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Christopher Palmer has been an associate editor at MDedge News since 2017. When he's not tidying grammar, he writes short pieces about breaking FDA announcements and approvals, as well as journal articles. He proudly holds a BA in English and philosophy. Follow him on Twitter @cmacmpalm.
Impella RP shows higher mortality in postapproval study
The Food and Drug Administration issued a letter on Feb. 4, 2019, to health care providers regarding interim results from a postapproval study for Abiomed’s Impella RP System because these results appear to have a higher mortality rate than was seen in premarket clinical studies.
As a condition of its approval, the FDA mandated Abiomed to perform a postapproval study (PAS); this study reflects use in a broader population than the premarket studies, which adhered to stricter inclusion and exclusion criteria.
Earlier in January, Abiomed submitted data to the FDA suggesting that differences in preimplant characteristics between patients in the PAS and those in the premarket clinical studies may explain the difference in mortality. Specifically, 16 of the 23 patients enrolled in the PAS would not have met the enrollment criteria for the premarket clinical studies because they were in cardiogenic shock for longer than 48 hours, experienced an in-hospital cardiac arrest, were treated with an intra-aortic balloon pump, or suffered a preimplant hypoxic or ischemic neurologic event.
“Although the FDA is concerned about the high mortality rate from the interim PAS results,” they wrote in the letter, which is available on the FDA website, “we believe that, when the device is used for the currently approved indication in appropriately selected patients, the benefits of the Impella RP system continue to outweigh the risks.”
The Food and Drug Administration issued a letter on Feb. 4, 2019, to health care providers regarding interim results from a postapproval study for Abiomed’s Impella RP System because these results appear to have a higher mortality rate than was seen in premarket clinical studies.
As a condition of its approval, the FDA mandated Abiomed to perform a postapproval study (PAS); this study reflects use in a broader population than the premarket studies, which adhered to stricter inclusion and exclusion criteria.
Earlier in January, Abiomed submitted data to the FDA suggesting that differences in preimplant characteristics between patients in the PAS and those in the premarket clinical studies may explain the difference in mortality. Specifically, 16 of the 23 patients enrolled in the PAS would not have met the enrollment criteria for the premarket clinical studies because they were in cardiogenic shock for longer than 48 hours, experienced an in-hospital cardiac arrest, were treated with an intra-aortic balloon pump, or suffered a preimplant hypoxic or ischemic neurologic event.
“Although the FDA is concerned about the high mortality rate from the interim PAS results,” they wrote in the letter, which is available on the FDA website, “we believe that, when the device is used for the currently approved indication in appropriately selected patients, the benefits of the Impella RP system continue to outweigh the risks.”
The Food and Drug Administration issued a letter on Feb. 4, 2019, to health care providers regarding interim results from a postapproval study for Abiomed’s Impella RP System because these results appear to have a higher mortality rate than was seen in premarket clinical studies.
As a condition of its approval, the FDA mandated Abiomed to perform a postapproval study (PAS); this study reflects use in a broader population than the premarket studies, which adhered to stricter inclusion and exclusion criteria.
Earlier in January, Abiomed submitted data to the FDA suggesting that differences in preimplant characteristics between patients in the PAS and those in the premarket clinical studies may explain the difference in mortality. Specifically, 16 of the 23 patients enrolled in the PAS would not have met the enrollment criteria for the premarket clinical studies because they were in cardiogenic shock for longer than 48 hours, experienced an in-hospital cardiac arrest, were treated with an intra-aortic balloon pump, or suffered a preimplant hypoxic or ischemic neurologic event.
“Although the FDA is concerned about the high mortality rate from the interim PAS results,” they wrote in the letter, which is available on the FDA website, “we believe that, when the device is used for the currently approved indication in appropriately selected patients, the benefits of the Impella RP system continue to outweigh the risks.”
New recall for CoaguChek test strips issued
According to a release, the Food and Drug Administration has identified this recall as Class I, which is the most serious type of recall and indicates that “use of these devices may cause serious injuries or death.”
