gastroenterology between 2014 and 2016. They identified 83 authors, with an average of 4 authors for each guideline. Overall, 53% of the authors received industry payments, according to based on data from the 2014 to 2016 Centers for Medicare & Medicaid Services Open Payments database (OPD).

However, OPD information was not always consistent with information published with the guidelines, the researchers noted. They found that 16 (19%) of the 83 authors both disclosed financial conflicts of interests in the CPGs and had received payments according to OPD or had disclosed no financial conflicts of interest and had received no payments according to OPD. In addition, 49 (34%) of 146 cumulative financial conflicts of interest disclosed in the CPGs and 148 relationships identified on OPD were both disclosed as financial conflicts of interest and evidenced by OPD payment records. In this review, the median total payment was $1,000, with an interquartile range from $0 to $39,938.

The study findings were limited by a relatively short 12-month time frame, the researchers noted. However, “our finding that FCOI [financial conflicts of interest] disclosure only corroborates with OPD payment records between 19% and 34% of the time also suggests that guidance from the ACG [American College of Gastroenterology] may be needed to improve FCOI disclosure efforts in future iterations of gastroenterology CPGs,” they said.

The researchers had no financial conflicts to disclose.
 

SOURCE: Combs T et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.4730; Khan R et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.5106.

Statement from the AGA on the integrity of AGA’s clinical guideline process

The American Gastroenterological Association (AGA) understands how important it is for AGA members, patients, and the public at large to have access to the most trustworthy, actionable, and evidence-based guidelines in order to achieve the highest possible quality of patient care. In developing guidelines, our goal is to maintain a high level of methodologic rigor through the utilization of an evidence-based approach that is very transparent. 

However, not all clinical guidelines are created with equal rigor. Clinicians should examine guidelines closely and consider whether or not they follow the Academy of Medicine’s (formerly the Institute of Medicine’s) standards for trustworthy clinical guidelines. The guideline should be based on a systematic review of the evidence, focus on transparency, have a rigorous conflict of interest system in place, include the involvement of an unconflicted Grading of Recommendations Assessment, Development and Evaluation (GRADE) system-trained methodologist, ideally as a cochair, and the recommendations should be concise and actionable. AGA follows a transparent, independent guideline development process that is not subject to company influence or bias and fully complies with the Academy of Medicine’s criteria for trustworthy guidelines.

AGA has been proactive in developing policies to minimize bias in our guidelines. AGA requires that the Chair of the Guideline Development Group, and a majority of Guideline (and other clinical practice documents) Development Group members are free of conflicts of interest relevant to the subject matter of the guideline. At the time of invitation, we ask our panel members to disclose any and all potential conflicts. Furthermore, all author disclosures are verified by means of accessing publicly available sources (such as the Centers for Medicare and Medicaid Services’ Open Payment database) prior to their involvement on the panel.  

AGA strives to be transparent in reporting commercial bias and independent of any industry influence in the development of our clinical practice documents. Our goal is to produce the most trustworthy, actionable, and evidence-based guidelines possible for our members. 

Learn more about AGA’s clinical guideline process (https://www.gastro.org/guidelines).

Yngve T. Falck-Ytter, MD, AGAF, is chair, and Shahnaz Sultan, MD, MHSc, AGAF, is chair-elect, AGA Institute Clinical Guidelines Committee.

Financial conflicts are often underreported by authors of clinical practice guidelines (CPGs) in several specialties including oncology, rheumatology, and gastroenterology, according to a pair of research letters published in JAMA Internal Medicine. The Institute of Medicine recommends that guideline authors include no more than 50% individuals with financial conflicts.

In one research letter, Rishad Khan, BSc, of the University of Toronto in Ontario and his colleagues reviewed data on undeclared financial conflicts of interest among authors of guidelines related to high-revenue medications.

The researchers identified CPGs via the National Guideline Clearinghouse and selected 18 CPGs for 10 high-revenue medications published between 2013 and 2017. Financial conflicts of interest were based on the Centers for Medicare & Medicaid Services Open Payments.

Of the 160 authors involved in the various guidelines, 79 (49.4%) disclosed a payment in the CPG or supplemental materials, and 50 (31.3%) disclosed payments from companies marketing 1 of the 10 high-revenue medications in the related guidelines.

Another 41 authors (25.6%) received but did not disclose payments from companies marketing 1 of the 10 high-revenue medications in CPGs.

Overall, 91 authors (56.9%) were found to have financial conflicts of interest that involved 1 of the 10 high-revenue medications, and “the median value of undeclared payments from companies marketing 1 of the 10 high-revenue medications recommended in the CPGs was $522 (interquartile range, $0-$40,444) from two companies,” the researchers said.

