Other safety alerts
|
| |
| European Union: European Medicines Agency starts review of orlistat-containing medicines |
| |
The European Medicines Agency has started a review of orlistat-containing anti-obesity medicines, to determine whether the very rare cases of hepatic injury have an impact on their benefit-risk profile and conditions of use. The review includes the centrally authorised prescription-only medicine Xenical (orlistat 120 mg) and the centrally authorised over-the-counter-medicine Alli (orlistat 60 mg), as well as a number of medicines containing orlistat that have either already or are in the process of being authorised at national level.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/09/news_detail_001345.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there are three registered products containing orlistat, namely Xenical, Zerocal and Alli. News about hepatic injury of Orlistat had been released by FDA and SFDA in May 2010 and March 2011 respectively. Press release and letter to inform the public and healthcare professionals were issued in May 2010. The issue was also discussed in the Registration Committee of Pharmacy and Poisons Board on 5 October 2010 and the Committee decided that the package insert of orlistat containing products have to include the warning of severe liver injury. Department of Health will keep vigilance aganist the result of EMA’s review.
Ends/ Friday, September 23, 2011
Issued at HKT 15:30
|
| |
|
