July 20, 2021
1 min read

FDA requests removal of strongest warning against statin use among pregnant women

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The FDA requested removal of its contraindication against using cholesterol-lowering statin medicines among pregnant patients; however, most patients should stop statins once they learn they are pregnant.

A contraindication is the FDA’s strongest warning and only added when a medicine should not be used due to risk that outweighs any possible benefit.

FDA HQ in Washington
Source: Adobe Stock

According to an FDA press release, statins may prevent major adverse events among certain high-risk patients who are pregnant; therefore, contraindicating statin therapy for all pregnant women is not appropriate.

The FDA added that patients who are breastfeeding should halt statin therapy, as the drug may pass into breast milk and pose a risk to the baby, and many can resume treatment when breastfeeding ends.

According to the release, patients requiring ongoing statin therapy should not breastfeed and instead use infant formula or other alternatives.

“FDA expects removing the contraindication will enable health care professionals and patients to make individual decisions about benefit and risk, especially for those at very high risk of heart attack or stroke,” the FDA wrote in a drug safety communication. “This includes patients with homozygous familial hypercholesterolemia and those who have previously had a heart attack or stroke. Statins are safe to use in patients who are not pregnant but may become pregnant.”