其 他 安 全 警 示
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| European Union: European Medicines Agency clarifies opinion on pioglitazone and the risk of bladder cancer (English Only) |
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The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has clarified its opinion on pioglitazone-containing anti-diabetes medicines and the risk of bladder cancer following its failure to gain endorsement from Standing Committee on Medicinal Products for Human use for legal enforcement of its opinion.
The CHMP confirmed its previous opinion in July 2011 on that there was a small increase risk of bladder cancer associated with the use of pioglitazone and that pioglitazone should remain available as a treatment option, but that prescribers should carefully select patients and monitor their response to treatment. With these clarifications, the CHMP is reminding doctors that pioglitazone remains a valid treatment option for certain patients with type 2 diabetes, when certain other treatments (metformin) have not been suitable or have failed to work adequately.
The updated opinion has now been sent to the European Commission and is expected to be endorsed by the Standing Committee within the next two to three months.
Please refer to the following website in EMA for details:http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/10/news_detail_001368.jsp&mid=WC0b01ac058004d5c1
Situation in Hong Kong: In Hong Kong, there are 24 pioglitazone-containing products (including Actos) registered and are prescription-only medicines. The safety news related to the risk of bladder cancer has been released by the EMA, the US FDA, Health Canada, Australia TGA and Singapore HSA and was posted on the website of Drug Office in June, July and August 2011. A letter to healthcare professionals was issued on 16 June 2011 and 22 July 2011. The issue was also discussed in the Registration Committee of Pharmacy and Poisons Board on 6 September 2011 and the Committee decided that the package insert and/or sales pack of pioglitazone should include the safety warnings related to the risk of bladder cancer. Department of Health will keep vigilance against any new safety information in relation to the drug.
Ends/Saturday, October 22, 2011
Issued at HKT 12:00
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