Statins and Pregnancy: FDA Changes Message

FDA plans to revise recommendations about statin use during pregnancy

(RxWiki News) For a long time, doctors have been advised not to prescribe statins to any pregnant patient. Soon, that advice might change.

That's because the US Food and Drug Administration (FDA) announced that it is seeking to change a blanket contraindication for statins in all pregnant patients.

A contraindication is the FDA's most serious type of warning. It means a drug should not be used in a particular group at all because the risks outweigh the benefits.

But now, the FDA is saying that statins, which lower cholesterol, may prevent potentially fatal events in some pregnant women. And that suggests that a contraindication for all pregnant women may not be appropriate.

The FDA said in a public statement that "... removing the contraindication will enable health care professionals and patients to make individual decisions about benefit and risk, especially for those at very high risk of heart attack or stroke."

Statins are a broad category of medications that lower cholesterol. Some common statins include fluvastatin, atorvastatin, lovastatin, pitavastatin, pravastatin, simvastatin and rosuvastatin.

While the FDA is planning to change its recommendations about statins and pregnancy, it maintained that patients should take precautions to prevent possible complications involving these drugs.

For example, the FDA noted that anyone who is taking statins and becomes pregnant should tell their health care providers right away. The agency also said that patients who have to take statins after giving birth should use infant formula or a similar replacement for breastfeeding.

The FDA said it hopes that the revised prescribing information "... will help reassure health care professionals that statins are safe to prescribe in patients who can become pregnant, and help them reassure patients with unintended statin exposure in early pregnancy or before pregnancy is recognized that the medicine is unlikely to harm the unborn baby."

If you are pregnant or planning to become pregnant, talk to your health care provider about which medications are safe to take.

Reviewed by: 
Review Date: 
August 3, 2021