[Posted 07/20/2021]
Statins: Drug Safety Communication - FDA Requests Removal of Strongest Warning Against Using Cholesterol-lowering Statins During Pregnancy
AUDIENCE: Patient, Health Professional, OB/GYN, Cardiology, Endocrinology, Pharmacy
ISSUE: The FDA is requesting revisions to the information about use in pregnancy in the prescribing information of the entire class of statin medicines. 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 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.
BACKGROUND: 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. Medicines in the statin class include atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, and simvastatin.
RECOMMENDATIONS:
• Patients: Patients taking statins should notify their health care professionals if they become pregnant or suspect they are pregnant. Your health care 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.
• Health Care Professionals: Health care professionals should discontinue statin therapy in most pregnant patients, or they can consider the ongoing therapeutic needs of the individual patient, particularly those at very high risk for cardiovascular events during pregnancy. Because of the chronic nature of cardiovascular disease, treatment of hyperlipidemia is not generally necessary during pregnancy. Discuss with patients whether they may discontinue statins temporarily while breastfeeding. Advise those who require a statin because of their cardiovascular risk that breastfeeding is not recommended because the medicine may pass into breast milk.
The FDA hopes the revised language in the prescribing information will help reassure health care professionals that statins are safe to prescribe in patients who can become pregnant, and help them reassure patients with unintended statin exposure in early pregnancy or before pregnancy is recognized that the medicine is unlikely to harm the unborn baby.
Read more about the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at:
https://www.fda.gov/safety/medical-product-safety-information/statins-drug-safety-communication-fda-requests-removal-strongest-warning-against-using-cholesterol?utm_medium=email&utm_source=govdelivery
Statin類藥品為處方藥，用於降低血液中的低密度脂蛋白膽固醇（LDL-C）。Statin類藥物包括atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin及simvastatin。美國FDA要求修改statin類藥品仿單有關懷孕期間使用的資訊，包括取消有關於懷孕患者使用這類藥品的禁忌症(禁忌症是美國FDA最強烈的警告，只有因風險顯然超過任何可能的好處，不應使用藥物時才會標示為禁忌症)。因為statin類藥物對於少部分有極高心血管疾病風險的孕婦，其可能擁有預防嚴重或可能致命事件的益處，所以這類藥品禁用於所有孕婦並不合適。
美國FDA預計取消此懷孕禁忌症，可使醫療專業人員和患者能夠就利益和風險做出個人決定，特別是對於有發生心臟病或中風的高危險病人，包括患有同合子家族性高膽固醇血症的患者和以前曾有過心臟病發作或中風的患者。
建議：
病人：服用statin類藥物的患者如果懷孕或懷疑懷孕，應告知其醫療專業人員。醫療專業人員會再行建議病人是否應在懷孕期間停止服用該藥，及是否在哺乳期間暫時停止服用statin類藥物。產後需服用statin類藥物的心臟病或中風高危險患者不應哺乳，而應使用嬰兒配方奶粉等替代品。
醫療專業人員：多數懷孕病人應停止statin類藥物治療，特殊情況或可考慮持續治療，尤其心血管事件風險非常高的懷孕病人。由於心血管疾病為慢性病，懷孕期間通常不需要治療高血脂。Statin類藥品可能會分泌至乳汁中，服用statin類藥品的人不建議哺乳，或建議哺乳期間暫停使用statin類藥物。
美國FDA希望仿單修訂後有助於讓醫療專業人員放心，statin類藥物在可能懷孕的患者中是安全的，並幫助他們讓懷孕早期或懷孕前意外接觸statin類藥物的患者放心，因為此時期接觸statin類藥物不太可能傷害未出生的嬰兒。
更多相關訊息與連結請參考FDA網址：https://reurl.cc/O0l9a3
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部
回首頁 |
