Drugs

Makary Pledges Mifepristone Study

FDA commissioner Martin Makary says the agency will conduct a review of the abortion drug mifepristone. Makary included the pledge in a 6/2 letter to Sen. Josh Hawley (R-MO), according to an online National Review story.

Makary declined to comment further to the newsletter due to ongoing litigation over the drug that is now used for many abortions in the U.S.

The story says Hawley had called to Makary’s attention a study from the conservative Ethics and Public Policy Center (EPPC) that found mifepristone is much less safe than previously thought. The study found that almost 11% of women experience a serious adverse effect within 45 days following a mifepristone abortion, National Review says. That figure is 22 times higher than the labeling reports, it adds. EPPC says serious adverse events include sepsis, infection, and hemorrhaging.

“I’m calling on FDA to reinstate safety regulations on the chemical abortion drug immediately,” Hawley said. “New data out today show a massive number of severe medical side effects.”

The report says the EPPC study was based on an analysis of an insurance claims database with 865,727 prescribed mifepristone abortions from 2017-2023, “a sample that dwarfs the size of all FDA-cited clinical trials on the abortion drug put together.”

Before the release of the EPPC study, Makary had said he did not plan to do anything to restrict mifepristone but left open the possibility of future action if new data warranted it. At his confirmation hearing, National Review says, Makary told senators he would oversee a mifepristone review without committing to anything specific.

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