有 關 個 別 藥 物 或 某 類 別 藥 物 的 安 全 資 訊
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| European Union: Use of metformin to treat diabetes now expanded to patients with moderately reduced kidney function (English Only) |
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The European Medicines Agency (EMA) has concluded that metformin-containing medicines can now be used in patients with moderately reduced kidney function (GFR [glomerular filtration rate]=30–59 ml/min) for the treatment of type 2 diabetes. The product information for these medicines will be updated to revise the current contraindication and give information about doses, monitoring and precautions in patients with reduced kidney function.
The recommendations are the result of a review by EMA of metformin-containing medicines following concerns that current scientific evidence does not justify a contraindication in patients with moderate reduction of kidney function.
Companies marketing metformin-containing medicines will be requested to closely monitor and analyse future lactic acidosis cases and report these during upcoming periodic safety reviews in order to follow up on any changes in the frequency of this side effect.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_002620.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there are 124 registered pharmaceutical products containing metformin, which are prescription only medicines. Related news was previously released by EMA and FDA, and was posted on the website of Drug Office on 1 February 2016 and 9 April 2016, respectively. Letters to inform local healthcare professionals were issued on 11 April 2016. So far, the Department of Health (DH) has received eight adverse drug reaction cases related to metformin, and two of them involved lactic acidosis after taking the drug. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board. DH will remain vigilant on the safety updates from other overseas drug regulatory authorities.
Ends/ Saturday, October 15, 2016
Issued at HKT 12:00
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