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FDA Panel Seeks Tougher Antibiotic Labels

SILVER SPRING, Md.—A Food and Drug Administration advisory panel overwhelmingly called for heightened label warnings on widely prescribed antibiotics called fluoroquinolones because of unusual but sometimes devastating side effects.

The action followed a day of emotional testimony from dozens of patients who said these drugs have had a wide range of harmful effects on their health and cognitive ability.

The agency decided earlier this year to have its advisory committee examine the class of antibiotics because of mounting evidence of previously unknown, and sometimes permanent, side effects.

Panel member Dr. Tobias Gerhard, professor in the Department of Pharmacy Practice at Rutgers University, said the panel voted for the stronger label warnings “because of the remarkable testimony that we have heard today.”

The drugs are commonly prescribed, with a total of more than 36 million prescriptions issued in 2014, according to drug-research firm IMS Health. IMS 0.04 % The panel was examining the drugs for their safety when used to treat sinus infections, urinary-tract infections and bronchitis that worsens existing chronic obstructive pulmonary disease.

The panel was asked to consider whether the current labels adequately explain the benefits and risks for the three conditions and, if not, whether the labels should be revised. The vote for revising labels was 21-0 on sinusitis; 18-2, with one abstention, on bronchitis; and 20-1 regarding urinary-tract infections.

The FDA doesn’t have to follow advisory panels’ recommendations, but it often does so. The panel didn’t...


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