藥物警訊

Rosiglitazone-containing Diabetes Medicines: Drug Safety Communication - FDA Eliminates the Risk Evaluation and Mitigation Strategy (REMS)

AUDIENCE: Family Care, Endocrinology, Cardiology

ISSUE: FDA is eliminating the Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone-containing type 2 diabetes medicines, which are approved as Avandia, Avandamet, Avandaryl, and generics. The REMS is no longer necessary to ensure that the benefits of rosiglitazone medicines outweigh their risks.

In 2013, FDA required removal of the prescribing and dispensing restrictions for rosiglitazone medicines after determining that data did not demonstrate an increased risk of heart attack with rosiglitazone medicines compared to the standard type 2 diabetes medicines metformin and sulfonylurea. FDA also required the drug manufacturers to provide educational training to health care professionals about the current state of knowledge regarding the heart risks of rosiglitazone medicines. Manufacturers have since fulfilled these requirements.

FDA has continued monitoring these medicines and identified no new pertinent safety information. FDA will update the public if any new information becomes available.

BACKGROUND: Type 2 diabetes is a disease that can lead to serious complications such as kidney failure, blindness, and premature death. Rosiglitazone can be used along with diet and exercise to control blood sugar in adults with the disease.

RECOMMENDATION: The REMS is no longer necessary to ensure that the benefits of rosiglitazone medicines outweigh their risks.

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

美國FDA公告解除含rosiglitazone成分藥品之藥品風險評估暨管控計畫(Risk Evaluation and Mitigation Strategy, REMS)。美國FDA認為已無需進行REMS來評估含rosiglitazone成分藥品之臨床效益與風險。

2013年，依據當時研究資料顯示，與標準第二型糖尿病治療藥物metformin與sulfonylurea相比，含rosiglitazone成分藥品發生心血管疾病風險並未較高，故美國FDA取消自2010年起對於rosiglitazone的處方與使用限制，並要求廠商提供相關心血管風險之最新情況及資訊予醫療人員參考。

第二型糖尿病可能引起如腎衰竭、視力受損或死亡等併發症。Rosiglitazone可單獨使用，合併飲食及運動來達到血糖控制。經陸續的觀察及評估，由於未有新的案例發生，美國FDA公告解除對此成分藥品之REMS。美國FDA將持續監測後續狀況，若有任何更新資訊將再另行告知。

相關訊息與連結請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

[Posted 12/16/2015]

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