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Janssen seeks approval for split dosing of daratumumab
Janssen has applied to the Food and Drug Administration and the European Medicines Agency to allow splitting of the first infusion of daratumumab (Darzalex) in multiple myeloma patients over 2 consecutive days.
The goal is to improve the treatment experience for patients and physicians, according to the announcement from Janssen.
The regulatory submissions are based on the global, multi-arm, phase 1b MMY1001 study (NCT01998971). The study evaluated daratumumab in combination with various other treatments in 240 patients with multiple myeloma. It found that both the safety profile and the pharmacokinetics concentrations seen with either single dosing or split dosing were similar.
Daratumumab is the first approved monoclonal antibody that targets CD38, which is expressed across multiple myeloma cells regardless of disease stage. Daratumumab is currently approved for treatment of multiple myeloma in both the United States and the European Union either as monotherapy or in conjunction with other treatments.
Daratumumab is known to sometimes cause severe/serious infusion reactions, such as anaphylactic reactions; interfere with serological testing; and cause neutropenia or thrombocytopenia.
Janssen has applied to the Food and Drug Administration and the European Medicines Agency to allow splitting of the first infusion of daratumumab (Darzalex) in multiple myeloma patients over 2 consecutive days.
The goal is to improve the treatment experience for patients and physicians, according to the announcement from Janssen.
The regulatory submissions are based on the global, multi-arm, phase 1b MMY1001 study (NCT01998971). The study evaluated daratumumab in combination with various other treatments in 240 patients with multiple myeloma. It found that both the safety profile and the pharmacokinetics concentrations seen with either single dosing or split dosing were similar.
Daratumumab is the first approved monoclonal antibody that targets CD38, which is expressed across multiple myeloma cells regardless of disease stage. Daratumumab is currently approved for treatment of multiple myeloma in both the United States and the European Union either as monotherapy or in conjunction with other treatments.
Daratumumab is known to sometimes cause severe/serious infusion reactions, such as anaphylactic reactions; interfere with serological testing; and cause neutropenia or thrombocytopenia.
Janssen has applied to the Food and Drug Administration and the European Medicines Agency to allow splitting of the first infusion of daratumumab (Darzalex) in multiple myeloma patients over 2 consecutive days.
The goal is to improve the treatment experience for patients and physicians, according to the announcement from Janssen.
The regulatory submissions are based on the global, multi-arm, phase 1b MMY1001 study (NCT01998971). The study evaluated daratumumab in combination with various other treatments in 240 patients with multiple myeloma. It found that both the safety profile and the pharmacokinetics concentrations seen with either single dosing or split dosing were similar.
Daratumumab is the first approved monoclonal antibody that targets CD38, which is expressed across multiple myeloma cells regardless of disease stage. Daratumumab is currently approved for treatment of multiple myeloma in both the United States and the European Union either as monotherapy or in conjunction with other treatments.
Daratumumab is known to sometimes cause severe/serious infusion reactions, such as anaphylactic reactions; interfere with serological testing; and cause neutropenia or thrombocytopenia.
ASCO calls for expanding clinical trial eligibility
The American Society of Clinical Oncology and Friends of Cancer Research have submitted recommended language to the Food and Drug Administration for ways to expand eligibility criteria for cancer clinical trials.
The recommendations address five specific areas that were identified as most likely to restrict participation, but least likely to affect the safety of participants, and include minimum age requirements for trial enrollment, HIV/AIDS status, brain metastases, organ dysfunction, and prior and concurrent malignancies.
“Eligibility criteria ensure patient safety, but if they are overly strict, they can jeopardize accrual for clinical trials and reduce the ability to apply trial results to treating patients with cancer in clinical practice,” ASCO President Monica M. Bertagnolli, MD, said in a statement. “These guidance documents help trial sponsors understand how to modernize eligibility criteria and ensure that trial participants more accurately reflect the patients who will receive a drug after approval.”
The two organizations launched an effort to update clinical trial eligibility criteria in 2016 and published a joint statement in 2017. The letter to the FDA and the rationale and instructions for expanding eligibility criteria in each of the five areas can be found here on the Friends of Cancer Research website.
SOURCE: Friends of Cancer and ASCO letter to the FDA.
The American Society of Clinical Oncology and Friends of Cancer Research have submitted recommended language to the Food and Drug Administration for ways to expand eligibility criteria for cancer clinical trials.
The recommendations address five specific areas that were identified as most likely to restrict participation, but least likely to affect the safety of participants, and include minimum age requirements for trial enrollment, HIV/AIDS status, brain metastases, organ dysfunction, and prior and concurrent malignancies.
“Eligibility criteria ensure patient safety, but if they are overly strict, they can jeopardize accrual for clinical trials and reduce the ability to apply trial results to treating patients with cancer in clinical practice,” ASCO President Monica M. Bertagnolli, MD, said in a statement. “These guidance documents help trial sponsors understand how to modernize eligibility criteria and ensure that trial participants more accurately reflect the patients who will receive a drug after approval.”
The two organizations launched an effort to update clinical trial eligibility criteria in 2016 and published a joint statement in 2017. The letter to the FDA and the rationale and instructions for expanding eligibility criteria in each of the five areas can be found here on the Friends of Cancer Research website.
SOURCE: Friends of Cancer and ASCO letter to the FDA.
The American Society of Clinical Oncology and Friends of Cancer Research have submitted recommended language to the Food and Drug Administration for ways to expand eligibility criteria for cancer clinical trials.
The recommendations address five specific areas that were identified as most likely to restrict participation, but least likely to affect the safety of participants, and include minimum age requirements for trial enrollment, HIV/AIDS status, brain metastases, organ dysfunction, and prior and concurrent malignancies.
“Eligibility criteria ensure patient safety, but if they are overly strict, they can jeopardize accrual for clinical trials and reduce the ability to apply trial results to treating patients with cancer in clinical practice,” ASCO President Monica M. Bertagnolli, MD, said in a statement. “These guidance documents help trial sponsors understand how to modernize eligibility criteria and ensure that trial participants more accurately reflect the patients who will receive a drug after approval.”
The two organizations launched an effort to update clinical trial eligibility criteria in 2016 and published a joint statement in 2017. The letter to the FDA and the rationale and instructions for expanding eligibility criteria in each of the five areas can be found here on the Friends of Cancer Research website.
SOURCE: Friends of Cancer and ASCO letter to the FDA.
