On July 20, 2021, the U.S. FDA published a notice on its website revising the instructions to “remove the strongest warning (contraindication) for the use of statins during pregnancy, but still recommend that most pregnant women should discontinue these drugs and do not recommend breastfeeding for patients using statins“.
Reasons for the revised instructions
The FDA requested that the strongest warning – a contraindication – for the use of cholesterol-lowering statins in pregnant women be removed. The FDA panel conducted a comprehensive review of the data and concluded that there may be potential benefits of statins in “preventing serious or potentially fatal events in a small subset of high-risk pregnant women” and that the previous “complete ban on these drugs in all pregnant women” needs to be adjusted.
The FDA believes that eliminating contraindications will allow health care professionals and patients to make individualized decisions about benefits and risks, particularly for those with very high episodes or risks (including pure-sibling familial patients and those with a prior history of heart attack or stroke onset).
Additional recommendations for clinical use of the drug
Statins are safe for use in patients who are preparing for pregnancy.
Most patients should stop taking statins when they learn they are pregnant.
Patients taking statins should not breastfeed because the drug may pass into breast milk and pose a risk to the infant. Most people can stop taking statins temporarily until breastfeeding is over.
Patients who need to continue treatment with statins should not breastfeed and should use infant formula or other alternatives.
Statins, including, fluvastatin,pitavastatin, pravastatin, resevastatin, simvastatin, and combination formulations, are a class of medications used to lower blood cholesterol levels by reducing the cholesterol produced by the liver and helping the liver to remove cholesterol already in the blood.
Statins may also reduce the risk of heart attacks and strokes in patients with heart disease or related risk factors. These drugs may help stabilize plaque that builds up in the walls of blood vessels (plaque interferes with blood flow to the heart and brain, leading to heart attacks and strokes).
Common side effects include headache, nausea, muscle pain, diarrhea, and constipation.