Other safety alerts
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| Canada: Valproate anti-epileptic drugs may pose risks to children when taken by mothers during pregnancy |
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Health Canada is reminding Canadians, particularly women of child-bearing age, of the risks to children whose mothers take a valproate drug, used to treat epilepsy, while pregnant. The risk of birth defects in children whose mothers took a valproate drug while pregnant is a rare but well known risk associated with their use. Recent studies have also found that children whose mothers took a valproate drug tend to score lower on cognitive (intelligence) tests than children whose mothers who took other anti-epileptic medications during pregnancy. Patients are reminded not to stop taking or switch their medication without first speaking to a healthcare practitioner, as stopping a valproate drug suddenly can cause serious problems. Not treating epilepsy during pregnancy can be harmful to women and their developing babies. Health Canada continues to monitor the safety of valproate drugs and will continue to update Canadians with new safety recommendations regarding valproate products as they emerge.
Please refer to the following website in Health Canada for details:
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_90-eng.php
Situation in Hong Kong: The news has been released by the US FDA and posted on the website of Pharmaceutical Service on 2 July 2011. There are 16 products containing valproate sodium, divalproex sodium and valproic acid in Hong Kong. These are all prescription medicines. A letter to inform healthcare professionals regarding this safety news has been issued on 4 July 2011. Department of Health will keep vigilance against any new safety information related to the drug and the above matter will be discussed in the coming meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/Saturday, July 9, 2011
Issued at HKT 12:00
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