Oral Bisphosphonates: Ongoing Safety Review of Atypical Subtrochanteric Femur Fractures
Audience: Orthopedic healthcare professionals, patients
FDA notified healthcare professionals and patients that at this point, the data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures. FDA is working with outside experts, including members of the recently convened American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather more information and evaluate the issue further.
FDA recommends that healthcare professionals follow the recommendations in the drug label when prescribing oral bisphosphonates.
Patients should continue taking oral bisphosphonates unless told by their healthcare professional to stop. Patients should talk to their healthcare professional if they develop new hip or thigh pain or have any concerns with their medications.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
FDA通知醫療人員和病人關於FDA重新審閱bisphosphonate的相關文獻,但並無法證明使用bisphosphonate和發生非典型股骨轉子骨下骨折(subtrochanteric femur fractures)之間有明確的關聯。FDA正與相關的專家,American Society of Bone and Mineral Research (ASBMR)之Subtrochanteric Femoral Fracture Task Force合作,待收集更多資料後再進一步評估。
FDA提醒醫護人員,為病人處方口服之bisphosphonate相關藥品時,應遵照藥品仿單上的建議。
使用該類藥品之病人應繼續服用,除非醫護人員告知需停藥。如有發生臀部或大腿疼痛的現象或任何與藥品相關之問題時,病人應立即與醫護人員聯絡。
相關訊息請參考FDA網址:http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm204127.htm
[Posted 03/11/2010]
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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