Sumary of FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises most pregnant patients should stop taking statins:
- 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.
- 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.