關於含有drospirenone的口服避孕藥安全性的最新資訊 Latest safety update on drospirenone-containing oral contraceptives

 

      近期兩篇發表於英國醫學雜誌的研究指出, 相對於服用含levonorgestrel口服避孕藥的婦女, 服用drospirenone口服避孕藥的女性, 出現靜脈血栓栓塞性事件(如深部靜脈栓塞和肺栓塞)的風險高出兩至三倍。Drospirenone是一種孕激素, 與雌激素組成複方製劑用作口服避孕藥。美國食物及藥物管理局(USFDA)正評估這些研究的結果, 以衡量含drospirenone口服避孕藥的風險及效益。目前, 藥物監測暨管理處建議醫生﹑藥劑師及其他衛生專業人士:

1.  嚴格按照藥物說明書處方含有drospirenone的口服避孕藥;

2.  與病人討論含drospirenone口服避孕藥的效益及潛在的風險;

3.  教導病人認識深部靜脈栓塞和肺栓塞的症狀, 如出現相關症狀時, 應立即求診

 

備註:獲准在本澳市場供應含有drospirenone的口服避孕藥包括Angeliq Tab﹑Yasmin Tab以及Yaz Tab。

 

      Two recent articles in the British Medical Journal reported a two to three fold greater risk of venous thromboembolic events (VTE, such as deep vein thrombosis (DVT) and pulmonary embolism (PE)) in women using oral contraceptives containing drospirenone rather than levonorgestrel. Drospirenone is a type of progestin used in combination with an estrogen in oral contraceptives. The United Food and Drug Administration (USFDA) is evaluating the conflicting results from these studies to fully assess the risks and benefits of drospirenone-containing birth control pills. Currently, Division of Pharmacovigilance and would like to advise physicians, pharmacists and health professionals that:

1.  continue to follow the recommendations in the drug labels when prescribing oral contraceptive products that contain drospirenone;

2.  discuss the known benefits and potential risks of drospirenone-containing products with your patients;

3.  educate your patients to recognize the signs and symptoms of DVT and PE, and tell them to immediately contact their physician if they develop any of these symptoms.

 

Note:The drospirenone-containing oral contraceptives authorized for distribution in the Macao market include Angeliq Tab, Yasmin Tab and Yaz Tab.

 

參考資料/References and websites:

https://www.fda.gov/Drugs/DrugSafety/ucm257164.htm


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