Other safety alerts
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| European Union: Update on the ongoing review of valproate and related substances |
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To inform its ongoing review of valproate and related substances, the PRAC discussed feedback received during a meeting organised with valproate patients, carers and their families. Valproate medicines are used for treating epilepsy and bipolar disorder and in some countries, migraine. The PRAC initiated a review of these medicines in October 2013 following the publication of new studies which showed a possible risk of long-term problems in development in children born to women treated with valproate. As part of this review, the PRAC sought to actively involve representatives from patients’ organisations concerned with epilepsy, bipolar disorder and migraine and also organisations representing the patients, families and carers who have been affected by valproate. Consequently, a meeting was organised at the end of June involving various patients' organisations, and representatives from PRAC as well as EMA staff. This valuable input from patients, carers and their families will be taken forward by the PRAC in reaching its recommendation on valproate and related substances.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_002136.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there are 10 registered pharmaceutical products containing valproate/ valproic acid. All of them are prescription-only medicines. News regarding the increased risk of impaired cognitive development in children born to pregnant women treated with valproate or related products has been released by the US FDA and Health Canada, and was posted on the website of Drug Office on 2 July 2011 and 9 July 2011 respectively. So far, the Department of Health (DH) has not received any local adverse drug reaction report related to the drug. Letter to healthcare professionals to draw their attention to the issue and urge them to report any adverse drug reaction related to the drug was issued on 4 July 2011. The matter was discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board (the Committee) in September 2011. The Committee decided that the package insert of valproate or related products should be updated to include the appropriate safety information. The DH will remain vigilant on any safety updates related to the drugs and actions taken by overseas regulatory authorities.
Ends/ Monday, July 14, 2014
Issued at HKT 14:00
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