Drugs

Celebrex as Safe as Aleve and Motrin: Advisors

Members of the FDA Arthritis Advisory Committee and Drug Safety and Risk Management Committee voted 15-5-1 that the post-marketing PRECISION study demonstrates that Pfizer’s Celebrex (celecoxib) has comparable cardiovascular safety with naproxen (Aleve) and ibuprofen (Motrin). If FDA accepts the recommendation, the study results will be added to the Celebrex labeling.

News accounts indicate that for more than a decade some doctors have been reluctant to prescribe Celebrex because it is similar to Vioxx, which was withdrawn from the market in 2004 due to safety concerns. Both drugs are Cox-2 inhibitors that act by blocking an enzyme involved in inflammation.

The PRECISION study involved more than 24,000 patients with osteoarthritis and rheumatoid arthritis. Participants took either Celebrex, prescription ibuprofen, or prescription naproxen. The study found no evidence that Celebrex posed any greater risk for heart attacks or strokes than the two NSAIDs.

Reports indicate that many committee members stressed that Celebrex isn’t completely safe. The study showed that it can increase the chance of cardiovascular complications. But it doesn’t appear to increase the odds of such complications as much as Vioxx did, or apparently even as much as prescription doses of ibuprofen or naproxen.

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