FDA New Warning For Statin Use In Pregnancy
The FDA is requesting removal of its strongest warning against using cholesterol-lowering statin medicines in pregnant patients. Despite the change, most patients should stop statins once they learn they are pregnant. They have conducted a comprehensive review of all available data and make a change to the prescribing information as part of FDA’s ongoing effort to update the pregnancy and breastfeeding information for all prescription medicines.
FDA also re-reviewed nonclinical data from statin development programs. The totality of the data suggests a limited potential for statins to cause malformations or embryofetal lethality, and limited potential to affect nervous system development during human embryofetal development and during the pre- and post-natal period.
Patients should not breastfeed when taking a statin because the medicine may pass into breast milk and pose a risk to the baby. Many can stop statins temporarily until breastfeeding ends. However, patients requiring ongoing statin treatment should not breastfeed and instead use infant formula or other alternatives.
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