Drugs

Avoid NSAIDs in Pregnancy After 20 Weeks: FDA

An FDA drug safety communication warns that the use of nonsteroidal anti-inflammatory drugs (NSAIDs) around 20 weeks or later in pregnancy may cause rare but serious kidney problems in an unborn baby. The notice says the use of NSAIDs can lead to low levels of amniotic fluid surrounding the baby and possible complications.

“After around 20 weeks of pregnancy, the unborn baby’s kidneys produce most of the amniotic fluid, so kidney problems can lead to low levels of this fluid,” the notice says. “Although this safety concern is well known among certain medical specialties, we want to communicate our recommendations more widely to educate other healthcare professionals and pregnant women,” FDA says. “The issue affects all NSAIDs that are available by prescription and those that can be bought over-the-counter (OTC) without a prescription.”

The agency says that for prescription NSAIDs it is requiring labeling changes to describe the risk of kidney problems in unborn babies that result in low amniotic fluid. FDA says it also will update the Drug Facts labels of OTC NSAIDs intended for use in adults.

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