| Birth Control Pills Containing Drospirenone: Possible Increased Risk of Blood Clots
AUDIENCE: OBGYN, Family Practice, Patient
FDA is aware of two newly published studies that evaluated the risk of venous thromboembolism (VTE) in women who use birth control pills that contain drospirenone. The two recently published studies looked at whether there is a higher risk of blood clots in women taking birth control pills containing the progestin drospirenone when compared to similar women taking birth control pills containing a different progestin called levonorgestrel. These two new studies reported that there is a greater risk of VTE associated with birth control pills that contain drospirenone. This risk is reported to be up to 2 to 3 times greater than the risk of VTE associated with using levonorgestrel-containing pills. Other studies have not reported an increase in risk. The FDA is currently evaluating the conflicting results from these studies and will look at all currently available information to fully assess the risks and benefits of drospirenone-containing birth control pills. FDA will continue to communicate any new safety information to the public as it becomes available. Read the drug safety communication for more information on these studies.
BACKGROUND: Drospirenone is a type of female sex hormone called a progestin. Most birth control pills contain two types of hormones--estrogen and progestin. Birth control pills work by preventing the release of eggs from the ovaries (ovulation) and changing the cervical mucus and the lining of the uterus to prevent pregnancy. Brand names of drospirenone-containing products include Yaz (generics Gianvi and Loryna), Yasmin (generics Ocella, Syeda, and Zarah), Beyaz, and Safyral.
RECOMMENDATION: If your birth control pill contains drospirenone, do not stop taking it without first talking to your healthcare professional. Contact your healthcare professional immediately if you develop any symptoms of blood clots, including persistent leg pain, severe chest pain, or sudden shortness of breath. If you smoke and are over 35 years of age, you should not take combination oral contraceptives because they increase the risk that you could experience serious cardiovascular events, including blood clots.
FDA注意到最近發表的兩個研究，是評估婦女使用含有drospirenone的避孕藥後，可能會引發靜脈血栓栓塞(venous thromboembolism, VTE)的風險。研究內容為比較婦女服用含有drospirenone或levonorgestrel的避孕藥後，其產生血栓的機率。報告結果指出，服用含有drospirenone成分的避孕藥導致VTE的風險，較服用levonorgestrol成分的避孕藥高出2~3倍。而其他的研究報告並沒有顯示增加這個風險。FDA目前正在評估這些研究結果之間的差異，並會參考所有現有的資料，以充分評估含drospirenone成分避孕藥的風險及效益價值。 FDA會持續向大眾提出新的用藥安全資訊。
Drospirenone是女性荷爾蒙中孕激素(progestin)的一種，大多數的避孕藥都包含兩種荷爾蒙分別是雌激素和孕激素，避孕藥的功用是抑制排卵、改變子宮頸粘液和子宮內膜，以避免懷孕。含有drospirenone的藥品名稱有：Yaz (generics Gianvi and Loryna), Yasmin (generics Ocella, Syeda, and Zarah), Beyaz, and Safyral。
如果你所服用的避孕藥含有drospirenone，在詢問專業醫療人士之前，請先不要停用。如果出現任何血栓的症狀，包含持續性腿部疼痛，嚴重的胸疼，或突然呼吸急促，請立即連絡專業的醫療人員。如果你會抽煙且年齡超過35歲以上，請不要服用口服避孕藥，因為口服避孕藥會導致更嚴重的心血管疾病，包含血栓。
相關訊息與連結請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm257337.htm
[Posted 05/31/2011]
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 |
資料來源：藥師週刊（第1738期）