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Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information.

On July 20, 2021, FDA requested removal of its strongest warning against using cholesterol-lowering statin medicines in pregnant patients. Despite the change, most patients should stop statins once they learn they are pregnant. 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.

Patients should not breastfeed when taking a statin because it may pass into breast milk and pose a risk to the baby. Many can stop statins temporarily until breastfeeding ends. However, patients requiring ongoing statin treatment should not breastfeed and instead use infant formula or other alternatives.

We are requesting revisions to the information about use in pregnancy in the prescribing information of the entire class of statin medicines. These changes include removing the 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.

FDA expects removing the contraindication will enable health care professionals and patients to make individual decisions about benefit and risk.

Health care professionals should discontinue statin therapy in most pregnant patients. Because of the chronic nature of cardiovascular disease, treatment of hyperlipidemia is not generally necessary during pregnancy. When FDA approved the first statin in 1987, the medicine came with our strongest warning recommending against use during pregnancy and breastfeeding.

Since then, multiple randomized trials and meta-analyses have demonstrated the benefit of statin therapy for the prevention of cardiovascular events. In addition, data from published observational studies of statin use in pregnant women have not identified a drug-associated risk of major birth defects when controlling for other risks and are insufficient to determine if there is a drug-associated risk of miscarriage.

Side effects involving statins and other medicines should be reported to FDA’s MedWatch program at www.fda.gov/medwatch.

A link to the full communication detailing specific information for health care professionals and the complete Data Summary can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at [email protected].

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