These strips are used by patients taking warfarin to help determine the patients’ international normalized ratio, which doctors and patients then use to decide whether the dose is appropriate. Roche Diagnostics, the strips’ manufacturer, issued a recall in September 2018; the test strips distributed by Terrific Care and Medex, however, were not labeled or authorized for sale in the United States and were therefore not included in that original recall. According to the release, the strips in this recall, which was initiated Dec. 21, 2018, were purchased by Terrific Care and Medex from an unknown source and then distributed in the United States. On Jan. 28, 2019, Terrific Care sent an Urgent Medical Device Recall Notification Letter to customers.
The full recall is described on the FDA website.
According to a release, the Food and Drug Administration has identified this recall as Class I, which is the most serious type of recall and indicates that “use of these devices may cause serious injuries or death.”
These strips are used by patients taking warfarin to help determine the patients’ international normalized ratio, which doctors and patients then use to decide whether the dose is appropriate. Roche Diagnostics, the strips’ manufacturer, issued a recall in September 2018; the test strips distributed by Terrific Care and Medex, however, were not labeled or authorized for sale in the United States and were therefore not included in that original recall. According to the release, the strips in this recall, which was initiated Dec. 21, 2018, were purchased by Terrific Care and Medex from an unknown source and then distributed in the United States. On Jan. 28, 2019, Terrific Care sent an Urgent Medical Device Recall Notification Letter to customers.
The full recall is described on the FDA website.
According to a release, the Food and Drug Administration has identified this recall as Class I, which is the most serious type of recall and indicates that “use of these devices may cause serious injuries or death.”
These strips are used by patients taking warfarin to help determine the patients’ international normalized ratio, which doctors and patients then use to decide whether the dose is appropriate. Roche Diagnostics, the strips’ manufacturer, issued a recall in September 2018; the test strips distributed by Terrific Care and Medex, however, were not labeled or authorized for sale in the United States and were therefore not included in that original recall. According to the release, the strips in this recall, which was initiated Dec. 21, 2018, were purchased by Terrific Care and Medex from an unknown source and then distributed in the United States. On Jan. 28, 2019, Terrific Care sent an Urgent Medical Device Recall Notification Letter to customers.
The full recall is described on the FDA website.
FDA approves generic Advair Diskus
The Food and Drug Administration has approved a generic version of the Advair Diskus, a complex device-drug combination containing fluticasone propionate and salmeterol inhalation powder.
The generic device will be available in three strengths: fluticasone propionate 100 mcg/ salmeterol 50 mcg, fluticasone propionate 250 mcg/ salmeterol 50 mcg and fluticasone propionate 500 mcg/ salmeterol 50 mcg, according to the FDA announcement. It will be marketed by Mylan as Wixela Inhub and will launch in late February, according to a statement from Mylan.
Advair Diskus is among the most commonly used treatments for asthma and for chronic obstructive pulmonary disease (COPD), so it’s hoped this approval will increase access to the therapy, FDA officials said in a statement.
This approval is part of the FDA’s “longstanding commitment to advance access to lower cost, high quality generic alternatives,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “People living with asthma and COPD know too well the critical importance of having access to the treatment they need to feel better. Today’s approval will bring more competition to the market which will ultimately benefit the patients who rely on this drug.”
Wixela Inhub is indicated for twice-daily treatment of asthma in patients aged 4 years and older who are not adequately controlled by long-term asthma control treatments or whose disease warrants treatment with a combination of inhaled corticosteroids and long-acting beta agonists. It also is indicated for maintenance of COPD and reduction of COPD exacerbations.
The Food and Drug Administration has approved a generic version of the Advair Diskus, a complex device-drug combination containing fluticasone propionate and salmeterol inhalation powder.
The generic device will be available in three strengths: fluticasone propionate 100 mcg/ salmeterol 50 mcg, fluticasone propionate 250 mcg/ salmeterol 50 mcg and fluticasone propionate 500 mcg/ salmeterol 50 mcg, according to the FDA announcement. It will be marketed by Mylan as Wixela Inhub and will launch in late February, according to a statement from Mylan.
