Drugs

FDA Grants, Denies Prandin/Plavix Petition

FDA has granted in part and denied in part a 12/28/16 Public Citizen petition seeking label changes for medications containing repaglinide (Prandin, PrandimMet) and clopidogrel (Plavix). The petition specifically asked the agency to require that:

the label of repaglinide-containing medications include information on a serious drug-drug interaction with Plavix that could result in severe hypoglycemia; and
the labels of both repaglinide-containing medications and clopidogrel include a Contraindication to using the two drugs together due to the interaction.

The FDA response letter says the agency approved 2/8/17 two labeling supplements for Prandin, adding information about the risk of hypoglycemia and drug-drug interaction information about concomitant use of repaglinide and clopidogrel. It says the agency would support similar changes for the PrandiMet label. And, the letter says, FDA has approved revisions adding information to the Drug Interactions section of the Plavix labeling.

“Accordingly,” it says, “your request that the labeling for products with repaglinide include information on a drug-drug interaction with clopidogrel is granted. However, the petition is denied to the extent that it requests a Contraindication to the use of repaglinide and clopidogrel together…. Although we agree that the additional language … for the repaglinide and clopidogrel labeling is appropriate, we disagree that a Contraindication is required. FDA believes that the risks associated with a drug-drug interaction occur when repaglinide is taken with the 300 mg dose of clopidogrel. The 300 mg dose is indicated only for acute coronary syndrome, Affected patients typically are under intense monitoring in a hospital and would receive a 300 mg dose under these conditions. FDA is not aware of any significant postmarketing safety signals that the drug-drug interaction has caused serious hypoglycemia.”

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

Read more

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