Comtan, Stalevo (entacapone): Drug Safety Communication - Ongoing Safety Review of Stalevo (entacapone/carbidopa/levodopa) and Possible Development of Prostate Cancer
AUDIENCE: Pharmacy, Neurology, Urology, Patient
ISSUE: FDA review finds no increased risk of prostate cancer with Parkinson's disease medicines, Comtan (entacapone) and Stalevo (a combination of entacapone, carbidopa, and levodopa).
BACKGROUND:
FDA alerted the public of a clinical trial in March 2010 suggesting a possible increased risk of prostate cancer with the entacapone component of Stalevo. FDA subsequently required the Stalevo manufacturer, Novartis, to conduct a study to further evaluate this potential risk. FDA also studied this issue independently using data from the Department of Veterans Affairs Health Care System. Based on these additional studies, FDA concluded that entacapone use is not associated with an increased risk of prostate cancer ( see Data Summary).
RECOMMENDATION:
As a result, FDA' s recommendations for using Comtan (entacapone) and Stalevo (a combination of entacapone, carbidopa, and levodopa) will remain the same in the prescribing information.
Health care professionals should follow standard prostate cancer screening recommendations for patients.
Patients should continue to take their medicine as prescribed. Talk to your health care professionals if you have any questions or concerns.
Read the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at:
https://www.fda.gov/drugs/drug-safety-and-availability/fda-review-finds-no-increased-risk-prostate-cancer-parkinsons-disease-medicines-containing?utm_campaign=FDA%20MedWatch%20-%20Comtan%2C%20Stalevo%20%28entacapone%29%3A%20Drug%20Safety%20Communication&utm_medium=email&utm_source=Eloqua
美國FDA審查發現使用帕金森氏藥物Comtan (entacapone)和Stalevo (entacapone, carbidopa, and levodopa) 的病人其前列腺癌的風險並未增加。美國FDA曾於2010年3月根據一臨床試驗發布藥物安全警訊：使用Stalevo其中之一成份entacapone可能增加罹患前列腺癌的風險。美國FDA隨後要求Stalevo製造商Novartis進行相關研究，以進一步評估此潛在風險。美國FDA亦另外使用退伍軍人醫療保健系統的資料庫研究此問題。根據這些額外的研究，美國FDA表示entacapone的使用與前列腺癌風險的增加無關。
因此，美國FDA對於Comtan (entacapone)和Stalevo (entacapone, carbidopa, and levodopa)仿單中的使用建議維持不變。醫療專業人員治療病人仍應遵循標準前列腺癌篩檢建議。病人應繼續依照指示服藥。若有任何問題或疑慮，請諮詢醫療專業人員。
相關訊息與連結請參考FDA網址：
https://www.fda.gov/drugs/drug-safety-and-availability/fda-review-finds-no-increased-risk-prostate-cancer-parkinsons-disease-medicines-containing?utm_campaign=FDA%20MedWatch%20-%20Comtan%2C%20Stalevo%20%28entacapone%29%3A%20Drug%20Safety%20Communication&utm_medium=email&utm_source=Eloqua
[Posted 08/13/2019]
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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