Key clinical point: ASCO and Friends of Cancer have submitted draft recommendations to the FDA for expanding cancer clinical trial participation.
Major finding: The organizations recommend addressing minimum age requirements, HIV/AIDS status, brain metastases, organ dysfunction, and prior and concurrent malignancies.
Data source: Draft guidance produced by ASCO and Friends of Cancer Research and submitted to the FDA.
Disclosures: Individual members of the working groups were not listed and conflicts of interest were not disclosed.
Source: Friends of Cancer and ASCO letter to the FDA.
FDA approves biologic for mycosis fungoides, Sézary syndrome
The Food and Drug Administration has approved mogamulizumab-kpkc (Poteligeo) for the treatment of adults with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.
Mogamulizumab is a humanized monoclonal antibody directed against CC chemokine receptor 4 (CCR4). It is the first biologic agent targeting CCR4 to be approved for patients in the United States.
Mogamulizumab is expected to be commercially available in the fourth quarter of 2018.
The FDA previously granted mogamulizumab breakthrough therapy and orphan drug designations, as well as priority review.
The approval is supported by the phase 3 MAVORIC trial. Results from this trial were presented at the 10th Annual T-cell Lymphoma Forum in February 2018.
MAVORIC enrolled 372 adults with histologically confirmed MF or SS who had failed at least one systemic therapy. They were randomized to receive mogamulizumab at 1.0 mg/kg (weekly for the first 4-week cycle and then every 2 weeks) or vorinostat at 400 mg daily. Patients were treated until disease progression or unacceptable toxicity. Those receiving vorinostat could cross over to mogamulizumab if they progressed or experienced intolerable toxicity. Baseline characteristics were similar between the treatment arms. The study’s primary endpoint was progression-free survival. The median progression-free survival was 7.7 months with mogamulizumab and 3.1 months with vorinostat (hazard ratio, 0.53; P less than .0001).
The global overall response rate was 28% (52/189) in the mogamulizumab arm and 5% (9/186) in the vorinostat arm (P less than .0001). For patients with MF, the ORR was 21% with mogamulizumab and 7% with vorinostat; for patients with SS, the ORR was 37% and 2%, respectively. After crossover, the ORR in the mogamulizumab arm was 30% (41/136).
The median duration of response (DOR) was 14 months in the mogamulizumab arm and 9 months in the vorinostat arm. For MF patients, the median DOR was 13 months with mogamulizumab and 9 months with vorinostat; for SS patients, the median DOR was 17 months and 7 months, respectively.
The most common treatment-emergent adverse events (AEs), which occurred in at least 20% of patients in either arm (mogamulizumab and vorinostat, respectively), included the following:
- Infusion-related reactions (33.2% vs. 0.5%).
- Drug eruptions (23.9% vs. 0.5%).
- Diarrhea (23.4% vs. 61.8%).
- Nausea (15.2% vs. 42.5%).
- Thrombocytopenia (11.4% vs. 30.6%).
- Dysgeusia (3.3% vs. 28.0%).
- Increased blood creatinine (3.3% vs. 28.0%).
- Decreased appetite (7.6% vs. 24.7%).
There were no grade 4 AEs in the mogamulizumab arm. Grade 3 AEs in mogamulizumab recipients included drug eruptions (n = 8), infusion-related reactions (n = 3), fatigue (n = 3), decreased appetite (n = 2), nausea (n = 1), pyrexia (n = 1), and diarrhea (n = 1).
The drug is marketed by Kyowa Kirin.
The Food and Drug Administration has approved mogamulizumab-kpkc (Poteligeo) for the treatment of adults with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.
Mogamulizumab is a humanized monoclonal antibody directed against CC chemokine receptor 4 (CCR4). It is the first biologic agent targeting CCR4 to be approved for patients in the United States.
Mogamulizumab is expected to be commercially available in the fourth quarter of 2018.
The FDA previously granted mogamulizumab breakthrough therapy and orphan drug designations, as well as priority review.
The approval is supported by the phase 3 MAVORIC trial. Results from this trial were presented at the 10th Annual T-cell Lymphoma Forum in February 2018.
MAVORIC enrolled 372 adults with histologically confirmed MF or SS who had failed at least one systemic therapy. They were randomized to receive mogamulizumab at 1.0 mg/kg (weekly for the first 4-week cycle and then every 2 weeks) or vorinostat at 400 mg daily. Patients were treated until disease progression or unacceptable toxicity. Those receiving vorinostat could cross over to mogamulizumab if they progressed or experienced intolerable toxicity. Baseline characteristics were similar between the treatment arms. The study’s primary endpoint was progression-free survival. The median progression-free survival was 7.7 months with mogamulizumab and 3.1 months with vorinostat (hazard ratio, 0.53; P less than .0001).
The global overall response rate was 28% (52/189) in the mogamulizumab arm and 5% (9/186) in the vorinostat arm (P less than .0001). For patients with MF, the ORR was 21% with mogamulizumab and 7% with vorinostat; for patients with SS, the ORR was 37% and 2%, respectively. After crossover, the ORR in the mogamulizumab arm was 30% (41/136).
The median duration of response (DOR) was 14 months in the mogamulizumab arm and 9 months in the vorinostat arm. For MF patients, the median DOR was 13 months with mogamulizumab and 9 months with vorinostat; for SS patients, the median DOR was 17 months and 7 months, respectively.
The most common treatment-emergent adverse events (AEs), which occurred in at least 20% of patients in either arm (mogamulizumab and vorinostat, respectively), included the following:
- Infusion-related reactions (33.2% vs. 0.5%).
- Drug eruptions (23.9% vs. 0.5%).
- Diarrhea (23.4% vs. 61.8%).
- Nausea (15.2% vs. 42.5%).
- Thrombocytopenia (11.4% vs. 30.6%).
- Dysgeusia (3.3% vs. 28.0%).
- Increased blood creatinine (3.3% vs. 28.0%).
- Decreased appetite (7.6% vs. 24.7%).
There were no grade 4 AEs in the mogamulizumab arm. Grade 3 AEs in mogamulizumab recipients included drug eruptions (n = 8), infusion-related reactions (n = 3), fatigue (n = 3), decreased appetite (n = 2), nausea (n = 1), pyrexia (n = 1), and diarrhea (n = 1).
The drug is marketed by Kyowa Kirin.
The Food and Drug Administration has approved mogamulizumab-kpkc (Poteligeo) for the treatment of adults with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.
Mogamulizumab is a humanized monoclonal antibody directed against CC chemokine receptor 4 (CCR4). It is the first biologic agent targeting CCR4 to be approved for patients in the United States.
Mogamulizumab is expected to be commercially available in the fourth quarter of 2018.
The FDA previously granted mogamulizumab breakthrough therapy and orphan drug designations, as well as priority review.
The approval is supported by the phase 3 MAVORIC trial. Results from this trial were presented at the 10th Annual T-cell Lymphoma Forum in February 2018.
MAVORIC enrolled 372 adults with histologically confirmed MF or SS who had failed at least one systemic therapy. They were randomized to receive mogamulizumab at 1.0 mg/kg (weekly for the first 4-week cycle and then every 2 weeks) or vorinostat at 400 mg daily. Patients were treated until disease progression or unacceptable toxicity. Those receiving vorinostat could cross over to mogamulizumab if they progressed or experienced intolerable toxicity. Baseline characteristics were similar between the treatment arms. The study’s primary endpoint was progression-free survival. The median progression-free survival was 7.7 months with mogamulizumab and 3.1 months with vorinostat (hazard ratio, 0.53; P less than .0001).
The global overall response rate was 28% (52/189) in the mogamulizumab arm and 5% (9/186) in the vorinostat arm (P less than .0001). For patients with MF, the ORR was 21% with mogamulizumab and 7% with vorinostat; for patients with SS, the ORR was 37% and 2%, respectively. After crossover, the ORR in the mogamulizumab arm was 30% (41/136).
The median duration of response (DOR) was 14 months in the mogamulizumab arm and 9 months in the vorinostat arm. For MF patients, the median DOR was 13 months with mogamulizumab and 9 months with vorinostat; for SS patients, the median DOR was 17 months and 7 months, respectively.
The most common treatment-emergent adverse events (AEs), which occurred in at least 20% of patients in either arm (mogamulizumab and vorinostat, respectively), included the following:
- Infusion-related reactions (33.2% vs. 0.5%).
- Drug eruptions (23.9% vs. 0.5%).
- Diarrhea (23.4% vs. 61.8%).
- Nausea (15.2% vs. 42.5%).
- Thrombocytopenia (11.4% vs. 30.6%).
- Dysgeusia (3.3% vs. 28.0%).
- Increased blood creatinine (3.3% vs. 28.0%).
- Decreased appetite (7.6% vs. 24.7%).
There were no grade 4 AEs in the mogamulizumab arm. Grade 3 AEs in mogamulizumab recipients included drug eruptions (n = 8), infusion-related reactions (n = 3), fatigue (n = 3), decreased appetite (n = 2), nausea (n = 1), pyrexia (n = 1), and diarrhea (n = 1).
The drug is marketed by Kyowa Kirin.
1 in 7 Zika-exposed babies have at least one health problem related to the virus
About 14% of 1-year-olds with prenatal Zika virus exposure show at least one health problem probably related to the virus, according to a study published in Morbidity and Mortality Weekly Report.
Many of the problems are brain and eye abnormalities, which occurred at 30 times the 0.16% background rate among unexposed babies, Margaret Honein, PhD, and colleagues reported.
In a press briefing, Dr. Honein, chief of the Birth Defects Branch at the National Center on Birth Defects and Developmental Disabilities, described findings from the U.S. Zika Pregnancy and Infant Registry (USZPIR).
“Today’s report is the largest to date with long-term outcomes of babies born to mothers with [lab-confirmed] Zika infections, and the first published data on children 1 year or older from the ongoing surveillance network,” Dr. Honein said. It “clearly shows that the Zika story is not over, especially for the children and families who are affected by it.”
USZPIR is monitoring the outcomes of 7,300 pregnancies with lab-confirmed Zika infection. From these, 4,800 babies were born in the U.S. territories and freely associated states, had reached the age of 1 year by Feb. 1, 2018, and were included in the study.
In addition to clinical outcomes, the investigators looked at how many babies received the recommended evaluations, including neuroimaging, hearing screens, opthalmologic exams, developmental screening, and physical exams.
Almost all (95%) had at least one exam in the first 2 weeks of life; 76% had at least one developmental screening; 60% had postnatal neuroimaging; 48% at least one hearing exam; and 36% at least one eye exam by a specialist, the investigators found.
Findings that many didn’t get all the recommended health screenings are concerning, CDC Director Robert Redfield, MD. said during the briefing. “We are still learning about the full range of long-term health problems these babies could face. We thank clinicians for their continued commitment to conduct all necessary tests and evaluations to ensure appropriate care.”
Zika-associated birth defects occurred 203 babies (14%). Another 136 (9%) had at least one neurodevelopmental abnormality possibly associated with congenital Zika virus infection, and 20 (1%) had both. Most babies (1,386; 96%) did not have microcephaly detected at birth. But there was some “misclassification” of the condition, the investigators found. “Five infants had microcephaly at birth with brain or eye anomalies identified at birth; 59 had microcephaly at birth with no brain or eye anomalies identified at birth; and 20 infants did not have microcephaly identified at birth but had postnatal identification of microcephaly.”
Neurodevelopmental abnormalities possibly associated with Zika occurred in 136 (9%) of the cohort; 116 (8%) had no Zika-associated birth defects. Among these, half (58) had only possible developmental delay.
Zika transmission appears to be slowing, Lyle Peterson, MD, said during the press briefing, with no cases in the continental U.S. since 2017. That year, there were two cases in Florida and five in Texas. However, it is now endemic in many regions. Everyone should continue to take precautions against mosquito bites, he urged.
The MMWR also included updated guidance for men who are planning a pregnancy with a partner and may have been exposed to Zika.
CDC now recommends that these men wait at least 3 months after onset of Zika symptoms or any possible exposure, including travel to or living in a risk area. Past guidance recommended a 6-month waiting period. The new recommendation reflects emerging data suggesting that the risk of infectious Zika in semen declines during the 3 months after symptom onset.
Men who want to avoid passing Zika through sex should abstain for 3 months, or use a condom every time they have sex, the new recommendation said.
“All other Zika guidance remains unchanged,” the guidelines note. “Men with possible Zika virus exposure whose partner is pregnant should use condoms or the couple should not have sex for the entire pregnancy to reduce the risk of transmission.”
