NLA Statement on FDA Drug Safety Communication Regarding Statins and Pregnancy

The U.S. Food and Drug Administration released a Drug Safety Communication on July 20, 2021, concerning the removal of the strongest warning against using statins during pregnancy. The warning states that statins should never be used in any patients during pregnancy.

After reviewing recent literature, the FDA is now requesting that manufacturers of statins remove FDA’s strongest warning in the current prescribing information.   Observational studies of statin use in pregnant women have not identified a drug-associated risk of major birth defects when controlling for other risks such as diabetes. Data are insufficient to determine if there is a drug-associated risk of miscarriage.  Overall, animal data suggest limited potential of statins to cause birth defects or miscarriage and limited potential to affect nervous system development in an unborn baby. However, because statins decrease the body’s ability to make cholesterol and possibly other substances, the FDA notes that it is possible these medicines could harm an unborn baby when taken by a pregnant mother.

Removing the warning will enable clinicians and patients to make individual decisions about benefits and risks of statin use. Because some patients at very high risk for cardiovascular events (e.g., those with homozygous familial hypercholesterolemia or with prior cardiovascular events) may benefit from statins, individual clinicians may consider the possible benefits of continuing statins during pregnancy. The FDA communication did state that breastfeeding is not recommended in patients taking a statin.  There are data for some statins showing that they can pass into breast milk.   If a woman needs to or wants to take a statin after delivery, she should not breastfeed the baby.  The statin should be stopped until breastfeeding ends.

One particular comment that may be beneficial for patient care is that the FDA affirms that statins are safe in women who are not pregnant but could become pregnant. These women can be reassured that unintended exposure to statins during early pregnancy is unlikely to be harmful to the developing fetus.   Most clinicians may still choose to stop statins prior to a planned pregnancy.