Advair Diskus is among the most commonly used treatments for asthma and for chronic obstructive pulmonary disease (COPD), so it’s hoped this approval will increase access to the therapy, FDA officials said in a statement.
This approval is part of the FDA’s “longstanding commitment to advance access to lower cost, high quality generic alternatives,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “People living with asthma and COPD know too well the critical importance of having access to the treatment they need to feel better. Today’s approval will bring more competition to the market which will ultimately benefit the patients who rely on this drug.”
Wixela Inhub is indicated for twice-daily treatment of asthma in patients aged 4 years and older who are not adequately controlled by long-term asthma control treatments or whose disease warrants treatment with a combination of inhaled corticosteroids and long-acting beta agonists. It also is indicated for maintenance of COPD and reduction of COPD exacerbations.
The Food and Drug Administration has approved a generic version of the Advair Diskus, a complex device-drug combination containing fluticasone propionate and salmeterol inhalation powder.
The generic device will be available in three strengths: fluticasone propionate 100 mcg/ salmeterol 50 mcg, fluticasone propionate 250 mcg/ salmeterol 50 mcg and fluticasone propionate 500 mcg/ salmeterol 50 mcg, according to the FDA announcement. It will be marketed by Mylan as Wixela Inhub and will launch in late February, according to a statement from Mylan.
Advair Diskus is among the most commonly used treatments for asthma and for chronic obstructive pulmonary disease (COPD), so it’s hoped this approval will increase access to the therapy, FDA officials said in a statement.
This approval is part of the FDA’s “longstanding commitment to advance access to lower cost, high quality generic alternatives,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “People living with asthma and COPD know too well the critical importance of having access to the treatment they need to feel better. Today’s approval will bring more competition to the market which will ultimately benefit the patients who rely on this drug.”
Wixela Inhub is indicated for twice-daily treatment of asthma in patients aged 4 years and older who are not adequately controlled by long-term asthma control treatments or whose disease warrants treatment with a combination of inhaled corticosteroids and long-acting beta agonists. It also is indicated for maintenance of COPD and reduction of COPD exacerbations.
Positive well-being may be ‘buffer against depression’ in adults with ASD
Positive well-being might function as a “resilient factor against depression” in autism spectrum disorder, results of a 12-month study of newly employed adults with ASD suggest.
“The potential for positive well-being to functioning as a buffer against depression in this study, as well as the broader benefits of positive well-being in the general population, suggests that positive well-being should be cultivated within the employment context,” wrote Darren Hedley, PhD, of La Trobe University, Melbourne, and his associates (Autism Res. 2019 Jan 24. doi: 10.1002/aur/2064).
To conduct the study, Dr. Hedley and his associates tested 36 (32 male) adults aged 18-57 with ASD who worked in an employment program supported by the Australian government. Among the measures used to assess mental health, social support, and job satisfaction were the Patient Health Questionnaire-9, the DSM-5 Dimensional Anxiety Scale, the Warwick-Edinburgh Mental Wellbeing Scale, the Interpersonal Support Evaluation List-12, and the Minnesota Satisfaction Questionnaire-Short Form.
Over the course of 12 months, Dr. Hedley and his associates found that the participants experienced a small increase in their daily living skills and a small drop in job satisfaction, but all other measures – except for depression – remained stable. . “These results are consistent with research in the general population that shows well-being functions as a buffer or protective factor against depression,” they wrote.
Dr. Hedley and his associates cited several limitations, including the small sample size and the absence of a comparative sample of adults with ASD engaged in open employment.
The full study can be found at Autism Research.
Positive well-being might function as a “resilient factor against depression” in autism spectrum disorder, results of a 12-month study of newly employed adults with ASD suggest.
“The potential for positive well-being to functioning as a buffer against depression in this study, as well as the broader benefits of positive well-being in the general population, suggests that positive well-being should be cultivated within the employment context,” wrote Darren Hedley, PhD, of La Trobe University, Melbourne, and his associates (Autism Res. 2019 Jan 24. doi: 10.1002/aur/2064).
