MHRA Issues Sabril Recall: Potential Risk to Children - 0 views
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pharmacybiz on 15 Jul 23The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 2 medicines recall for Sabril 500 mg film-coated tablets & Sabril 500 mg granules for oral solution. Sanofi UK has recalled the batches of Sabril tablets and Sabril granules as a precautionary measure due to the detection of traces of tiapride in the batches of the source material of the manufacturer for vigabatrin. Sabril (vigabatrin) is indicated for adjunctive treatment of focal seizures with or without secondary generalisation not satisfactorily controlled with other antiepileptics (under expert supervision) and monotherapy in the treatment of infantile spasms (West's syndrome). All patients are advised not to discontinue Sabril tablets or Sabril granules without consulting with their prescriber. The risks of suddenly stopping medication for seizures/epilepsy is higher than the potential risk presented by the presence of tiapride. Sanofi UK have confirmed to DHSC that no other batches are impacted, and other stock remains available.