藥物警訊

Lexiscan (regadenoson) and Adenoscan (adenosine): Drug Safety Communication - Rare but Serious Risk of Heart Attack and Death

AUDIENCE: Cardiology, Pharmacy, Radiology

ISSUE: The FDA is warning health care professionals of the rare but serious risk of heart attack and death with use of the cardiac nuclear stress test agents Lexiscan (regadenoson) and Adenoscan (adenosine). FDA has approved changes to the drug labels to reflect these serious events and updated recommendations for use of these agents. At this time, data limitations prevent FDA from determining if there is a difference in risk of heart attack or death between Lexiscan and Adenoscan.

The Warnings & Precautions section of the Lexiscan and Adenoscan labels previously contained information about the possible risk of heart attack and death with use of these drugs. However, recent reports of serious adverse events in the FDA Adverse Event Reporting System (FAERS) database and the medical literature prompted approval changes to the drug labels to include updated recommendations for use.

BACKGROUND: Lexiscan and Adenoscan are FDA approved for use during cardiac nuclear stress tests in patients who cannot exercise adequately. Lexiscan and Adenoscan help identify coronary artery disease. They do this by dilating the arteries of the heart and increasing blood flow to help identify blocks or obstructions in the heart’s arteries. Lexiscan and Adenoscan cause blood to flow preferentially to the healthier, unblocked or unobstructed arteries, which can reduce blood flow in the obstructed artery. In some cases, this reduced blood flow can lead to a heart attack, which can be fatal.

RECOMMENDATIONS: Screen all nuclear stress test candidates for their suitability to receive Lexiscan or Adenoscan. Avoid using these drugs in patients with signs or symptoms of unstable angina or cardiovascular instability, as these patients may be at greater risk for serious cardiovascular adverse reactions. Cardiac resuscitation equipment and trained staff should be available before administering Lexiscan or Adenoscan.

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 links to the Drug Safety Communication at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

FDA發布安全警訊，使用心臟核子運動壓力檢查劑Lexiscan (regadenoson)和Adenoscan (adenosine)可能會發生罕見但嚴重之心臟病發或死亡風險。FDA已核准仿單變更，告知此風險並更新使用的建議。因目前數據有限，FDA無法確認Lexiscan和Adenoscan發生心臟病發或死亡的風險差異。

先前此兩種藥品仿單之警語與注意事項欄中，即已標示可能會有心臟病發及死亡的風險，此次變更仿單與使用建議是基於近期的FDA不良反應通報系統(FAERS)及醫學相關文獻之嚴重副作用報告。

FDA核准Lexiscan和Adenoscan於無法適當運動的病人進行心臟核子運動壓力檢查時使用，其可幫助診斷冠心動脈疾病，藉由擴張心臟的動脈血管增加血流，協助找出動脈是否有阻塞。

醫療人員應審慎評估受試者是否適合使用Lexiscan或Adenoscan。患有不穩定型心絞痛或心血管相關症狀的病人因具有較高的心血管副作用風險，應避免使用此藥。在給藥前，應確認心臟復甦設備以及受訓人員可隨時支援。

相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm375981.htm