Drugs

Update Drug Labels with Obesity Info: Pitts

Former FDA associate commissioner Peter Pitts says the agency doesn’t routinely update drug labels with safety information for people with obesity. “The agency…doesn’t know (and it seems doesn’t care) if people with obesity are dosed safely or effectively with approved products since large-scale clinical trials regularly and purposely exclude them, per clinical trial designs approved by FDA,” he writes in a Center for Medicine in the Public Interest blog post. “Such scientific omission is irrational, unscientific, not in the best interests of patients, contrary to the wishes of medical professionals, and just plain wrong.”

Pitts says FDA commissioner Martin Makary should ask why his agency requires labels to include hepatic impairment pharmacokinetic information but not information for patients with obesity, since the population of people with hepatic impairments is a twentieth the size of people with obesity. He says FDA needs to say why neither drug developers nor the agency have acted on this recognized and solvable public health blind spot.

“Obesity is not a rare or orphan disease,” Pitts says. “But that shouldn’t mean the agency can ignore a condition that impacts nearly 100 million adult Americans. It is both shocking and disappointing that FDA hasn’t acted with more urgency to proactively remediate drug labels so that physicians can be aware of both the problem and the solution…. Now is the time to rectify this serious oversight, prove to HHS secretary Robert F. Kennedy, Jr., that the agency isn’t an industry ‘sock puppet,’ and help advance the health of a population that represents 40% of the U.S. population. To continue to ignore this problem is regulatory malpractice of the first order.”

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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