SOURCE: Honein, MA et al. MMWR 2018; 67: 1-10.
About 14% of 1-year-olds with prenatal Zika virus exposure show at least one health problem probably related to the virus, according to a study published in Morbidity and Mortality Weekly Report.
Many of the problems are brain and eye abnormalities, which occurred at 30 times the 0.16% background rate among unexposed babies, Margaret Honein, PhD, and colleagues reported.
In a press briefing, Dr. Honein, chief of the Birth Defects Branch at the National Center on Birth Defects and Developmental Disabilities, described findings from the U.S. Zika Pregnancy and Infant Registry (USZPIR).
“Today’s report is the largest to date with long-term outcomes of babies born to mothers with [lab-confirmed] Zika infections, and the first published data on children 1 year or older from the ongoing surveillance network,” Dr. Honein said. It “clearly shows that the Zika story is not over, especially for the children and families who are affected by it.”
USZPIR is monitoring the outcomes of 7,300 pregnancies with lab-confirmed Zika infection. From these, 4,800 babies were born in the U.S. territories and freely associated states, had reached the age of 1 year by Feb. 1, 2018, and were included in the study.
In addition to clinical outcomes, the investigators looked at how many babies received the recommended evaluations, including neuroimaging, hearing screens, opthalmologic exams, developmental screening, and physical exams.
Almost all (95%) had at least one exam in the first 2 weeks of life; 76% had at least one developmental screening; 60% had postnatal neuroimaging; 48% at least one hearing exam; and 36% at least one eye exam by a specialist, the investigators found.
Findings that many didn’t get all the recommended health screenings are concerning, CDC Director Robert Redfield, MD. said during the briefing. “We are still learning about the full range of long-term health problems these babies could face. We thank clinicians for their continued commitment to conduct all necessary tests and evaluations to ensure appropriate care.”
Zika-associated birth defects occurred 203 babies (14%). Another 136 (9%) had at least one neurodevelopmental abnormality possibly associated with congenital Zika virus infection, and 20 (1%) had both. Most babies (1,386; 96%) did not have microcephaly detected at birth. But there was some “misclassification” of the condition, the investigators found. “Five infants had microcephaly at birth with brain or eye anomalies identified at birth; 59 had microcephaly at birth with no brain or eye anomalies identified at birth; and 20 infants did not have microcephaly identified at birth but had postnatal identification of microcephaly.”
Neurodevelopmental abnormalities possibly associated with Zika occurred in 136 (9%) of the cohort; 116 (8%) had no Zika-associated birth defects. Among these, half (58) had only possible developmental delay.
Zika transmission appears to be slowing, Lyle Peterson, MD, said during the press briefing, with no cases in the continental U.S. since 2017. That year, there were two cases in Florida and five in Texas. However, it is now endemic in many regions. Everyone should continue to take precautions against mosquito bites, he urged.
The MMWR also included updated guidance for men who are planning a pregnancy with a partner and may have been exposed to Zika.
CDC now recommends that these men wait at least 3 months after onset of Zika symptoms or any possible exposure, including travel to or living in a risk area. Past guidance recommended a 6-month waiting period. The new recommendation reflects emerging data suggesting that the risk of infectious Zika in semen declines during the 3 months after symptom onset.
Men who want to avoid passing Zika through sex should abstain for 3 months, or use a condom every time they have sex, the new recommendation said.
“All other Zika guidance remains unchanged,” the guidelines note. “Men with possible Zika virus exposure whose partner is pregnant should use condoms or the couple should not have sex for the entire pregnancy to reduce the risk of transmission.”
SOURCE: Honein, MA et al. MMWR 2018; 67: 1-10.
About 14% of 1-year-olds with prenatal Zika virus exposure show at least one health problem probably related to the virus, according to a study published in Morbidity and Mortality Weekly Report.
Many of the problems are brain and eye abnormalities, which occurred at 30 times the 0.16% background rate among unexposed babies, Margaret Honein, PhD, and colleagues reported.
In a press briefing, Dr. Honein, chief of the Birth Defects Branch at the National Center on Birth Defects and Developmental Disabilities, described findings from the U.S. Zika Pregnancy and Infant Registry (USZPIR).
“Today’s report is the largest to date with long-term outcomes of babies born to mothers with [lab-confirmed] Zika infections, and the first published data on children 1 year or older from the ongoing surveillance network,” Dr. Honein said. It “clearly shows that the Zika story is not over, especially for the children and families who are affected by it.”
USZPIR is monitoring the outcomes of 7,300 pregnancies with lab-confirmed Zika infection. From these, 4,800 babies were born in the U.S. territories and freely associated states, had reached the age of 1 year by Feb. 1, 2018, and were included in the study.
In addition to clinical outcomes, the investigators looked at how many babies received the recommended evaluations, including neuroimaging, hearing screens, opthalmologic exams, developmental screening, and physical exams.
Almost all (95%) had at least one exam in the first 2 weeks of life; 76% had at least one developmental screening; 60% had postnatal neuroimaging; 48% at least one hearing exam; and 36% at least one eye exam by a specialist, the investigators found.
Findings that many didn’t get all the recommended health screenings are concerning, CDC Director Robert Redfield, MD. said during the briefing. “We are still learning about the full range of long-term health problems these babies could face. We thank clinicians for their continued commitment to conduct all necessary tests and evaluations to ensure appropriate care.”
Zika-associated birth defects occurred 203 babies (14%). Another 136 (9%) had at least one neurodevelopmental abnormality possibly associated with congenital Zika virus infection, and 20 (1%) had both. Most babies (1,386; 96%) did not have microcephaly detected at birth. But there was some “misclassification” of the condition, the investigators found. “Five infants had microcephaly at birth with brain or eye anomalies identified at birth; 59 had microcephaly at birth with no brain or eye anomalies identified at birth; and 20 infants did not have microcephaly identified at birth but had postnatal identification of microcephaly.”
Neurodevelopmental abnormalities possibly associated with Zika occurred in 136 (9%) of the cohort; 116 (8%) had no Zika-associated birth defects. Among these, half (58) had only possible developmental delay.
Zika transmission appears to be slowing, Lyle Peterson, MD, said during the press briefing, with no cases in the continental U.S. since 2017. That year, there were two cases in Florida and five in Texas. However, it is now endemic in many regions. Everyone should continue to take precautions against mosquito bites, he urged.
