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Aliskiren-containing Medications: Drug Safety Comunication - New Warning and Contraindication
including:
● Amturnide (aliskiren hemifumarate, amlodipine besylate, and hydrochlorothiazide)
● Tekturna (aliskiren hemifumarate)
● Tekturna HCT (aliskiren hemifumarate and hydrochlorothiazide)
● Tekamlo (aliskiren hemifumarate and amlodipine besylate)
● Valturna (aliskiren hemifumarate and valsartan). Valturna will no longer be marketed after July 2012
AUDIENCE: Internal Medicine, Pharmacy, Endocrinology
ISSUE: [Posted 04/20/2012]FDA notified healthcare professionals of possible risks when using blood pressure medicines containing aliskiren with other drugs called angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) in patients with diabetes or kidney (renal) impairment. These drug combinations should not be used (are contraindicated) in patients with diabetes. In addition, avoid use of aliskiren with ARBs or ACEIs in patients with moderate to severe renal impairment (i.e., where glomerular filtration rate [GFR] < 60 mL/min). The labels for the aliskiren drugs are being updated based on preliminary data from a clinical trial, “Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE).”
BACKGROUND: Aliskiren is a renin inhibitor used to treat high blood pressure (hypertension) by lowering blood pressure.
RECOMMENDATION: Concomitant use of aliskiren with ARBs or ACEIs in patients with diabetes is contraindicated because of the risk of renal impairment, hypotension, and hyperkalemia. Avoid use of aliskiren with ARBs or ACEIs in patients with renal impairment where GFR < 60 mL/min. Patients should not stop taking aliskiren without talking to your healthcare professional. Stopping aliskiren suddenly can cause problems if your high blood pressure (hypertension) is not treated.
See the Drug Safety Communication for the Data Summary, a list of?ACEI and ARB products, and additional recommendations for healthcare professionals and patients.
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，糖尿病病人禁止併用絡舒樂適膜衣錠（aliskiren）與angiotensin converting enzyme inhibitors (ACEIs)或angiotensin receptor blockers (ARBs)，因為可能增加腎損傷、低血壓及高血鉀的風險。另外中重度腎功能不全(GFR<60 mL/min)的病人，也應避免併用aliskiren與ACEIs或ARBs。這些資訊是基於”Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE)”試驗而來，目前正將相關資訊。
更新至aliskiren仿單
建議正在服用aliskiren的病人，不應在未諮詢醫療人員前任意停藥，因為可能會使得血壓無法得到有效的控制。其它詳細資訊請見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/ucm301120.htm
[Posted 04/20/2012]
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
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資料來源：藥師週刊（第1773期）
