其 他 安 全 警 示
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| The United States: Statins: Drug Safety Communication - FDA Requests Removal of Strongest Warning Against Using Cholesterol-lowering Statins During Pregnancy (English only) |
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The United States Food and Drug Administration (FDA) announces that it 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. Medicines in the statin class include atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, and simvastatin.
FDA also advises healthcare professionals that they 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. Healthcare professionals should also discuss with patients whether to discontinue statins temporarily while breastfeeding. They should advise patients who require a statin because of their cardiovascular risk, that breastfeeding is not recommended because the medicine may pass into breast milk.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/medical-product-safety-information/statins-drug-safety-communication-fda-requests-removal-strongest-warning-against-using-cholesterol
In Hong Kong, there are 286 registered pharmaceutical products containing statins (i.e. atorvastatin, fluvastatin, lovastatin, rosuvastatin, pravastatin, simvastatin) and they are all prescription-only medicines. So far, the Department of Health (DH) has received 26 cases of adverse drug reaction with statins, but none of them are related to pregnancy. The DH will remain vigilant on any further safety updates of statins issued by overseas drug regulatory authorities.
Ends/ Wednesday, July 21, 2021
Issued at HKT 17:30
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