The MMWR also included updated guidance for men who are planning a pregnancy with a partner and may have been exposed to Zika.
CDC now recommends that these men wait at least 3 months after onset of Zika symptoms or any possible exposure, including travel to or living in a risk area. Past guidance recommended a 6-month waiting period. The new recommendation reflects emerging data suggesting that the risk of infectious Zika in semen declines during the 3 months after symptom onset.
Men who want to avoid passing Zika through sex should abstain for 3 months, or use a condom every time they have sex, the new recommendation said.
“All other Zika guidance remains unchanged,” the guidelines note. “Men with possible Zika virus exposure whose partner is pregnant should use condoms or the couple should not have sex for the entire pregnancy to reduce the risk of transmission.”
SOURCE: Honein, MA et al. MMWR 2018; 67: 1-10.
FROM MMWR
Key clinical point: Zika-related health problems are present in a substantial number of prenatally exposed babies.
Major finding: Problems occurred in 14% of 4,800 included in a national registry.
Study details: USZPIR is monitoring the outcomes of 7,300 pregnancies with lab-confirmed Zika infection. Disclosures: No relevant conflicts of interest were disclosed.
Source: Honein, MA et al. MMWR 2018; 67: 1-10.
FDA proposes broader outcomes for OUD treatment drug approvals
Manufacturers developing the next generation of drugs to help combat opioid use disorder could have a broader set of outcome measures to target when bringing their products before the Food and Drug Administration for approval.
Traditionally, the FDA has used a reduction in drug-taking behavior as the endpoint for approving a medication-assisted treatment to combat opioid use disorder. But a draft guidance issued Aug. 6 could change that.
The guidance, “Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment,” proposes numerous clinical endpoints, including reduction in adverse outcomes of opioid use disorder, (for example, mortality, the need for emergency medical interventions, or hepatitis C seroconversion); change in the disease status using diagnostic criteria for opioid use disorder; development of patient-reported outcome measures; or changes in drug use patterns other than the commonly used endpoint of abstinence.
, such as the ability to resume work or school.
“The evidence is clear. Medication-assisted treatment works, and it is a key piece of defeating the drug crisis facing our country,” Department of Health and Human Services Secretary Alex Azar said in a statement. He added that the new guidance has “the potential to bring new medications to market that are more closely tailored to patient needs and help give Americans facing addiction a better change at recovery.”
FDA Commissioner Scott Gottlieb, MD, added in the statement: “We must consider new ways to gauge success beyond simply whether a patient in recovery has stopped using opioids, such as reducing relapse overdoses and infectious disease transmission. Treatments that can impact these aspects of addiction can be important parts of a comprehensive approach to the treatment of opioid use disorder.”
Guidance comments are due Oct. 9 and can be submitted online here.
Manufacturers developing the next generation of drugs to help combat opioid use disorder could have a broader set of outcome measures to target when bringing their products before the Food and Drug Administration for approval.
Traditionally, the FDA has used a reduction in drug-taking behavior as the endpoint for approving a medication-assisted treatment to combat opioid use disorder. But a draft guidance issued Aug. 6 could change that.
The guidance, “Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment,” proposes numerous clinical endpoints, including reduction in adverse outcomes of opioid use disorder, (for example, mortality, the need for emergency medical interventions, or hepatitis C seroconversion); change in the disease status using diagnostic criteria for opioid use disorder; development of patient-reported outcome measures; or changes in drug use patterns other than the commonly used endpoint of abstinence.
, such as the ability to resume work or school.
“The evidence is clear. Medication-assisted treatment works, and it is a key piece of defeating the drug crisis facing our country,” Department of Health and Human Services Secretary Alex Azar said in a statement. He added that the new guidance has “the potential to bring new medications to market that are more closely tailored to patient needs and help give Americans facing addiction a better change at recovery.”
FDA Commissioner Scott Gottlieb, MD, added in the statement: “We must consider new ways to gauge success beyond simply whether a patient in recovery has stopped using opioids, such as reducing relapse overdoses and infectious disease transmission. Treatments that can impact these aspects of addiction can be important parts of a comprehensive approach to the treatment of opioid use disorder.”
Guidance comments are due Oct. 9 and can be submitted online here.
Manufacturers developing the next generation of drugs to help combat opioid use disorder could have a broader set of outcome measures to target when bringing their products before the Food and Drug Administration for approval.
Traditionally, the FDA has used a reduction in drug-taking behavior as the endpoint for approving a medication-assisted treatment to combat opioid use disorder. But a draft guidance issued Aug. 6 could change that.
The guidance, “Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment,” proposes numerous clinical endpoints, including reduction in adverse outcomes of opioid use disorder, (for example, mortality, the need for emergency medical interventions, or hepatitis C seroconversion); change in the disease status using diagnostic criteria for opioid use disorder; development of patient-reported outcome measures; or changes in drug use patterns other than the commonly used endpoint of abstinence.
, such as the ability to resume work or school.
“The evidence is clear. Medication-assisted treatment works, and it is a key piece of defeating the drug crisis facing our country,” Department of Health and Human Services Secretary Alex Azar said in a statement. He added that the new guidance has “the potential to bring new medications to market that are more closely tailored to patient needs and help give Americans facing addiction a better change at recovery.”
FDA Commissioner Scott Gottlieb, MD, added in the statement: “We must consider new ways to gauge success beyond simply whether a patient in recovery has stopped using opioids, such as reducing relapse overdoses and infectious disease transmission. Treatments that can impact these aspects of addiction can be important parts of a comprehensive approach to the treatment of opioid use disorder.”
Guidance comments are due Oct. 9 and can be submitted online here.
FDA warns against azithromycin in blood or lymph node cancers
The Food and Drug Administration has issued a in patients with blood or lymph node cancers who have received donor stem cell transplants.
This use of azithromycin can lead to increased risk of cancer relapse and death in this population. The FDA is continuing to review data and is expected to issue further recommendations.
Patients with blood or lymph node cancers are at an increased risk of bronchiolitis obliterans syndrome after donor stem cell transplant; although azithromycin is not approved for prevention of this condition, the antibiotic is sometimes prescribed for that purpose.
A French study of 480 patients was undertaken to assess the effectiveness of this prophylaxis but revealed the increased risk of relapse and death and was halted 13 months after completing enrollment. The rate of cancer relapse was 32.9% in the azithromycin group and just 20.8% in the placebo group; the 2-year survival rate was 56.6% in the azithromycin group and 70.1% in the placebo group (JAMA 2017;318[6]:557-66).