To conduct the study, Dr. Hedley and his associates tested 36 (32 male) adults aged 18-57 with ASD who worked in an employment program supported by the Australian government. Among the measures used to assess mental health, social support, and job satisfaction were the Patient Health Questionnaire-9, the DSM-5 Dimensional Anxiety Scale, the Warwick-Edinburgh Mental Wellbeing Scale, the Interpersonal Support Evaluation List-12, and the Minnesota Satisfaction Questionnaire-Short Form.
Over the course of 12 months, Dr. Hedley and his associates found that the participants experienced a small increase in their daily living skills and a small drop in job satisfaction, but all other measures – except for depression – remained stable. . “These results are consistent with research in the general population that shows well-being functions as a buffer or protective factor against depression,” they wrote.
Dr. Hedley and his associates cited several limitations, including the small sample size and the absence of a comparative sample of adults with ASD engaged in open employment.
The full study can be found at Autism Research.
Positive well-being might function as a “resilient factor against depression” in autism spectrum disorder, results of a 12-month study of newly employed adults with ASD suggest.
“The potential for positive well-being to functioning as a buffer against depression in this study, as well as the broader benefits of positive well-being in the general population, suggests that positive well-being should be cultivated within the employment context,” wrote Darren Hedley, PhD, of La Trobe University, Melbourne, and his associates (Autism Res. 2019 Jan 24. doi: 10.1002/aur/2064).
To conduct the study, Dr. Hedley and his associates tested 36 (32 male) adults aged 18-57 with ASD who worked in an employment program supported by the Australian government. Among the measures used to assess mental health, social support, and job satisfaction were the Patient Health Questionnaire-9, the DSM-5 Dimensional Anxiety Scale, the Warwick-Edinburgh Mental Wellbeing Scale, the Interpersonal Support Evaluation List-12, and the Minnesota Satisfaction Questionnaire-Short Form.
Over the course of 12 months, Dr. Hedley and his associates found that the participants experienced a small increase in their daily living skills and a small drop in job satisfaction, but all other measures – except for depression – remained stable. . “These results are consistent with research in the general population that shows well-being functions as a buffer or protective factor against depression,” they wrote.
Dr. Hedley and his associates cited several limitations, including the small sample size and the absence of a comparative sample of adults with ASD engaged in open employment.
The full study can be found at Autism Research.
FDA: Clozapine REMS modified
The Food and Drug Administration has modified the Risk Evaluation and Mitigation Strategy (REMS) Program for clozapine, a second-generation antipsychotic used for patients who do not respond adequately to standard antipsychotic treatment. Use of clozapine comes with the risk of neutropenia, which can make patients vulnerable to serious infections, so routine monitoring of absolute neutrophil counts is a must.
The new requirements, including one that requires both prescribers and pharmacies to be certified in the clozapine REMS program, take effect Feb. 28.
More information about clozapine and this change can be found on the FDA web page for the drug.
The Food and Drug Administration has modified the Risk Evaluation and Mitigation Strategy (REMS) Program for clozapine, a second-generation antipsychotic used for patients who do not respond adequately to standard antipsychotic treatment. Use of clozapine comes with the risk of neutropenia, which can make patients vulnerable to serious infections, so routine monitoring of absolute neutrophil counts is a must.
The new requirements, including one that requires both prescribers and pharmacies to be certified in the clozapine REMS program, take effect Feb. 28.
More information about clozapine and this change can be found on the FDA web page for the drug.
The Food and Drug Administration has modified the Risk Evaluation and Mitigation Strategy (REMS) Program for clozapine, a second-generation antipsychotic used for patients who do not respond adequately to standard antipsychotic treatment. Use of clozapine comes with the risk of neutropenia, which can make patients vulnerable to serious infections, so routine monitoring of absolute neutrophil counts is a must.
The new requirements, including one that requires both prescribers and pharmacies to be certified in the clozapine REMS program, take effect Feb. 28.
More information about clozapine and this change can be found on the FDA web page for the drug.
Appropriate use criteria for imaging in nonvalvular heart disease released
The American College of Cardiology, the American Heart Association, and other groups have jointly released an appropriate use criteria (AUC) document regarding the use of imaging modalities in diagnosing nonvalvular (that is, structural) heart disease.
