ADR that result in revision of patient information
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| The United States: Valproate Anti-Seizure Products: Drug Safety Communication - Contraindicated for Pregnant Women for Prevention of Migraine Headaches |
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The Food and Drug Administration (FDA) is advising healthcare professionals and women that the anti-seizure medication valproate sodium and related products, valproic acid and divalproex sodium, are contraindicated and should not be taken by pregnant women for the prevention of migraine headaches. Based on information from a recent study, there is evidence that these medications can cause decreased IQ scores in children whose mothers took them while pregnant. Stronger warnings about use during pregnancy will be added to the drug labels, and valproate’s pregnancy category for migraine use will be changed from "D" (the potential benefit of the drug in pregnant women may be acceptable despite its potential risks) to "X" (the risk of use in pregnant women clearly outweighs any possible benefit of the drug).
With regard to valproate use in pregnant women with epilepsy or bipolar disorder, valproate products should only be prescribed if other medications are not effective in treating the condition or are otherwise unacceptable. Valproate products will remain in pregnancy category D for treating epilepsy and manic episodes associated with bipolar disorder.
With regard to women of childbearing age who are not pregnant, valproate should not be taken for any condition unless the drug is essential to the management of the woman's medical condition. All non-pregnant women of childbearing age taking valproate products should use effective birth control.
This safety communication is based on the final results of the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study showing that children exposed to valproate products while their mothers were pregnant had decreased IQs at age 6 compared to children exposed to other anti-epileptic drugs. The difference in average IQ between the children who had been exposed to valproate and the children who had been exposed to other antiepileptic drugs varied between 8 and 11 points depending on the drug to which valproate was compared.
FDA previously communicated initial findings about this risk in a June 2011 Drug Safety Communication and revised the drug labels after interim results from the NEAD study showed lower cognitive test scores at age 3 in children exposed to valproate compared to children exposed to other antiepileptic drugs.
Women who are pregnant and taking a valproate medication should not stop their medication but should talk to their healthcare professionals immediately. Stopping valproate treatment suddenly can cause serious and life-threatening medical problems to the woman or her baby. FDA is working with manufacturers to change the drug labels for valproate products with this updated risk information.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm350868.htm
In Hong Kong, there are 13 registered pharmaceutical products containing valproate and valproic acid and they are prescription-only medicines. There is no registered pharmaceutical product containing divalproex. News regarding the increased risk of impaired cognitive development in children exposed during pregnancy with valproate or related products had been released by FDA and Health Canada, and was posted on the website of Drug Office on 2 July 2011 and 9 July 2011 respectively. Letter to inform healthcare professionals to draw their attention on 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. So far, the Department of Health has not received any related adverse reports in connection with the drugs. In view of FDA’s latest recommendation, a letter to inform healthcare professionals will be issued and the matter will be discussed in the Committee.
Ends/ Tuesday, May 07, 2013
Issued at HKT 14:00
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