Other safety alerts
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| European Union: Review of metformin-containing medicines started |
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The European Medicines Agency (EMA) has started a review of all metformin-containing medicines. Metformin, alone or in combination with other medicines, is widely used for treating type 2 diabetes.
This review was requested by the Dutch medicines agency (the Medicines Evaluation Board, MEB) following a routine evaluation of the safety of metformin medicines. This evaluation showed that the prescribing information for metformin-containing medicines varies between countries and products in its advice on how the medicine should be used in patients with reduced kidney function.
Metformin may cause a rare but serious complication called lactic acidosis, which is when lactic acid, a natural by-product of the body, builds up in the blood faster than it can be removed. Patients on metformin who have significant reduction in kidney function are at a higher risk of developing lactic acidosis because their kidneys are unable to remove enough lactic acid. Thus, currently the prescribing information states that metformin must not be used in these patients.
The Dutch review found that the current scientific evidence might not justify contraindicating metformin in patients with moderate reduction of kidney function. This large group of patients may stand to benefit from treatment with metformin. In addition, the recommendations in the prescribing information are often inconsistent with clinical guidelines on the treatment of diabetes. Thus, the MEB considered that the prescribing information for all metformin-containing medicines should be reviewed to harmonise the recommendations on their use in patients with significant kidney problems.
EMA will now review the data on the different metformin medicines and consider how the prescribing information for these medicines should be updated, and it will issue an opinion on the marketing authorisations of these medicines across the EU.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../human_referral_000397.jsp&mid=WC0b01ac05805c516f
In Hong Kong, there are 120 registered pharmaceutical products containing metformin, which are prescription only medicines. So far, the Department of Health has received seven adverse drug reaction cases related to metformin, and two of them involved lactic acidosis after taking the drug. In view of the Martindale has stated biguanides (including metformin) are generally avoided in patients with renal impairment because of the risk of lactic acidosis, and the EMA has just started the review of metformin-containing medicines which is not yet concluded, DH will remain vigilant on the conclusion of the review and safety updates from other overseas drug regulatory authorities.
Ends/ Monday, February 01, 2016
Issued at HKT 16:00
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