Imaging plays an important role in diagnosing both valvular and nonvalvular heart diseases, so the goal of the document was to help clinicians provide high-quality care by standardizing the decision-making process. To do so, a committee was formed to devise scenarios that reflected situations in real-world practice; these scenarios were considered within categories to prevent the list from being too exhaustive. The scenarios were then reviewed by a rating panel in terms of how appropriate certain modalities were in each situation. The panel members first evaluated the scenarios independently then face to face as a panel before giving their final scores (from 1 to 9) independently.
For example, for the indication of nonsustained ventricular tachycardia, the panelists rated transthoracic echocardiography with or without 3-D and with contrast as needed as a 8, which means it’s an “appropriate test,” whereas they gave CT for the same indication a 3, which means “rarely appropriate.” For sustained ventricular tachycardia or ventricular fibrillation, they gave a 9 and a 6, respectively; this latter score indicates the test “may be appropriate.” These scenarios and the respective scores for any given test are organized into tables, such as initial evaluation or follow-up.
This AUC document “signals a shift from documents evaluating a single modality in various disease states to documents evaluating multiple imaging modalities and focusing on evidence and clinical experience within a given disease category,” the authors wrote. “We believe this approach better reflects clinical decision making in real-world scenarios and offers the diagnostic choices available to the clinician.”
The full document can be viewed in JACC.
The American College of Cardiology, the American Heart Association, and other groups have jointly released an appropriate use criteria (AUC) document regarding the use of imaging modalities in diagnosing nonvalvular (that is, structural) heart disease.
Imaging plays an important role in diagnosing both valvular and nonvalvular heart diseases, so the goal of the document was to help clinicians provide high-quality care by standardizing the decision-making process. To do so, a committee was formed to devise scenarios that reflected situations in real-world practice; these scenarios were considered within categories to prevent the list from being too exhaustive. The scenarios were then reviewed by a rating panel in terms of how appropriate certain modalities were in each situation. The panel members first evaluated the scenarios independently then face to face as a panel before giving their final scores (from 1 to 9) independently.
For example, for the indication of nonsustained ventricular tachycardia, the panelists rated transthoracic echocardiography with or without 3-D and with contrast as needed as a 8, which means it’s an “appropriate test,” whereas they gave CT for the same indication a 3, which means “rarely appropriate.” For sustained ventricular tachycardia or ventricular fibrillation, they gave a 9 and a 6, respectively; this latter score indicates the test “may be appropriate.” These scenarios and the respective scores for any given test are organized into tables, such as initial evaluation or follow-up.
This AUC document “signals a shift from documents evaluating a single modality in various disease states to documents evaluating multiple imaging modalities and focusing on evidence and clinical experience within a given disease category,” the authors wrote. “We believe this approach better reflects clinical decision making in real-world scenarios and offers the diagnostic choices available to the clinician.”
The full document can be viewed in JACC.
The American College of Cardiology, the American Heart Association, and other groups have jointly released an appropriate use criteria (AUC) document regarding the use of imaging modalities in diagnosing nonvalvular (that is, structural) heart disease.
Imaging plays an important role in diagnosing both valvular and nonvalvular heart diseases, so the goal of the document was to help clinicians provide high-quality care by standardizing the decision-making process. To do so, a committee was formed to devise scenarios that reflected situations in real-world practice; these scenarios were considered within categories to prevent the list from being too exhaustive. The scenarios were then reviewed by a rating panel in terms of how appropriate certain modalities were in each situation. The panel members first evaluated the scenarios independently then face to face as a panel before giving their final scores (from 1 to 9) independently.
For example, for the indication of nonsustained ventricular tachycardia, the panelists rated transthoracic echocardiography with or without 3-D and with contrast as needed as a 8, which means it’s an “appropriate test,” whereas they gave CT for the same indication a 3, which means “rarely appropriate.” For sustained ventricular tachycardia or ventricular fibrillation, they gave a 9 and a 6, respectively; this latter score indicates the test “may be appropriate.” These scenarios and the respective scores for any given test are organized into tables, such as initial evaluation or follow-up.
