關於pioglitazone (Actos®)及雙膦酸鹽(bisphosphonates)安全性的最新資訊 Latest safety updates on pioglitazone (Actos®) and bisphosphonates

Pioglitazone (Actos®)疑增膀胱癌風險

    近期一項關於Actos®安全性的流行病學研究的中期報告指出, 長期服用Actos®以及處於最大累積劑量的病人可能增加患上膀胱癌的風險, 有關研究仍繼續進行, 藥物監測暨管理處正密切留意該藥的安全性。

    現階段藥物監測暨管理處提醒醫生依照藥物說明書的建議處方該藥, 並教育病人在沒有醫生的指導下, 不要自行停藥, 病人如對所服用的藥物有任何疑問, 應諮詢醫生﹑藥劑師或其他衛生專業人士的意見。

 

雙膦酸鹽(bisphosphonates)與大腿骨折

     基於近期美國骨科學會(ASBMR)專家小組發表的一份研究報告, 美國食物及藥物管理局(USFDA)指出, 長期服用bisphosphonates的病人, 可能出現罕見﹑不尋常且嚴重的股骨折(大腿骨折)。雖然該類藥物可有效減少病人因骨質疏鬆所造成的普通骨折, 然而並不清楚為何bisphosphonates會與大腿骨折這類罕見的骨折有關。上述因果關係尚待研究證實, 藥物監測暨管理處提醒醫生嚴格依照藥物說明書處方bisphosphonates, 並且監測病人可能出現的不尋常骨折。醫生及其他衛生專業人士應告知病人, 在沒有醫生許可下, 不應自行停藥, 如服藥過程中感到髖部、大腿或腹股溝部位出現疼痛, 又或對所服用的藥物有任何疑問, 應諮詢主診醫生的意見

 

*備註:含有bisphosphonates 的藥物包括Actonel®﹑Actonel+Ca®﹑Aredia®﹑Boniva®﹑Didronel®﹑Fosamax®﹑Fosamax+D®﹑Reclast®﹑Skelid® 以及 Zometa®

                                                                                                                                                                                                                                                                   

Pioglitazone (Actos®) and possible increased risk of bladder cancer

    Observation from an ongoing safety study indicated Actos® may be associated with an increased risk of bladder cancer especially among patients with the longest exposure to and/or the highest culmulative dose of Actos®. The study is still under investigation. DFF is paying close attention to the safety of Actos®.

    At this moment, DFF advises prescribers to follow the recommendations in the drug label when prescribing Actos®. Instruct your patients not to stop taking their medicine unless told by their physicians and talk to physicians, pharmacists or other healthcare professionals if they have any concerns with the medication he/she is taking.

 

Bisphosphonates and possible thigh bone fracture

    Based on the report from the American Society of Bone and Mineral Research’s (ASBMR) expert Task Force, United States Food and Drugs Administration(USFDA) announced about the possible increased risk of a rare, unusual but severe femur (thigh bone) fractures in patients taking long-term oral bisphosphonates. Though this class of medications has been effective in reducing common bone fractures in individuals with osteoporosis, it is unclear why bisphosphonates are involved with the development of this rare fracture. While the issue is still under investigation, DFF advises physicians to follow the recommendations in the drug label when prescribing bisphosphonates and be vigilant of the possible risk of unusual femur factures in patients. The following information should be communicated to the patients: not to stop taking their medication unless under medical advice and notify their physicians if they develop new hip or thigh or groin pain or have any concerns with their medications.

 

*Brand names of medicines containing biphosphonates include Actonel®, Actonel+Ca®, Aredia®, Boniva®, Didronel®, Fosamax®, Fosamax+D®, Reclast®, Skelid®, and Zometa®.

 

參考資料/References and websites:

https://www.fda.gov/Drugs/DrugSafety/ucm226214.htm

https://www.fda.gov/Drugs/DrugSafety/ucm225681.htm


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