藥物警訊（藥師週刊第1765期）

Statins and HIV or Hepatitis C Drugs: Drug Safety Communication - Interaction Increases Risk of Muscle Injury

AUDIENCE: Infectious Disease, Family Practice, Patients

ISSUE: FDA notified healthcare professionals of updates to the prescribing information concerning interactions between protease inhibitors and certain statin drugs. Protease inhibitors and statins taken together may raise the blood levels of statins and increase the risk for muscle injury (myopathy). The most serious form of myopathy, called rhabdomyolysis, can damage the kidneys and lead to kidney failure, which can be fatal.

BACKGROUND: Statins are a class of prescription drugs used together with diet and exercise to reduce blood levels of low-density lipoprotein (LDL) cholesterol (“bad cholesterol”). HIV protease inhibitors are a class of prescription anti-viral drugs used to treat HIV. HCV protease inhibitors are a class of prescription anti-viral drugs used to treat hepatitis C infection.

RECOMMENDATION: Healthcare professionals should follow the recommendations in the prescribing information ( drug labels ) when prescribing HIV or HCV protease inhibitors with statins. See the FDA Drug Safety Communication for additional information, including a data summary.

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/SafetyAlertsforHuma...

FDA提醒醫療人員某些statin會與protease inhibitor的藥品產生交互作用，當同時服用時，可能會增加statin的血中濃度，提高肌肉損傷的風險，最嚴重的情況（即橫紋肌溶解）可能導致腎衰竭，甚至致死。

Statin這類藥品合併飲食控制及運動，可用於降低密度脂蛋白(low-density lipoprotein; LDL)，而HIV protease inhibitor與HCV protease inhibitor則分別用於治療HIV及C型肝炎。

建議醫療人員需同時處方protese inhibitor與statin藥品時，應遵照藥品仿單建議給藥。詳細資訊請見FDA網站上Drug Safety Communication。
相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation /SafetyAlertsforHumanMedicalProducts/ucm294294.htm
[Posted 03/01/2012]

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