FDA requests removal of strongest warning against statin use among pregnant women
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The FDA requested removal of its contraindication against using cholesterol-lowering statin medicines among pregnant patients; however, most patients should stop statins once they learn they are pregnant.
A contraindication is the FDA’s strongest warning and only added when a medicine should not be used due to risk that outweighs any possible benefit.
According to an FDA press release, statins may prevent major adverse events among certain high-risk patients who are pregnant; therefore, contraindicating statin therapy for all pregnant women is not appropriate.
The FDA added that patients who are breastfeeding should halt statin therapy, as the drug may pass into breast milk and pose a risk to the baby, and many can resume treatment when breastfeeding ends.
According to the release, patients requiring ongoing statin therapy should not breastfeed and instead use infant formula or other alternatives.
“FDA expects 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,” the FDA wrote in a drug safety communication. “This includes patients with homozygous familial hypercholesterolemia and those who have previously had a heart attack or stroke. Statins are safe to use in patients who are not pregnant but may become pregnant.”
Perspective
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Kathryn J. Lindley, MD, FACC
This is an excellent recommendation by the FDA, and it gives clinicians more flexibility to treat complex pregnant women. The prior recommendation for statins to be absolutely contraindicated is based off of very early case series and animal studies, though subsequent cohort studies and meta-analyses have not shown evidence of fetal harm. While statin use is commonly used for long-term benefit in this age group of patients (for example, those with familial hyperlipidemia), there are higher-risk patients, including those with existent CAD, for whom statin therapy during pregnancy may provide more benefit than harm. This change in FDA recommendation permits more room for individualized patient care in pregnant and lactating women.
As always, it is important to individualize patient care, discussing the potential risks and benefits of both treatment and withholding treatment, as well as the limitations of our knowledge. After discussing these options with patients, I would consider treatment of the highest-risk patients with statin therapy during pregnancy and lactation, if the patient also felt comfortable with this treatment plan. In particular, more hydrophilic statins, including rosuvastatin and pravastatin may be the safest options for pregnant and lactating women, so I would typically recommend those medication choices in this situation.
It will be particularly important to continue to obtain observational data moving forward now that more women may be prescribed statin therapy during pregnancy and lactation, so we can develop a greater knowledge base about the risks and benefits to both mom and baby. It is always important to remember that optimizing maternal health — in this case through limiting coronary or cerebral ischemia — is the best way to end up with an optimal fetal outcome as well.
It will also continue to be exceptionally important moving forward to enroll women of childbearing age, including pregnant and lactating women, in clinical trials so that we can develop a higher quality understanding of the safety and potential benefit of all CV therapies in this complex, but not vulnerable, patient population. That is the best way to deliver the highest quality care to both women and their infants over the long run.
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