Drugs

Pull Benicar from Market: Public Citizen

Public Citizen is petitioning FDA to withdraw from the market all medications containing the angiotensin II receptor blocker (ARB) olmesartan medoxomil (Daiichi Sankyo’s Azor, Benicar, Benicar HCT, and Tribenzor, with all generics of these drugs). The advocacy group petition says that olmesartan medoxomil is associated with a risk of sprue-like enteropathy and that multiple other ARBs that do not appear to have the same risk of sprue-like enteropathy have been approved by FDA for treating hypertension.

“In summary,” the petition says, “olmesartan medoxomil has unique serious risks but no unique benefit.”

According to the petition, olmesartan medoxomil is a pro-drug that is metabolized in the gastrointestinal tract and liver to its active form — olmesartan. The first olmesartan product was approved by FDA in 2002 for treating hypertension.

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