Bronchiolitis obliterans syndrome is marked by inflammation and scarring of the airways that leads to severe shortness of breath and dry cough. There are no known effective antibiotic treatments for prophylaxis of the condition, according to the FDA.
FDA officials are advising physicians not to prescribe long-term azithromycin in this population. Patients who have had a stem cell transplant and are already taking the antibiotic, should consult a doctor before discontinuing.
The manufacturer of brand name azithromycin (Zithromax) has issued a Dear Healthcare Provider letter about the safety issue, and more information can be found in the FDA’s safety announcement.
The Food and Drug Administration has issued a in patients with blood or lymph node cancers who have received donor stem cell transplants.
This use of azithromycin can lead to increased risk of cancer relapse and death in this population. The FDA is continuing to review data and is expected to issue further recommendations.
Patients with blood or lymph node cancers are at an increased risk of bronchiolitis obliterans syndrome after donor stem cell transplant; although azithromycin is not approved for prevention of this condition, the antibiotic is sometimes prescribed for that purpose.
A French study of 480 patients was undertaken to assess the effectiveness of this prophylaxis but revealed the increased risk of relapse and death and was halted 13 months after completing enrollment. The rate of cancer relapse was 32.9% in the azithromycin group and just 20.8% in the placebo group; the 2-year survival rate was 56.6% in the azithromycin group and 70.1% in the placebo group (JAMA 2017;318[6]:557-66).
Bronchiolitis obliterans syndrome is marked by inflammation and scarring of the airways that leads to severe shortness of breath and dry cough. There are no known effective antibiotic treatments for prophylaxis of the condition, according to the FDA.
FDA officials are advising physicians not to prescribe long-term azithromycin in this population. Patients who have had a stem cell transplant and are already taking the antibiotic, should consult a doctor before discontinuing.
The manufacturer of brand name azithromycin (Zithromax) has issued a Dear Healthcare Provider letter about the safety issue, and more information can be found in the FDA’s safety announcement.
The Food and Drug Administration has issued a in patients with blood or lymph node cancers who have received donor stem cell transplants.
This use of azithromycin can lead to increased risk of cancer relapse and death in this population. The FDA is continuing to review data and is expected to issue further recommendations.
Patients with blood or lymph node cancers are at an increased risk of bronchiolitis obliterans syndrome after donor stem cell transplant; although azithromycin is not approved for prevention of this condition, the antibiotic is sometimes prescribed for that purpose.
A French study of 480 patients was undertaken to assess the effectiveness of this prophylaxis but revealed the increased risk of relapse and death and was halted 13 months after completing enrollment. The rate of cancer relapse was 32.9% in the azithromycin group and just 20.8% in the placebo group; the 2-year survival rate was 56.6% in the azithromycin group and 70.1% in the placebo group (JAMA 2017;318[6]:557-66).
Bronchiolitis obliterans syndrome is marked by inflammation and scarring of the airways that leads to severe shortness of breath and dry cough. There are no known effective antibiotic treatments for prophylaxis of the condition, according to the FDA.
FDA officials are advising physicians not to prescribe long-term azithromycin in this population. Patients who have had a stem cell transplant and are already taking the antibiotic, should consult a doctor before discontinuing.
The manufacturer of brand name azithromycin (Zithromax) has issued a Dear Healthcare Provider letter about the safety issue, and more information can be found in the FDA’s safety announcement.
FDA approves second drug for thrombocytopenia in liver disease
The Food and Drug Administration has approved lusutrombopag (Mulpleta) for the treatment of thrombocytopenia in patients with chronic liver disease who are scheduled to undergo medical or dental procedures. The drug is expected to be available in the United States in September 2018.
In May 2018, the FDA approved avatrombopag (Doptelet) as the first treatment for thrombocytopenia in this patient population.
The approval is based on a pair of phase 3, double-blind, placebo-controlled clinical trials – L-PLUS 1 and L-PLUS 2 (NCT02389621) – that included 312 patients who have chronic liver disease with severe thrombocytopenia. In L-PLUS 1, the primary endpoint was the percentage of patients who didn’t need platelet transfusions before the primary procedure was performed; this was met by 78% in the lusutrombopag group versus just 13% in the control group. In L-PLUS 2, the primary endpoint was the percentage of patients who didn’t need platelet transfusions before the procedure and didn’t require rescue therapy from randomization through 7 days post procedure; this was met by 65% of patients the lusutrombopag group versus 29% of patients the control group.
The most common adverse event was headache, and the recommended dosage for lusutrombopag is 3 mg orally once daily with or without food for 7 days. Lusutrombopag is not indicated for general platelet normalization in patients with chronic liver disease and thrombocytopenia. Full prescribing information and further information about the approval can be found on the FDA website.
Lusutrombopag was approved in Japan in 2015 for this indication and is slated to be evaluated by the European Medicines Agency in 2019. The drug is marketed by Shionogi.
The Food and Drug Administration has approved lusutrombopag (Mulpleta) for the treatment of thrombocytopenia in patients with chronic liver disease who are scheduled to undergo medical or dental procedures. The drug is expected to be available in the United States in September 2018.
In May 2018, the FDA approved avatrombopag (Doptelet) as the first treatment for thrombocytopenia in this patient population.
The approval is based on a pair of phase 3, double-blind, placebo-controlled clinical trials – L-PLUS 1 and L-PLUS 2 (NCT02389621) – that included 312 patients who have chronic liver disease with severe thrombocytopenia. In L-PLUS 1, the primary endpoint was the percentage of patients who didn’t need platelet transfusions before the primary procedure was performed; this was met by 78% in the lusutrombopag group versus just 13% in the control group. In L-PLUS 2, the primary endpoint was the percentage of patients who didn’t need platelet transfusions before the procedure and didn’t require rescue therapy from randomization through 7 days post procedure; this was met by 65% of patients the lusutrombopag group versus 29% of patients the control group.
The most common adverse event was headache, and the recommended dosage for lusutrombopag is 3 mg orally once daily with or without food for 7 days. Lusutrombopag is not indicated for general platelet normalization in patients with chronic liver disease and thrombocytopenia. Full prescribing information and further information about the approval can be found on the FDA website.
Lusutrombopag was approved in Japan in 2015 for this indication and is slated to be evaluated by the European Medicines Agency in 2019. The drug is marketed by Shionogi.