This AUC document “signals a shift from documents evaluating a single modality in various disease states to documents evaluating multiple imaging modalities and focusing on evidence and clinical experience within a given disease category,” the authors wrote. “We believe this approach better reflects clinical decision making in real-world scenarios and offers the diagnostic choices available to the clinician.”
The full document can be viewed in JACC.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Pembrolizumab approved for Merkel cell carcinoma
The Food and Drug Administration has , specifically for recurrent locally advanced or metastatic disease.
In a nonrandomized, open-label trial of 50 patients with recurrent locally advanced or metastatic Merkel cell carcinoma who had not received systemic treatment for the advanced disease, the overall response rate was 56% with a complete response rate of 24%; median response duration was not reached. But responses lasting more than 6 months were achieved by 96% and more than 12 months by 54%. The most common adverse reactions included fatigue, musculoskeletal pain, and decreased appetite.
Because it is an accelerated approval, “continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials,” according to the FDA press release announcing the approval.
Pembrolizumab is a programmed death receptor-1 (PD-1)-blocking antibody that was previously approved for treatment of unresectable or metastatic melanoma.
More about the latest approval, as well as full prescribing information, can be found on the FDA’s website.
The Food and Drug Administration has , specifically for recurrent locally advanced or metastatic disease.
In a nonrandomized, open-label trial of 50 patients with recurrent locally advanced or metastatic Merkel cell carcinoma who had not received systemic treatment for the advanced disease, the overall response rate was 56% with a complete response rate of 24%; median response duration was not reached. But responses lasting more than 6 months were achieved by 96% and more than 12 months by 54%. The most common adverse reactions included fatigue, musculoskeletal pain, and decreased appetite.
Because it is an accelerated approval, “continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials,” according to the FDA press release announcing the approval.
Pembrolizumab is a programmed death receptor-1 (PD-1)-blocking antibody that was previously approved for treatment of unresectable or metastatic melanoma.
More about the latest approval, as well as full prescribing information, can be found on the FDA’s website.
The Food and Drug Administration has , specifically for recurrent locally advanced or metastatic disease.
In a nonrandomized, open-label trial of 50 patients with recurrent locally advanced or metastatic Merkel cell carcinoma who had not received systemic treatment for the advanced disease, the overall response rate was 56% with a complete response rate of 24%; median response duration was not reached. But responses lasting more than 6 months were achieved by 96% and more than 12 months by 54%. The most common adverse reactions included fatigue, musculoskeletal pain, and decreased appetite.
Because it is an accelerated approval, “continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials,” according to the FDA press release announcing the approval.
Pembrolizumab is a programmed death receptor-1 (PD-1)-blocking antibody that was previously approved for treatment of unresectable or metastatic melanoma.
More about the latest approval, as well as full prescribing information, can be found on the FDA’s website.
A case of cold burn reported with whole-body cryotherapy
by Mackenzie O’Connor and her colleagues in the department of dermatology and cutaneous biology at Thomas Jefferson University, Philadelphia.
In the report, they describe the case of a 71-year-old man who presented with a cold burn injury a day after a WBC session. These treatments typically involve sessions of 2-5 minutes, in a chamber that is cooled down to –100°C to –140°C.
The likely cause in this case was a nozzle malfunction that caused liquid nitrogen to come in direct contact with the patient’s skin for a prolonged period of time (less than 1 minute), causing stinging and pain, followed by redness and blistering of the skin. The patient had received four WBC treatments previously for arthritis and back pain, with no adverse effects. In addition to ibuprofen, he was treated with systemic steroids, topical corticosteroids, and silver sulfadiazine cream.
Despite claims that WBC can aid muscle recovery and alleviate joint pain, and can improve skin health, and is increasingly available in spas and other sites, the Food and Drug Administration has not approved the procedure for treatment of any medical conditions, the researchers noted (JAAD Case Rep. 2019;5[1]:29-30). They also referred to a 2015 Cochrane review, which found insufficient evidence that WBC treatment is beneficial for muscle recovery in active young adult men.
by Mackenzie O’Connor and her colleagues in the department of dermatology and cutaneous biology at Thomas Jefferson University, Philadelphia.
