Drugs

Clopidogrel Boxed Warning Petition Denied

FDA has denied an 8/21/13 Public Citizen petition asking that it require a Boxed Warning on labeling for clopidogrel tablets (Bristol-Myers Squibb’s Plavix) addressing the “increased risk of major and minor bleeding with use beyond 12 months following implantation of a drug-eluting coronary artery stents.” The agency’s denial letter notes that findings from the Dual Antiplatelet Therapy (DAPT) trial demonstrated that use of the drug for up to 30 months in patients who received a drug-eluting stent reduced the rate of ischemic events, even though the benefit of extended therapy was accompanied by an increase in bleeding events.

“We agree with the 2016 ACC/AHA DAPT guidelines’ recommendation that decisions regarding the duration of DAPT in patients who have received a drug-eluting stent should be made on a case-by-case basis by clinicians familiar with the individual characteristics of the patient to best address the needs of each patient,” the letter says. “An unqualified statement advising physicians that continuation of clopidogrel for longer than 12 months following percutaneous insertion of a drug-eluting stent is of questionable additional benefit in a Boxed Warning, or indeed in any section of labeling, and would be inconsistent with available data.”

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