Drugs

Public Citizen Wants Prandin, Plavix Label Changes

Public Citizen says that FDA should require changes to the labels for repaglinide-containing medications (Novo Nordisk’s Prandin and Prandimet) and clopidogrel (Bristol-Myers Squibb’s Plavix) to include information on what it says is a serious drug-drug interaction that could result in severe hypoglycemia. The advocacy group’s petition also says that the labels for both drugs should include a Contraindication to using the two drugs together due to the interaction.

Studies conducted in Finland and Japan established the dangerous interaction, Public Citizen says. It notes that on 7/31/15, Health Canada issued an alert to healthcare professionals warning about the risk of dangerously low blood sugar levels when the two drugs are taken together. It also required that Canadian product labels for each drug be updated to reflect information about the interactions and to include a contraindication warning against taking the two drugs together under any circumstances.

“FDA has not taken similar actions,” the petition says. “Regarding the U.S. product labels, only the label for clopidogrel includes information on the interaction with repaglinide, within the Drug Interactions section. Inexplicably, FDA has not required the same information to be inserted into the label for repaglinide. Moreover, there is no Contraindication to the use of the two drugs together in either label, as was put in place in Canada.”

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