藥物警訊

Rosiglitazone-containing Diabetes Medicines: Drug Safety Communication - Removal of Some Prescribing and Dispensing Restrictions

including Avandia, Avandamet, Avandaryl, and generics

AUDIENCE: Family Care, Endocrinology, Cardiology

ISSUE: FDA has determined that recent data for rosiglitazone-containing drugs, such as Avandia, Avandamet, Avandaryl, and generics, do not show an increased risk of heart attack compared to the standard type 2 diabetes medicines metformin and sulfonylurea. As a result, FDA is requiring removal of the prescribing and dispensing restrictions for rosiglitazone medicines that were put in place in 2010. This decision is based on FDA review of data from a large, long-term clinical trial and is supported by a comprehensive, outside, expert re-evaluation of the data conducted by the Duke Clinical Research Institute (DCRI).

Previous data from a large, combined analysis of mostly short-term, randomized clinical trials of rosiglitazone had suggested an elevated risk of heart attack, so FDA required a Risk Evaluation and Mitigation Strategy (REMS), called the Rosiglitazone REMS program. The Rosiglitazone REMS program restricted the use of rosiglitazone medicines to help ensure that their benefits outweighed the risks.

Although some scientific uncertainty about the cardiovascular safety of rosiglitazone medicines still remains, in light of the new re-evaluation of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial, FDAs concern is substantially reduced and the rosiglitazone REMS program requirements will be modified. FDA is also requiring revisions to the rosiglitazone prescribing information and the patient Medication Guide to include this new information.

Refer to the Drug Safety Communication for more details.

BACKGROUND: Rosiglitazone is a treatment option that can improve blood sugar control in some patients with type 2 diabetes.

RECOMMENDATION: Patients with type 2 diabetes should continue to work closely with their health care professionals to determine treatment options that are most appropriate. Health care professionals, pharmacies, and patients will no longer be required to enroll in the rosiglitazone REMS program to be able to prescribe, dispense, or receive rosiglitazone medicines. As part of the REMS, sponsors will ensure that health care professionals who are likely to prescribe rosiglitazone medicines are provided training based on the current state of knowledge concerning the cardiovascular risk of rosiglitazone medicines. Manufacturers will also send Dear Healthcare Provider and Dear Professional Society letters to educate prescribers about the new information.

Read the MedWatch safety alert, including links to the FDA Drug Safety Communications, at

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

FDA公告含rosiglitazone成分藥品如Avandia、Avandamet、Avandaryl以及其學名藥，與標準第二型糖尿病治療藥物metformin與sulfonylurea相比，其發生心血管疾病風險並未較高。FDA將取消自2010年起對於rosiglitazone的處方與使用限制。

先前FDA綜合許多短期隨機之臨床試驗分析，認為rosiglitazone會增加心臟病發的風險，故FDA要求進行rosiglitazone之風險評估暨管控計畫(REMS)，設定rosiglitazone的使用限制，以確保服用者之利益大於風險。

雖rosiglitazone於心血管之安全性仍然存在不確定性，但FDA根據 RECORD (Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes)試驗的再評估報告後，已大幅減少對於此藥之顧慮，且將修改rosiglitazone之管控計畫。

背景：Rosiglitazone為改善第二型糖尿病病人的血糖控制藥物之一。

建議：罹患有第二型糖尿病之病人應持續與醫療人員討論以決定最適當的治療用藥。醫療人員、藥局和病人將不再受限於rosiglitazone之REMS計畫，可開立、調劑與使用rosiglitazone。廠商應函知醫療機構及專業學會，俾利開方醫師了解此類藥品與心血管疾病風險之最近現況與資訊。

相關訊息與連結請參考FDA網址：

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

[Posted 11/26/2013]

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