Unsafe Drugs Now Safe? FDA's Request to Change Statin Warning in Pregnancy

Unsafe Drugs Now Safe? FDA's Request to Change Statin Warning in Pregnancy
Ryan Albrecht, PharmD, Coborn’s CSC

Statins, HMG-CoA reductase inhibitors, have revolutionized the way we treat hyperlipidemia. However, since the first statin, lovastatin, hit the market in 1987 there has been a warning attached to the class to avoid use in pregnancy. That warning was given by the US Food and Drug Administration (FDA) based on animal studies linking statin use to birth defects and the belief that short-term use of statins in pregnancy would not provide substantial benefit of preventing cardiovascular disease in mothers. Manufacturers have since included this warning as a contraindication for all statins. Now, 34 years later, the FDA is changing its stance and recommending the removal of this contraindication for all statins. The reason behind this new recommendation, according to the FDA’s Drug Safety Communication from July 20, 2021, is the overwhelming amount of evidence showing a benefit of statin use in preventing cardiovascular events. In addition, they cite a lack of data from published studies showing a link between statin use and birth defects. The FDA believes that removal of the contraindication will allow for an individualized approach to statin therapy in pregnant patients. It is still recommended that most patients be taken off statins during pregnancy, but those at very high-risk for stroke or heart attack may benefit from continuation of therapy. With this change, the FDA urges that side effects be reported using the MedWatch program. Due to the small number of very high-risk pregnant patients that this change targets, it is unlikely that this recommendation by the FDA will widely change statin prescribing. However, it is reassuring that data driven changes are being made to ensure individualized patient therapy.



  1. U.S. Food & Drug Administration. FDA Drug Safety Communication. FDA.gov. https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-remo.... Published July 20, 2021. Accessed July 23, 2021.
  2. U.S. Food & Drug Administration. MedWatch Online Voluntary Reporting Form. FDA.gov. https://www.accessdata.fda.gov/scripts/medwatch/. Accessed July 23, 2021.