其 他 安 全 警 示
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| The United States: FDA review finds no increased risk of prostate cancer with Parkinson's disease medicines containing entacapone (Comtan, Stalevo) (English only) |
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The US Food and Drug Administration (FDA) announces that its review of additional data found no increased risk of prostate cancer with the use of entacapone to treat Parkinson’s disease. FDA conducted this review after an earlier trial suggested this possible risk. As a result, its recommendations for using Comtan (entacapone) and Stalevo (a combination of entacapone, carbidopa, and levodopa) will remain the same in the prescribing information.
FDA alerted the public in Mar 2010 that FDA was aware of a clinical trial 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.
Health care professionals should follow standard prostate cancer screening recommendations for patients. Patient and caregivers should continue to take their medicine as prescribed and talk to their health care professionals if they have any questions or concerns.
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/drug-safety-and-availability/fda-review-finds-no-increased-risk-prostate-cancer-parkinsons-disease-medicines-containing
In Hong Kong, there are 12 registered pharmaceutical products containing entacapone, and all products are prescription-only medicines. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to entacapone. Related news was previously issued by FDA, and was posted on the Drug Office website on 1 Apr 2010. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Wednesday, Aug 14, 2019
Issued at HKT 16:00
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