Public advisory - Sabril (vigabatrin) 500 mg sachets found to contain trace amounts of another drug

OTTAWA, ON, Aug. 18, 2023 /CNW/ -

• Product: Sabril (vigabatrin) 500 mg sachets, DIN 02068036, lots 3209710A and 3207333A
• Issue: Health products – Contamination
• What to do: Do not stop taking Sabril without consulting your health care professional as stopping this drug comes with serious risks. Unless you have a severe allergy to tiapride, the benefits of this drug are expected to continue to outweigh its potential risks despite the presence of trace amounts of tiapride. Monitor for any new and unexpected side effects. Seek immediate medical attention of you experience symptoms of a severe allergic reaction, such as difficulty breathing or swallowing or severe swelling of the lips, mouth or throat. Consult your health care professional if you have any concerns.

Affected products

Lundbeck Canada Inc. has informed Health Canada that two lots of Sabril (vigabatrin) 500 mg powder for oral solution, in sachet format, were found to contain trace amounts of another prescription drug, tiapride.

Sabril is a prescription drug used to manage epileptic seizures in adults and children, and for infantile spasms (West Syndrome). 

Health Canada has determined that the health risk of the trace contamination to patients is low. It is important that patients do not stop taking their Sabril as prescribed without consulting their physician, as the benefits of this drug are expected to outweigh its potential risks despite trace amounts of tiapride, unless patients have a severe allergy to tiapride. Sabril therapy should not be interrupted, as this may increase the risk of seizures, which could be life-threatening.

There are no authorized products containing tiapride in Canada. In some other countries, tiapride is a drug used to treat a range of neurological and psychiatric disorders including dyskinesia (involuntary movements), alcohol withdrawal syndrome, psychosis, agitation and aggression in the elderly, and tic disorders in children.

Lundbeck Canada Inc., the Canadian manufacturer of Sabril, is reporting ongoing shortages of this medication and no alternative supply is available in Canada at this time. As a result, Health Canada is not recommending that the company recall this medication at this time. Health Canada continues to monitor the situation.

Health Canada recognizes how important Sabril is for the people taking it. Health Canada is leading work with provincial and territorial governments, manufacturers and stakeholders across the supply chain and healthcare system to mitigate the ongoing shortage of Sabril. This includes accessing additional foreign-authorized supply, where possible.

Although this drug is not being recalled, Health Canada is monitoring the company's implementation of any necessary corrective and preventative actions to prevent this from happening again.

• Do not stop taking your Sabril medication without consulting your physician.
• Monitor for any new and unexpected side effects. Seek immediate medical attention of you experience symptoms of a severe allergic reaction, such as difficulty breathing or swallowing or severe swelling of the lips, mouth or throat.
• Consult your health care professional if you or your child are taking Sabril and you have any concerns.
• Report any health product-related side effects or complaints to Health Canada.

Également disponible en français

SOURCE Health Canada