The Food and Drug Administration has approved lusutrombopag (Mulpleta) for the treatment of thrombocytopenia in patients with chronic liver disease who are scheduled to undergo medical or dental procedures. The drug is expected to be available in the United States in September 2018.
In May 2018, the FDA approved avatrombopag (Doptelet) as the first treatment for thrombocytopenia in this patient population.
The approval is based on a pair of phase 3, double-blind, placebo-controlled clinical trials – L-PLUS 1 and L-PLUS 2 (NCT02389621) – that included 312 patients who have chronic liver disease with severe thrombocytopenia. In L-PLUS 1, the primary endpoint was the percentage of patients who didn’t need platelet transfusions before the primary procedure was performed; this was met by 78% in the lusutrombopag group versus just 13% in the control group. In L-PLUS 2, the primary endpoint was the percentage of patients who didn’t need platelet transfusions before the procedure and didn’t require rescue therapy from randomization through 7 days post procedure; this was met by 65% of patients the lusutrombopag group versus 29% of patients the control group.
The most common adverse event was headache, and the recommended dosage for lusutrombopag is 3 mg orally once daily with or without food for 7 days. Lusutrombopag is not indicated for general platelet normalization in patients with chronic liver disease and thrombocytopenia. Full prescribing information and further information about the approval can be found on the FDA website.
Lusutrombopag was approved in Japan in 2015 for this indication and is slated to be evaluated by the European Medicines Agency in 2019. The drug is marketed by Shionogi.
FDA approves Perseris for schizophrenia
The Food and Drug Administration has approved Perseris, a once-monthly, long-acting injectable formulation of risperidone, for the treatment of schizophrenia in adults, according to a press release from the drug’s developer, Indivior.
The depot formulation of the atypical antipsychotic, administered subcutaneously, provides sustained levels of risperidone for 1 month; the process of injecting it also releases some of the drug, which helps achieve peak plasma levels within the first 4-6 hours. There is no need for either loading doses or supplemental oral doses with Perseris.
Efficacy was based on a phase 3, randomized, double-blind, placebo-controlled, 8-week study of 354 patients. The primary endpoint was improvement in Positive and Negative Syndrome Scale by day 57. Safety was evaluated in 814 patients who had participated in clinical trials of Perseris and was in line with the known safety profile of risperidone.
The most common adverse reactions, occurring in more than 5% of patients, were increased weight, sedation/somnolence, and musculoskeletal pain. Other risks included neuroleptic malignant syndrome, tardive dyskinesia, and hyperprolactinemia. Full prescribing information can be found on the manufacturer’s website.
The Food and Drug Administration has approved Perseris, a once-monthly, long-acting injectable formulation of risperidone, for the treatment of schizophrenia in adults, according to a press release from the drug’s developer, Indivior.
The depot formulation of the atypical antipsychotic, administered subcutaneously, provides sustained levels of risperidone for 1 month; the process of injecting it also releases some of the drug, which helps achieve peak plasma levels within the first 4-6 hours. There is no need for either loading doses or supplemental oral doses with Perseris.
Efficacy was based on a phase 3, randomized, double-blind, placebo-controlled, 8-week study of 354 patients. The primary endpoint was improvement in Positive and Negative Syndrome Scale by day 57. Safety was evaluated in 814 patients who had participated in clinical trials of Perseris and was in line with the known safety profile of risperidone.
The most common adverse reactions, occurring in more than 5% of patients, were increased weight, sedation/somnolence, and musculoskeletal pain. Other risks included neuroleptic malignant syndrome, tardive dyskinesia, and hyperprolactinemia. Full prescribing information can be found on the manufacturer’s website.
The Food and Drug Administration has approved Perseris, a once-monthly, long-acting injectable formulation of risperidone, for the treatment of schizophrenia in adults, according to a press release from the drug’s developer, Indivior.
The depot formulation of the atypical antipsychotic, administered subcutaneously, provides sustained levels of risperidone for 1 month; the process of injecting it also releases some of the drug, which helps achieve peak plasma levels within the first 4-6 hours. There is no need for either loading doses or supplemental oral doses with Perseris.
Efficacy was based on a phase 3, randomized, double-blind, placebo-controlled, 8-week study of 354 patients. The primary endpoint was improvement in Positive and Negative Syndrome Scale by day 57. Safety was evaluated in 814 patients who had participated in clinical trials of Perseris and was in line with the known safety profile of risperidone.
The most common adverse reactions, occurring in more than 5% of patients, were increased weight, sedation/somnolence, and musculoskeletal pain. Other risks included neuroleptic malignant syndrome, tardive dyskinesia, and hyperprolactinemia. Full prescribing information can be found on the manufacturer’s website.
FDA approves radioactive agent for adrenal tumors
(pheochromocytoma or paraganglioma) that are unresectable, have metastasized, and require systemic therapy.
This is the first FDA-approved drug for this use, the FDA said in a press announcement.
Approval is based on a single-arm, open-label clinical trial that included 68 patients. The primary endpoint was the number or patients with a 50% or greater reduction of antihypertensive medications lasting at least 6 months; the secondary endpoint was overall tumor response according to traditional imaging criteria. The primary endpoint was met by 17 patients, and the secondary endpoint was achieved in 15.
The most common severe side effects were lymphopenia, neutropenia, thrombocytopenia, fatigue, anemia, increased international normalized ratio, nausea, dizziness, hypertension, and vomiting. Furthermore, because this is a radioactive therapeutic agent, there is a warning about radiation exposure for both patients and family members, a risk that is greatest in pediatric patients.
Other warnings and precautions include a risk of myelosuppression, underactive thyroid, elevations in blood pressure, renal failure or kidney injury, and pneumonitis. Myelodysplastic syndrome and acute leukemias were observed in patients who received the radioactive agent, and the magnitude of this risk will continue to be studied, the FDA said.
The approval was granted to Progenics Pharmaceuticals.
(pheochromocytoma or paraganglioma) that are unresectable, have metastasized, and require systemic therapy.
This is the first FDA-approved drug for this use, the FDA said in a press announcement.
Approval is based on a single-arm, open-label clinical trial that included 68 patients. The primary endpoint was the number or patients with a 50% or greater reduction of antihypertensive medications lasting at least 6 months; the secondary endpoint was overall tumor response according to traditional imaging criteria. The primary endpoint was met by 17 patients, and the secondary endpoint was achieved in 15.
