藥物警訊（藥師週刊第1770期）

Birth Control Pills Containing Drospirenone: Label Change-Products may be associated with a higher risk for blood clots

AUDIENCE: OBGYN, Family Practice, Patient

ISSUE: FDA has completed its review of recent observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills. Based on this review, FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills.

BACKGROUND: Drospirenone is a synthetic version of the female hormone, progesterone, also referred to as a progestin. FDA is adding information about the studies to the labels of drospirenone-containing birth control pills.

The revised drug labels will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products. The labels also will include a summary of the previously released results of an FDA-funded study of the blood clot risk.

RECOMMENDATION: Women should talk to their healthcare professional about their risk for blood clots before deciding which birth control method to use.

Healthcare professionals should consider the risks and benefits of drospirenone-containing birth control pills and a woman's risk for developing a blood clot before prescribing these drugs.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

* Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

* Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm299605.htm

FDA已完成『近期婦女服用含drospirenone的避孕藥產生血栓風險的觀察性研究』之評估，結論為含drospirenone的避孕藥，相較於含其他黃體素的避孕藥，有較高的血栓風險。

Drospirenone是種合成的黃體素，有些研究顯示，含drospirenone的避孕藥，相較於含其他黃體素的避孕藥，其血栓風險為3倍，然而， 其他研究卻無顯示有較高的血栓風險。FDA正在更新含drospirenone避孕藥的仿單相關資訊。

建議婦女在選擇避孕方式時，應先諮詢醫療人員關於血栓的風險，而醫療人員在處方含drospirenone避孕藥前，應先評估使用的利與弊及病人產生血栓的風險。

相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation /SafetyAlertsforHumanMedicalProducts/ucm299605.htm
[Posted 04/10/2011]

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