Drugs

State Lack of Fenofibrate CV Benefit: Petition

Healthy Women, an educational resource for women ages 35-64, is calling on FDA to revise the labeling for all fenofibrate drugs to “remedy the widespread misimpression among healthcare professionals that fenofibrates, when used alone or in combination with statins, reduce cardiovascular risk, and the resulting pervasive, improper use of fenofibrates.” The group’s petition also asks that the drugs’ labeling be changed to incorporate new information from the recently published PROMINENT study and take further action to ensure that the information is communicated to healthcare providers and patients.

“Significantly,” the petition says, “the data from the recent PROMINENT study settled a scientific issue that has been pending for years — whether fibrates have cardiovascular benefits…. All of the studies examining this question have answered it with a resounding ‘no.’”

Healthy Women says it acknowledges and applauds the substantial actions FDA has already taken to debunk the presumed association between fenofibrates and cardiovascular benefit. But, it says, surveys of cardiologists, primary care doctors, and pharmacists indicate there remains marked confusion over whether fenofibrates reduce cardiovascular risk.

“Neither women nor men are being adequately treated for residual cardiovascular risk, offered the full spectrum of available and appropriate interventions, and they are being exposed to unnecessary fenofibrate-related risks,” the petition says. It calls for the labeling changes since, it says, FDA-approved labeling is the primary tool for communicating drug information to healthcare professionals.

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