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  5. Drug Safety Oversight Board Meeting - May 17, 2018
  1. Center for Drug Evaluation and Research | CDER

Drug Safety Oversight Board Meeting - May 17, 2018

Public Summary

The following 5 Drug Safety Communications have posted since the January 18, 2018 DSB meeting.

  • April 25, 2018: FDA warns of serious immune system reaction with seizure and mental health medicine lamotrigine (Lamictal)
    • The FDA is warning that the medicine lamotrigine (Lamictal) for seizures and bipolar disorder can cause a rare but very serious reaction that excessively activates the body’s infection-fighting immune system. This can cause severe inflammation throughout the body and lead to hospitalization and death, especially if the reaction is not diagnosed and treated quickly.
    • FDA is requiring a new warning about this risk be added to the prescribing information in the lamotrigine drug labels.
  • February 22, 2018: FDA review finds additional data supports the potential for increased long-term risks with antibiotic clarithromycin (Biaxin) in patients with heart disease
    • The FDA is advising caution before prescribing the antibiotic clarithromycin (Biaxin) to patients with heart disease because of a potential increased risk of heart problems or death that can occur years later.
    • This recommendation is based on FDA’s review of the results of a 10-year follow-up study of patients with coronary heart disease from a large clinical trial that first observed this safety issue.
    • FDA has added a new warning about this increased risk of death in patients with heart disease, and advised prescribers to consider using other antibiotics in such patients.
    • FDA has also added the study results to the clarithromycin drug labels.
  • February 1, 2018 (update to September 21, 2017 DSC): FDA adds Boxed Warning to highlight correct dosing of Ocaliva (obeticholic acid) for patients with a rare chronic liver disease
    • The FDA is warning that the liver disease medicine Ocaliva (obeticholic acid) has been incorrectly dosed daily instead of weekly in patients with moderate to severe primary biliary cholangitis (PBC), a rare chronic liver disease, increasing the risk of serious liver injury.
    • To ensure correct dosing and reduce the risk of liver problems, FDA is clarifying the current recommendations for screening, dosing, monitoring, and managing PBC patients with moderate to severe liver disease taking Ocaliva.
    • FDA is adding a new Boxed Warning, FDA’s most prominent warning, to highlight this information in the prescribing information of the drug label. FDA is also requiring a Medication Guide for patients to inform them about this issue.
  • January 30, 2018 (update to June 7, 2016 DSC): FDA limits packaging for anti-diarrhea medicine Loperamide (Imodium) to encourage safe use
    • To foster safe use of the over-the counter (OTC) anti-diarrhea drug loperamide, the U.S. Food and Drug Administration (FDA) is working with manufacturers to use blister packs or other single dose packaging and to limit the number of doses in a package.

    • FDA continues to receive reports of serious heart problems and deaths with much higher than the recommended doses of loperamide, primarily among people who are intentionally misusing or abusing the product, despite the addition of a warning to the medicine label and a previous communication. Loperamide is a safe drug when used as directed.

  • January 11, 2018 (update to April 20, 2017 DSC): FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older:

    • FDA is also requiring the addition of safety information about the risks of misuse, abuse, addiction, overdose, death, and slowed or difficult breathing to the Boxed Warning, our most prominent warning, of the drug labels for prescription cough and cold medicines containing codeine or hydrocodone.

    • FDA is taking this action after conducting an extensive review and convening a panel of outside experts. Both of these determined the risks of slowed or difficult breathing, misuse, abuse, addiction, overdose, and death with these medicines outweigh their benefits in patients younger than 18.

The Board heard three presentations:

Unapproved Drugs and Patient Care (Donald Ashley, J.D., Director, Office of Compliance/CDER; James Flahive, J.D., Branch Chief, Office of Unapproved Drugs and Labeling Compliance, Prescription Drugs Branch, CDER-OC)

Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) (Doris Auth, Pharm.D. Associate Director, Division of Risk Management, Office of Medication Error Prevention and Risk Management, Division of Medication Error Prevention and Analysis, OSE)

Evidence-based Targets for Initial Opioid Analgesic Prescribing Limits for Acute Pain: Preliminary Results and Future Directions (Tamra Meyer, Ph.D., MPH, Lead Epidemiologist, Division of Epidemiology II, Office of Pharmacology and Epidemiology (OPE), OSE; Mallika Mundkur, M.D., MPH, Medical Officer, Division of Pharmacology II, OPE, OSE)

Views expressed by non-CDER employees are those of the individual and not necessarily the opinion of his/her respective federal agency or institution.


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