The study findings were limited by several factors including “potential inaccuracies in CMS-OP reporting, which are rarely corrected, and lack of generalizability outside the United States” and by the limited time frame for data collection, which may have led to underestimation of conflicts for the guidelines, the researchers noted. In addition, “we did not have access to guideline voting records and thus did not know when conflicted panel members recommended against a medication or recused themselves from voting,” they said.

Mr. Khan disclosed research funding from AbbVie and Ferring Pharmaceuticals.

In a second research letter, half of the authors of gastroenterology guidelines received payments from industry, wrote Tyler Combs, BS, of Oklahoma State University, Tulsa, and his colleagues. Previous studies have reviewed the financial conflicts of interest in specialties including oncology, dermatology, and otolaryngology, but financial conflicts of interest among authors of gastroenterology guidelines have not been examined, the researchers said.

Mr. Combs and his colleagues identified 15 CPGs published by the American College of Gastroenterology between 2014 and 2016. They identified 83 authors, with an average of 4 authors for each guideline. Overall, 53% of the authors received industry payments, according to based on data from the 2014 to 2016 Centers for Medicare & Medicaid Services Open Payments database (OPD).

However, OPD information was not always consistent with information published with the guidelines, the researchers noted. They found that 16 (19%) of the 83 authors both disclosed financial conflicts of interests in the CPGs and had received payments according to OPD or had disclosed no financial conflicts of interest and had received no payments according to OPD. In addition, 49 (34%) of 146 cumulative financial conflicts of interest disclosed in the CPGs and 148 relationships identified on OPD were both disclosed as financial conflicts of interest and evidenced by OPD payment records. In this review, the median total payment was $1,000, with an interquartile range from $0 to $39,938.

The study findings were limited by a relatively short 12-month time frame, the researchers noted. However, “our finding that FCOI [financial conflicts of interest] disclosure only corroborates with OPD payment records between 19% and 34% of the time also suggests that guidance from the ACG [American College of Gastroenterology] may be needed to improve FCOI disclosure efforts in future iterations of gastroenterology CPGs,” they said.

The researchers had no financial conflicts to disclose.
 

SOURCE: Combs T et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.4730; Khan R et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.5106.

Statement from the AGA on the integrity of AGA’s clinical guideline process

The American Gastroenterological Association (AGA) understands how important it is for AGA members, patients, and the public at large to have access to the most trustworthy, actionable, and evidence-based guidelines in order to achieve the highest possible quality of patient care. In developing guidelines, our goal is to maintain a high level of methodologic rigor through the utilization of an evidence-based approach that is very transparent. 

However, not all clinical guidelines are created with equal rigor. Clinicians should examine guidelines closely and consider whether or not they follow the Academy of Medicine’s (formerly the Institute of Medicine’s) standards for trustworthy clinical guidelines. The guideline should be based on a systematic review of the evidence, focus on transparency, have a rigorous conflict of interest system in place, include the involvement of an unconflicted Grading of Recommendations Assessment, Development and Evaluation (GRADE) system-trained methodologist, ideally as a cochair, and the recommendations should be concise and actionable. AGA follows a transparent, independent guideline development process that is not subject to company influence or bias and fully complies with the Academy of Medicine’s criteria for trustworthy guidelines.

AGA has been proactive in developing policies to minimize bias in our guidelines. AGA requires that the Chair of the Guideline Development Group, and a majority of Guideline (and other clinical practice documents) Development Group members are free of conflicts of interest relevant to the subject matter of the guideline. At the time of invitation, we ask our panel members to disclose any and all potential conflicts. Furthermore, all author disclosures are verified by means of accessing publicly available sources (such as the Centers for Medicare and Medicaid Services’ Open Payment database) prior to their involvement on the panel.  

AGA strives to be transparent in reporting commercial bias and independent of any industry influence in the development of our clinical practice documents. Our goal is to produce the most trustworthy, actionable, and evidence-based guidelines possible for our members. 

Learn more about AGA’s clinical guideline process (https://www.gastro.org/guidelines).

Yngve T. Falck-Ytter, MD, AGAF, is chair, and Shahnaz Sultan, MD, MHSc, AGAF, is chair-elect, AGA Institute Clinical Guidelines Committee.

Instances of stroke and arterial dissection in the head and neck have been reported in some multiple sclerosis patients soon after an infusion of alemtuzumab (Lemtrada), according to a safety announcement issued by the Food and Drug Administration on Nov. 29.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Since the FDA approved alemtuzumab in 2014 for relapsing forms of MS, 13 cases of ischemic and hemorrhagic stroke or arterial dissection have been reported worldwide via the FDA Adverse Event Reporting System, but “additional cases we are unaware of may have occurred,” the FDA said in the announcement.

