Other safety alerts
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| Canada: Sabril (vigabatrin) 500 mg sachets and tablets found to contain trace amounts of another drug: Update |
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Health Canada announces that Lundbeck Canada Inc. is releasing one lot of Sabril (vigabatrin) 500 mg tablets (lot number: 3216947) on the Canadian market found to contain trace amounts of another prescription drug, tiapride. The tablets are being released given the current shortage and no immediate available alternative supply of tablets.
Unless patients 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. Patients are advised to not stop taking Sabril without consulting their health care professional, as stopping this drug comes with serious risks.
The above-mentioned release of one lot of Sabril (vigabatrin) 500 mg tablets on the Canadian market will help meet demand for the product until additional supply is available.
Please refer to the following website in Health Canada for details:
http://recalls-rappels.canada.ca/en/alert-recall/sabril-vigabatrin-500-mg-sachets-and-tablets-found-contain-trace-amounts-another-drug
In Hong Kong, Sabril Tab 500mg (HK-35365) is a pharmaceutical product registered by Sanofi Hong Kong Limited (Sanofi). The product is a prescription-only medicine. As confirmed with Sanofi, the affected lot in Canada (lot number: 3216947) has not been imported into Hong Kong.
On 13 Jul 2023, the Department of Health (DH) endorsed Sanofi to recall one batch (batch number: 2991A) of Sabril Tab 500mg (HK-35365) from the market due to potential quality issue. The DH received notification from Sanofi that the overseas manufacturer of the product reported that trace amount of an impurity identified as tiapride was detected in the product. The most probable cause was due to carryover of tiapride on the same equipment during production of active ingredient vigabatrin. The level of tiapride detected was below the permitted daily exposure. As a precautionary measure, Sanofi is voluntarily recalling the affected product from the market. A recall statement was posted on the Drug Office website on the same date.
Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 14 Jul 2023, with the latest update posted on 28 Jul 2023.
Ends/Friday, Nov 10, 2023
Issued at HKT 14:00
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