FDA pushes for statin warnings to be updated
The FDA has announced that it is urging pharmaceutical companies to change the warnings they include with all statin medications.
Ever since the first statin gained FDA approval back in 1987, the cholesterol-lowering medications have always included a warning that said they should never be used by patients who are pregnant or breastfeeding. The agency still believes that clinicians should not prescribe statins to pregnant or breastfeeding patients in most instances—however, additional research has confirmed that exceptions do exist.
For instance, statin use may help pregnant or breastfeeding patients who face an especially high risk of significant cardiovascular complications.
“Because the benefits of statins may include prevention of serious or potentially fatal events in a small group of very high-risk pregnant patients, contraindicating these drugs in all pregnant women is not appropriate,” according to a detailed statement on the FDA’s website. “FDA expects removing the contraindication will enable healthcare professionals and patients to make individual decisions about benefit and risk, especially for those at very high risk of heart attack or stroke. This includes patients with homozygous familial hypercholesterolemia and those who have previously had a heart attack or stroke.”
The FDA also emphasized that statin use is perfectly safe for patients who may go on to become pregnant. Unintentional statin exposure “in early pregnancy or before pregnancy is recognized” is not considered a risk to the unborn baby.
So, what should patients do in the face of this latest recommendation? According to the FDA, the key is communication.
“Patients taking statins should notify your healthcare professionals if you become pregnant or suspect you are pregnant,” the agency wrote. “Your healthcare professional will be able to advise whether you should stop taking the medicine during pregnancy and whether you may stop your statin temporarily while breastfeeding. Patients who are at high risk of heart attack or stroke who require statins after giving birth should not breastfeed and should use alternatives such as infant formula.”
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.