Most of the patients who developed stroke or arterial lining tears showed symptoms within a day of taking the medication, although one patient reported symptoms three days after treatment. The drug is given via intravenous infusion and is generally reserved for patients with relapsing MS who have not responded adequately to other approved MS medications, according to the FDA.

Symptoms include sudden onset of the following: severe headache or neck pain; numbness or weakness in the arms or legs, especially on only one side of the body; confusion or trouble speaking or understanding speech; vision problems in one or both eyes; and dizziness, loss of balance, or difficulty walking.

As a result of the reports, the FDA has updated the drug label prescribing information and the patient Medication Guide to reflect these risks, and added the risk of stroke to the medication’s existing boxed warning.

Health care providers should remind patients of the potential for stroke and arterial dissection at each treatment visit and advise them to seek immediate medical attention if they experience any of the symptoms reported in previous cases. “The diagnosis is often complicated because early symptoms such as headache and neck pain are not specific,” according to the agency, but patients complaining of such symptoms should be evaluated immediately.

Alemtuzumab was also approved in May 2001 for treating B-cell chronic lymphocytic leukemia (B-CLL) under the brand name Campath. The FDA will update the Campath label to reflect the new warnings and risks.

Instances of stroke and arterial dissection in the head and neck have been reported in some multiple sclerosis patients soon after an infusion of alemtuzumab (Lemtrada), according to a safety announcement issued by the Food and Drug Administration on Nov. 29.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Since the FDA approved alemtuzumab in 2014 for relapsing forms of MS, 13 cases of ischemic and hemorrhagic stroke or arterial dissection have been reported worldwide via the FDA Adverse Event Reporting System, but “additional cases we are unaware of may have occurred,” the FDA said in the announcement.

Most of the patients who developed stroke or arterial lining tears showed symptoms within a day of taking the medication, although one patient reported symptoms three days after treatment. The drug is given via intravenous infusion and is generally reserved for patients with relapsing MS who have not responded adequately to other approved MS medications, according to the FDA.

Symptoms include sudden onset of the following: severe headache or neck pain; numbness or weakness in the arms or legs, especially on only one side of the body; confusion or trouble speaking or understanding speech; vision problems in one or both eyes; and dizziness, loss of balance, or difficulty walking.

As a result of the reports, the FDA has updated the drug label prescribing information and the patient Medication Guide to reflect these risks, and added the risk of stroke to the medication’s existing boxed warning.

Health care providers should remind patients of the potential for stroke and arterial dissection at each treatment visit and advise them to seek immediate medical attention if they experience any of the symptoms reported in previous cases. “The diagnosis is often complicated because early symptoms such as headache and neck pain are not specific,” according to the agency, but patients complaining of such symptoms should be evaluated immediately.

Alemtuzumab was also approved in May 2001 for treating B-cell chronic lymphocytic leukemia (B-CLL) under the brand name Campath. The FDA will update the Campath label to reflect the new warnings and risks.

Instances of stroke and arterial dissection in the head and neck have been reported in some multiple sclerosis patients soon after an infusion of alemtuzumab (Lemtrada), according to a safety announcement issued by the Food and Drug Administration on Nov. 29.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Since the FDA approved alemtuzumab in 2014 for relapsing forms of MS, 13 cases of ischemic and hemorrhagic stroke or arterial dissection have been reported worldwide via the FDA Adverse Event Reporting System, but “additional cases we are unaware of may have occurred,” the FDA said in the announcement.

Most of the patients who developed stroke or arterial lining tears showed symptoms within a day of taking the medication, although one patient reported symptoms three days after treatment. The drug is given via intravenous infusion and is generally reserved for patients with relapsing MS who have not responded adequately to other approved MS medications, according to the FDA.

Symptoms include sudden onset of the following: severe headache or neck pain; numbness or weakness in the arms or legs, especially on only one side of the body; confusion or trouble speaking or understanding speech; vision problems in one or both eyes; and dizziness, loss of balance, or difficulty walking.

As a result of the reports, the FDA has updated the drug label prescribing information and the patient Medication Guide to reflect these risks, and added the risk of stroke to the medication’s existing boxed warning.

Health care providers should remind patients of the potential for stroke and arterial dissection at each treatment visit and advise them to seek immediate medical attention if they experience any of the symptoms reported in previous cases. “The diagnosis is often complicated because early symptoms such as headache and neck pain are not specific,” according to the agency, but patients complaining of such symptoms should be evaluated immediately.

Alemtuzumab was also approved in May 2001 for treating B-cell chronic lymphocytic leukemia (B-CLL) under the brand name Campath. The FDA will update the Campath label to reflect the new warnings and risks.