Recall of two Valproic acid drugs, Depakene 500 mg and Ratio-Valproic 500 mg

Warning
2007-55
May 11, 2007
For immediate release

OTTAWA - Health Canada is warning patients taking the anti-epilepsy medications Depakene 500 mg and ratio-VALPROIC 500 mg that they may not be getting the full dose of the active drug, which could result in inadequate treatment of their seizures. These products are being recalled and patients using Depakene 500 mg and ratio-VALPROIC ECC 500 mg (valproic acid) are advised to contact their physician or pharmacist immediately to obtain another suitable product. Patients should not discontinue their medication before consulting their health care provider.

If seizures are not adequately treated, patients are at risk of increasing number and frequency of seizures and of related complications, including injury from falls, injury from a seizure while driving or operating machinery, or inhalation of fluid into the lungs and aspiration pneumonia.

ABBOTT Laboratories Limited is recalling Depakene 500 mg and ratiopharm Inc. is recalling ratio-VALPROIC 500 mg. The capsules may not disintegrate properly; as a result, a lesser amount of the active ingredient may be released. Consumers who have purchased either of these products should return their product to their pharmacist.

Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

To report a suspected adverse reaction to this or any other health product, please contact the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada by one of the following methods:

Telephone: 1-866-234-2345
Facsimile: 1-866-678-6789

CADRMP
Marketed Health Products Directorate
Tunney's Pasture, AL 0701C
Email: cadrmp@hc-sc.gc.ca

The CADRMP adverse reaction reporting form, including a version that can be completed and submitted online, is located on the MedEffect portal of the Health Canada Web site (www.medeffect.gc.ca).

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Media Enquiries:
Alastair Sinclair
Health Canada
(613) 957-1803

Public Enquiries:
(613) 957-2991
1-866 225-0709