In the report, they describe the case of a 71-year-old man who presented with a cold burn injury a day after a WBC session. These treatments typically involve sessions of 2-5 minutes, in a chamber that is cooled down to –100°C to –140°C.
The likely cause in this case was a nozzle malfunction that caused liquid nitrogen to come in direct contact with the patient’s skin for a prolonged period of time (less than 1 minute), causing stinging and pain, followed by redness and blistering of the skin. The patient had received four WBC treatments previously for arthritis and back pain, with no adverse effects. In addition to ibuprofen, he was treated with systemic steroids, topical corticosteroids, and silver sulfadiazine cream.
Despite claims that WBC can aid muscle recovery and alleviate joint pain, and can improve skin health, and is increasingly available in spas and other sites, the Food and Drug Administration has not approved the procedure for treatment of any medical conditions, the researchers noted (JAAD Case Rep. 2019;5[1]:29-30). They also referred to a 2015 Cochrane review, which found insufficient evidence that WBC treatment is beneficial for muscle recovery in active young adult men.
by Mackenzie O’Connor and her colleagues in the department of dermatology and cutaneous biology at Thomas Jefferson University, Philadelphia.
In the report, they describe the case of a 71-year-old man who presented with a cold burn injury a day after a WBC session. These treatments typically involve sessions of 2-5 minutes, in a chamber that is cooled down to –100°C to –140°C.
The likely cause in this case was a nozzle malfunction that caused liquid nitrogen to come in direct contact with the patient’s skin for a prolonged period of time (less than 1 minute), causing stinging and pain, followed by redness and blistering of the skin. The patient had received four WBC treatments previously for arthritis and back pain, with no adverse effects. In addition to ibuprofen, he was treated with systemic steroids, topical corticosteroids, and silver sulfadiazine cream.
Despite claims that WBC can aid muscle recovery and alleviate joint pain, and can improve skin health, and is increasingly available in spas and other sites, the Food and Drug Administration has not approved the procedure for treatment of any medical conditions, the researchers noted (JAAD Case Rep. 2019;5[1]:29-30). They also referred to a 2015 Cochrane review, which found insufficient evidence that WBC treatment is beneficial for muscle recovery in active young adult men.
FROM JAAD CASE REPORTS
Self-report of prenatal marijuana use not very reliable
Even in the setting of legalized marijuana use, estimated prevalence of marijuana use during pregnancy was lower by self-report than it was by umbilical cord testing.
Torri D. Metz, MD, of the University of Utah Health, Salt Lake City, and her colleagues surveyed women at two urban hospitals in Colorado, which has legalized both medical and recreational use of marijuana. They found that, while 6% of the 116 women in the study reported using marijuana in the past 30 days, umbilical cord testing showed as many as 22% had detectable levels of 11-nor-delta-9-tetrahydrocannabinol-9-carboxylic, and 10% had levels above quantification.
The majority of studies of maternal marijuana use during pregnancy rely on self-report, so this could affect attempts to assess the effects of such prenatal use, they said.
Adverse outcomes associated with marijuana use during pregnancy include fetal growth restriction, small for gestational age, preterm birth, and adverse neurodevelopmental outcomes, studies have shown.
Read more in Obstetrics & Gynecology.
Even in the setting of legalized marijuana use, estimated prevalence of marijuana use during pregnancy was lower by self-report than it was by umbilical cord testing.
Torri D. Metz, MD, of the University of Utah Health, Salt Lake City, and her colleagues surveyed women at two urban hospitals in Colorado, which has legalized both medical and recreational use of marijuana. They found that, while 6% of the 116 women in the study reported using marijuana in the past 30 days, umbilical cord testing showed as many as 22% had detectable levels of 11-nor-delta-9-tetrahydrocannabinol-9-carboxylic, and 10% had levels above quantification.
