Is statin therapy safe for pregnant women?
The long-standing prohibition on statin use during pregnancy has been reconsidered, opening the door for broader clinical discussions between cardiologists and expectant mothers. Laxmi Mehta, MD, a professor of medicine and section director of preventative cardiology and women's cardiovascular health at The Ohio State University Wexner Medical Center, emphasized the importance of these conversations in an interview with Cardiovascular Business.
For years, statins carried a U.S. Food and Drug Administration (FDA) "black box" warning due to concerns about teratogenicity based on animal studies involving rats and rabbits, which showed potential congenital malformations. However, human studies have since provided more clarity. While some data indicate possible associations with low birth weight or preterm labor, congenital malformations have not been confirmed as a significant risk factor in statin-exposed pregnancies. The FDA lifted the black box warning on statins in 2021.
With the increasing prevalence of maternal obesity and rising age of pregnancy, the cardiovascular health among women of childbearing age has become a growing concern. Mehta highlighted that atherosclerotic cardiovascular disease (ASCVD) affects approximately 1.4% of women in this demographic. Additionally, familial hypercholesterolemia (FH), a genetic condition impacting cholesterol levels, is underdiagnosed and undertreated in women, further necessitating effective lipid management strategies.
"They need statin therapy. These women need to improve their overall cardiovascular health and prevent events," Mehta explained.
She said the regulatory change underscores the necessity of shared decision-making between clinicians and patients.
"If a patient has a preexisting cardiovascular condition, we don't need to say, 'no, you can't get pregnant because you can't be on a statin.' We can say, 'let's work with you and we can do it,'" Mehta explained.
This shift in approach allows for individualized care plans, particularly for patients with severe lipid disorders such as homozygous FH. The emphasis now is on informed discussions that consider the benefits of statin therapy against potential risks, ensuring that women are not unduly discouraged from pregnancy due to cardiovascular concerns.
Ultimately, she said the medical community is moving towards a more nuanced understanding of statins in pregnancy, allowing for better treatment options and improved maternal and fetal outcomes.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: dfornell@innovatehealthcare.com