Drugs

Statin Pregnancy Contraindication Lifted

FDA has announced a class-wide labeling change for cholesterol-lowering statin drugs to remove its strongest warning against their use in pregnant patients. “We have conducted a comprehensive review of all available data and are requesting that statin manufacturers make this change to the prescribing information as part of FDA’s ongoing effort to update the pregnancy and breastfeeding information for all prescription medicines,” an agency notice says.

Despite the change, FDA is still recommending that most patients should stop statins once they learn they are pregnant. “Patients should not breastfeed when taking a statin because the medicine may pass into breast milk and pose a risk to the baby,” it says.

FDA says it is requesting statin drug makers to revise their prescribing information to remove the current contraindication against using these medicines in all pregnant patients. “Because the benefits of statins may include prevention of serious or potentially fatal events in a small group of very high-risk pregnant patients, contraindicating these drugs in all pregnant women is not appropriate,” it says.

The move comes one day after FDA officials announced a “major paradigm shift” to move the clinical development community from “systemic exclusion to the inclusion” of pregnant and breastfeeding women in clinical studies (see earlier story). Writing in an online FDA Voices post, officials say it is time to give this patient population needed data about the safety or effectiveness of drugs used during pregnancy.

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