Drugs

FDA Denies Public Citizen Ketoconazole Petition

FDA has denied a 2/24/15 Public Citizen petition seeking the immediate removal of ketoconazole 200 mg oral tablets (Janssen’s Nizoral and generics) from the market because its risk of fatal liver failure and adrenal insufficiency and its numerous drug interactions outweigh its limited benefits in treating fungal infections. The agency’s denial letter says FDA disagrees with the petition’s conclusion that there are no patients for whom the benefits of ketoconazole outweigh its risks.

The agency notes that the petition relied heavily on a 2013 assessment of ketoconazole benefits and risks prepared by the CDER Office of Surveillance and Epidemiology. The letter says that assessment was not the ultimate conclusion of the agency with respect to ketoconazole. And it says that since 2013 FDA has continued to review all new sources of information on ketoconazole safety and has conducted a substantial literature search and analysis of pharmacoepidemiologic data on hepatoxicity and ketoconazole. “Based on available information, FDA concludes that ketoconazole should remain on the market for the limited indications for which it is approved,” the letter says.

Although the drug will remain on the market, FDA says, it is requiring safety labeling changes to provide adequate safety warnings to prescribers about the drug’s risks. “There are limited treatment options for patients who have endemic mycoses, the effects of which can be serious and life-threatening,” FDA concludes. “FDA’s updated analyses support the agency’s conclusion that the risks and benefits of ketoconazole remain favorable for treatment of patients with these systemic fungal infections who do not have other treatment options.”

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