Drugs

A Third of Drug Approvals have Post-market Safety Issues: JAMA

A new study published in JAMA finds that nearly a third of recently approved drugs resulted in adverse events that led to new boxed warnings or safety alerts. Researchers examined more than 222 new drug and biologics approvals from 2001 through 2010. They documented 123 significant postmarket safety events (3 withdrawals, 61 boxed warnings, and 59 safety communications) during a median follow-up period of 11.7 years, affecting 32% of the novel therapeutics. “The median time from approval to first postmarket safety event was 4.2 years, and the proportion of novel therapeutics affected by a postmarket safety event at 10 years was 31%, Yale University School of Medicine researcher Joseph S. Ross and colleagues write.

Postmarket safety events were significantly more frequent among biologics, those receiving accelerated approval, and those with near-regulatory deadline approval, the researchers say. “Events were significantly less frequent among those with regulatory review times less than 200 days.”

The authors also note that the majority of pivotal trials that form the basis for FDA approval for the products enroll fewer than 1,000 patients with follow-up of six months or less — making it a challenge to identify uncommon or long-term serious safety risks. They add that limited exposure in the premarket stage highlights “the need for continuous monitoring of the safety of novel therapeutics throughout their life cycle.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome