Drugs

Advisors Want Chantix Boxed Warning Pulled

Members of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 10-9 on 9/14 to recommend that FDA remove a Boxed Warning from labeling for Pfizer’s smoking-cessation drug Chantix (varenicline). The Boxed Warning contains statements about the risk of serious neuropsychiatric events associated with the drug. Five members of the two committees said that the agency should keep the Boxed Warning statements and four said it should modify the language.

The votes followed discussion of a completed post-marketing trial requirement that looked at the neuropsychiatric effects of Chantix, Zyban (bupropion), and nicotine replacement therapy. The committees also reviewed relevant data from published observational studies. FDA held the joint meeting to help it decide if the study findings support changes to product labeling.

Committee members discussed the strengths and weaknesses of the EAGLES trial in which the observed rate of neuropsychiatric events among patients without a prior history for neuropsychiatric events was lower among subjects randomized to Chantix.

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