The majority of studies of maternal marijuana use during pregnancy rely on self-report, so this could affect attempts to assess the effects of such prenatal use, they said.
Adverse outcomes associated with marijuana use during pregnancy include fetal growth restriction, small for gestational age, preterm birth, and adverse neurodevelopmental outcomes, studies have shown.
Read more in Obstetrics & Gynecology.
Even in the setting of legalized marijuana use, estimated prevalence of marijuana use during pregnancy was lower by self-report than it was by umbilical cord testing.
Torri D. Metz, MD, of the University of Utah Health, Salt Lake City, and her colleagues surveyed women at two urban hospitals in Colorado, which has legalized both medical and recreational use of marijuana. They found that, while 6% of the 116 women in the study reported using marijuana in the past 30 days, umbilical cord testing showed as many as 22% had detectable levels of 11-nor-delta-9-tetrahydrocannabinol-9-carboxylic, and 10% had levels above quantification.
The majority of studies of maternal marijuana use during pregnancy rely on self-report, so this could affect attempts to assess the effects of such prenatal use, they said.
Adverse outcomes associated with marijuana use during pregnancy include fetal growth restriction, small for gestational age, preterm birth, and adverse neurodevelopmental outcomes, studies have shown.
Read more in Obstetrics & Gynecology.
FROM OBSTETRICS & GYNECOLOGY
Phase 3 study of novel pemphigus treatment is initiated
and will enroll about 120 patients with moderate to severe disease, according to Principia Biopharma, which is developing the drug.
In a press release, the company said that the randomized, double-blind PEGASYS study will compare PRN1008 with placebo, in about 120 patients with newly diagnosed or relapsing moderate to severe pemphigus.
The company also reported the results of an open label phase 2 study of patients with newly diagnosed or relapsing mild or moderate pemphigus, including pemphigus vulgaris and pemphigus foliaceus, which found that control of disease activity within 4 weeks of starting treatment – the primary efficacy endpoint – was achieved by more than 50% of patients taking PRN1008. Principia has extended the trial’s active treatment period from 12 to 24 weeks. The results also led the company to initiate the phase 3 trial.
PRN1008 is an inhibitor of BTK, an enzyme that “is present in the signaling pathways of most types of white blood cells except for T cells and plasma cells,” according to the company’s press release.
and will enroll about 120 patients with moderate to severe disease, according to Principia Biopharma, which is developing the drug.
In a press release, the company said that the randomized, double-blind PEGASYS study will compare PRN1008 with placebo, in about 120 patients with newly diagnosed or relapsing moderate to severe pemphigus.
The company also reported the results of an open label phase 2 study of patients with newly diagnosed or relapsing mild or moderate pemphigus, including pemphigus vulgaris and pemphigus foliaceus, which found that control of disease activity within 4 weeks of starting treatment – the primary efficacy endpoint – was achieved by more than 50% of patients taking PRN1008. Principia has extended the trial’s active treatment period from 12 to 24 weeks. The results also led the company to initiate the phase 3 trial.
PRN1008 is an inhibitor of BTK, an enzyme that “is present in the signaling pathways of most types of white blood cells except for T cells and plasma cells,” according to the company’s press release.
and will enroll about 120 patients with moderate to severe disease, according to Principia Biopharma, which is developing the drug.
In a press release, the company said that the randomized, double-blind PEGASYS study will compare PRN1008 with placebo, in about 120 patients with newly diagnosed or relapsing moderate to severe pemphigus.
The company also reported the results of an open label phase 2 study of patients with newly diagnosed or relapsing mild or moderate pemphigus, including pemphigus vulgaris and pemphigus foliaceus, which found that control of disease activity within 4 weeks of starting treatment – the primary efficacy endpoint – was achieved by more than 50% of patients taking PRN1008. Principia has extended the trial’s active treatment period from 12 to 24 weeks. The results also led the company to initiate the phase 3 trial.
PRN1008 is an inhibitor of BTK, an enzyme that “is present in the signaling pathways of most types of white blood cells except for T cells and plasma cells,” according to the company’s press release.