July 20, 2021

The U.S. FDA has requested that statin manufacturers remove a contraindication from their products’ prescribing information that cautions against statin use in all pregnant patients. According to the FDA, this will allow prescribers and patients “to make individual decisions about benefit and risk, especially for those at very high risk of heart attack or stroke.”

Statins reduce the amount of cholesterol produced by the liver and help the liver remove cholesterol from the body. They can also help prevent heart attack and stroke caused by plaque buildup in blood vessel walls. When the FDA approved the first statin in 1987, it required the contraindication for use in pregnant patients due to concern about the potential for fetal harm and a lack of substantial benefit to the mother. All statins approved since carry the same warning.

In reviewing data from randomized trials, meta-analyses, and observational studies, the FDA has determined that statins pose a limited risk of birth defects or miscarriage but could still potentially harm an unborn baby due to their cholesterol-lowering effects. However, there are situations in which the benefits could outweigh this risk. This includes when an expecting mother has previously had a heart attack or stroke or has a rare genetic disease known as homozygous familial hypercholesterolemia, which causes extremely high cholesterol levels.

The FDA still advises that most patients should not take statins when pregnant, and that they should not use statins if breastfeeding as the drugs might pass into the breast milk and harm the baby. According to the agency, patients taking statins should talk to their healthcare provider if they are pregnant, breastfeeding, or planning to breastfeed.

A copy of the full FDA communication can be found on the agency’s website.

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