關於ketoprofen外用製劑安全性的最新資訊 Latest safety update on topical ketoprofen

        Ketoprofen是一非甾體抗炎藥(NSAID), 可供外用以緩解由輕微創傷﹑肌腱炎﹑小關節骨關節炎﹑靜脈炎和腰部疾病引起的急性﹑局部疼痛或炎症, 歐盟藥物管理局(EMA)對於局部使用ketoprofen的外用製劑可能引起皮膚光過敏反應作出風險評估, 並指出該藥引起嚴重光過敏反應的機率非常小, 而且可通過適當措施減低該風險。雖然使用ketoprofen的外用製劑的效益仍高於其風險, EMA仍建議醫生﹑藥劑師及其他衛生專業人士:

  • 須注意ketoprofen外用製劑具有引起光過敏反應的風險;
  • 告知病人如何適當地使用ketoprofen的外用製劑;
  • 確保病人知悉下列資訊:

i)   確保於整個治療期間及治療結束後兩星期, 接受治療的部位不會受到太陽光照射;

ii)  於每次使用ketoprofen後, 仔細地清潔雙手;

iii) 如使用藥物後出現任可皮膚反應, 應立即停止治療, 並向醫生求診。

 

        The European Medicines Agency(EMA) notified healthcare professionals about her concluded announcement over the adverse risks of skin photosensitivity reactions associated with local uses of topical ketoprofen, an non-steroidal anti-inflammatory drug(NSAID) indicated to relief acute, localized, pain or inflammation due to minor traumas, tendonitis, small-joint osteoarthritis, phlebitis and at the lower-back. Accordingly, EMA described that the risk of serious photoallergic reaction was very low and that this risk could be minimized by harmonized risk-minimization measures. Despite of the benefit of using topical ketoprofen still outweigh the above risks, EMA recommended the following to physicians, pharmacists and other healthcare professionals:

  • be aware of the risk of photoallergy with topical ketoprofen;
  • tell their patients how to use topical ketoprofen appropriately;
  • ensure that their patients are aware of the following instruction:

i)   make sure that the treated areas are protected from sunlight during the whole period of ketoprofen treatment and the two weeks after stopping the treatment;

ii)  wash their hands carefully after each application of ketoprofen;

iii) discontinue treatment immediately if they develop any skin reaction after application of these medicines, and seek their doctor’s advice.

 

 

參考資料/Reference and website:

https://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Ketoprofen_topical/human_referral_000238.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac0580024e99&jsenabled=true


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