By Robert Lowes
WebMD Health News
April 03, 2017
Ten drugs or drug classes treating everything from obesity to arthritis made the latest watch list of drugs with possible safety issues that was released by the US Food and Drug Administration (FDA) last week.
The list reflects potential signals of serious risk or new safety information collected by the FDA Adverse Event Reporting System (FAERS) in the fourth quarter of 2016.
The combination of naltrexone and bupropion (Contrave, Orexigen Therapeutics) for weight loss was flagged because the FDA received reports that some patients were losing consciousness. Likewise, the agency detected a possible signal of diarrhea, vomiting, and nausea for the arthritis drug apremilast (Otezla, Celgene).
The FDA cautions that a drug's appearance on a quarterly FAERS watch list does not mean the agency has established a causal relationship with the cited adverse event. Instead, the agency is studying the need for regulatory action. If the FDA concludes that there is a causal link, it can collect more information to better describe the threat, revise the drug's label, order a risk evaluation and mitigation strategy, or withdraw the drug from the market.
Sometimes the FDA already has put the matter of a drug's potential risk signal to rest before it publishes the watch list. This kind of regulatory resolution was true for the diabetes drug glyburide (Diabeta, Sanofi-Aventis) in the fourth quarter list for 2016. The agency has updated the adverse-events section of the drug's label to include bullous reactions, erythema multiforme, and exfoliative dermatitis. Another example is ibrutinib (Imbruvica, Pharmacyclics and Janssen), indicated for chronic lymphocytic leukemia/small lymphocytic lymphoma, and two other types of lymphoma. The label was updated to warn about the risk for Pneumocystis jirovecii pneumonia.
For the full list, click here.