Drugs

Celebrex Passes FDA-ordered Safety Study: Pfizer

An FDA-ordered safety study of Pfizer’s arthritis drug Celebrex (celecoxib) demonstrated similar rates of cardiovascular risk in patients treated with prescription doses of celecoxib, ibuprofen and naproxen who had a clinical diagnosis of osteoarthritis or rheumatoid arthritis, were at high risk for cardiovascular disease, and required daily treatment with non-steroidal anti-inflammatory drugs (NSAIDs) to control symptoms of arthritis. Published in the New England Journal of Medicine, the study showed that “patients treated with celecoxib experienced significantly fewer gastrointestinal events as compared with those receiving prescription doses of ibuprofen or naproxen,” Pfizer says. “The PRECISION trial helps to refute the assumption held by many physicians that naproxen treatment results in better cardiovascular outcomes as compared to other NSAIDs, including celecoxib. It is important to note that given the trial’s design – prescription doses and chronic use in patients with cardiovascular risk factors – no inferences are possible regarding the safety of intermittent use of low-dose, over-the-counter NSAIDs.”

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