The most common severe side effects were lymphopenia, neutropenia, thrombocytopenia, fatigue, anemia, increased international normalized ratio, nausea, dizziness, hypertension, and vomiting. Furthermore, because this is a radioactive therapeutic agent, there is a warning about radiation exposure for both patients and family members, a risk that is greatest in pediatric patients.
Other warnings and precautions include a risk of myelosuppression, underactive thyroid, elevations in blood pressure, renal failure or kidney injury, and pneumonitis. Myelodysplastic syndrome and acute leukemias were observed in patients who received the radioactive agent, and the magnitude of this risk will continue to be studied, the FDA said.
The approval was granted to Progenics Pharmaceuticals.
(pheochromocytoma or paraganglioma) that are unresectable, have metastasized, and require systemic therapy.
This is the first FDA-approved drug for this use, the FDA said in a press announcement.
Approval is based on a single-arm, open-label clinical trial that included 68 patients. The primary endpoint was the number or patients with a 50% or greater reduction of antihypertensive medications lasting at least 6 months; the secondary endpoint was overall tumor response according to traditional imaging criteria. The primary endpoint was met by 17 patients, and the secondary endpoint was achieved in 15.
The most common severe side effects were lymphopenia, neutropenia, thrombocytopenia, fatigue, anemia, increased international normalized ratio, nausea, dizziness, hypertension, and vomiting. Furthermore, because this is a radioactive therapeutic agent, there is a warning about radiation exposure for both patients and family members, a risk that is greatest in pediatric patients.
Other warnings and precautions include a risk of myelosuppression, underactive thyroid, elevations in blood pressure, renal failure or kidney injury, and pneumonitis. Myelodysplastic syndrome and acute leukemias were observed in patients who received the radioactive agent, and the magnitude of this risk will continue to be studied, the FDA said.
The approval was granted to Progenics Pharmaceuticals.
FDA: Cancer risk low with recalled valsartan
The risk of cancer from N-nitrosodimethylamine (NDMA) contained in impure valsartan is real but very low, the Food and Drug Administration said in a July 27 statement.
The agency had announced a voluntary recall of valsartan from Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals, as well as valsartan/hydrochlorothiazide from Solco and Teva, on July 13 after detection of NDMA, a semi-volatile organic compound. The manufacturer, Zhejiang Huahai Pharmaceuticals in Linhai, China, has since stopped distribution. Contamination probably is tied to a change in the manufacturing process.
NDMA has been linked to cancer in animal studies but at levels “much higher than the impurity levels in recalled valsartan batches.” Even so, the agency “wanted to put some context around the actual potential risk posed to patients who used versions of valsartan that may have contained high levels of NDMA,” the FDA said in its updated press release.
Based on records from the manufacturer, “some levels of the impurity may have been in the valsartan-containing products for as long as 4 years. FDA scientists estimate that if 8,000 people took the highest valsartan dose (320 mg) from the recalled batches daily for the full 4 years, there may be one additional case of cancer over the lifetimes of these 8,000 people,” the agency said.
“To put this in context, currently one out of every three people in the U.S. will experience cancer in their lifetime,” it said.
The FDA advised patients to check their prescriptions to see if they originate from one of the recalled batches, and to let their doctors and pharmacists know if they are.
To help, the FDA has posted a list of products included in the recall and a list of products not included in the recall.
They should also follow the recall instructions provided by the specific companies, the FDA said.
The risk of cancer from N-nitrosodimethylamine (NDMA) contained in impure valsartan is real but very low, the Food and Drug Administration said in a July 27 statement.
The agency had announced a voluntary recall of valsartan from Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals, as well as valsartan/hydrochlorothiazide from Solco and Teva, on July 13 after detection of NDMA, a semi-volatile organic compound. The manufacturer, Zhejiang Huahai Pharmaceuticals in Linhai, China, has since stopped distribution. Contamination probably is tied to a change in the manufacturing process.
NDMA has been linked to cancer in animal studies but at levels “much higher than the impurity levels in recalled valsartan batches.” Even so, the agency “wanted to put some context around the actual potential risk posed to patients who used versions of valsartan that may have contained high levels of NDMA,” the FDA said in its updated press release.
Based on records from the manufacturer, “some levels of the impurity may have been in the valsartan-containing products for as long as 4 years. FDA scientists estimate that if 8,000 people took the highest valsartan dose (320 mg) from the recalled batches daily for the full 4 years, there may be one additional case of cancer over the lifetimes of these 8,000 people,” the agency said.
“To put this in context, currently one out of every three people in the U.S. will experience cancer in their lifetime,” it said.
The FDA advised patients to check their prescriptions to see if they originate from one of the recalled batches, and to let their doctors and pharmacists know if they are.
To help, the FDA has posted a list of products included in the recall and a list of products not included in the recall.
They should also follow the recall instructions provided by the specific companies, the FDA said.
The risk of cancer from N-nitrosodimethylamine (NDMA) contained in impure valsartan is real but very low, the Food and Drug Administration said in a July 27 statement.
The agency had announced a voluntary recall of valsartan from Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals, as well as valsartan/hydrochlorothiazide from Solco and Teva, on July 13 after detection of NDMA, a semi-volatile organic compound. The manufacturer, Zhejiang Huahai Pharmaceuticals in Linhai, China, has since stopped distribution. Contamination probably is tied to a change in the manufacturing process.
NDMA has been linked to cancer in animal studies but at levels “much higher than the impurity levels in recalled valsartan batches.” Even so, the agency “wanted to put some context around the actual potential risk posed to patients who used versions of valsartan that may have contained high levels of NDMA,” the FDA said in its updated press release.
Based on records from the manufacturer, “some levels of the impurity may have been in the valsartan-containing products for as long as 4 years. FDA scientists estimate that if 8,000 people took the highest valsartan dose (320 mg) from the recalled batches daily for the full 4 years, there may be one additional case of cancer over the lifetimes of these 8,000 people,” the agency said.
“To put this in context, currently one out of every three people in the U.S. will experience cancer in their lifetime,” it said.
The FDA advised patients to check their prescriptions to see if they originate from one of the recalled batches, and to let their doctors and pharmacists know if they are.
To help, the FDA has posted a list of products included in the recall and a list of products not included in the recall.
They should also follow the recall instructions provided by the specific companies, the FDA said.