Public Alert No.027/2021- Statins: Drug Safety Communication – US Food And Drug Administration (FDA) Requests Removal Of Strongest Warning Against Using Cholesterol-Lowering Statins During Pregnancy
August 9, 2021,
The National Agency for Food and Drug Administration and Control (NAFDAC) has been informed by the U.S FDA about revisions to the prescribing information of the entire class of statin medicines, regarding their use in pregnancy. These changes include removing the contraindication against using these medicines in all pregnant patients. A contraindication is FDA’s strongest warning and is only added when a medicine should not be used because the risk clearly outweighs any possible benefit. 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.
FDA expects that 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. 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.
Statins are a class of prescription medicines that have been used for decades to lower low-density lipoprotein (LDL-C or “bad”) cholesterol in the blood. Statins work by reducing the amount of cholesterol made by the liver and helping the liver remove cholesterol already in the blood. Statins also can lower the risk for heart attack and stroke in those who have heart disease or risk factors for it. These medicines may help stabilize the plaques that can build up inside blood vessel walls, which can interfere with blood flow to the heart and brain, leading to heart attack and stroke.
Medicines in the statin class include atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, and simvastatin.
NAFDAC advice Patients taking statins to notify their health care providers on their pregnancy status. The health care provider will be able to advise on whether the patient should discontinue the use of the medication during pregnancy, or discontinue 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.
Health professionals and patients are encouraged to report adverse events or quality problems experienced with the use of these medicines to the nearest NAFDAC office, NAFDAC PRASCOR [20543 or 0800-1-NAFDAC (0800-1-623322) TOLL FREE from all networks] or via firstname.lastname@example.org or via eReporting platform available on the NAFDAC website www.nafdac.gov.ng or via Med Safety Application available for download on Android and IOS stores.