Reference

Drug alert 25/2023

Name

Drug alert class 2 – 25 2023 – Class 2 medicines recall – action within 48 hours - Aventis Pharma Ltd (t/a Sanofi UK) Sabril 500mg film-coated tablets

Categories

Scottish Government Drug Alerts

Organization

Scottish Government Health and Social Care Directorates

Keywords

NHS SCOTLAND DRUGS SAFETY RISKS PHARMACEUTICAL INDUSTRY MEDICINES RECALL

Description

Sanofi UK is recalling the listed 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 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 should be 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 that no other batches are impacted, and other stock remains available. There are no licenced products that contain tiapride in the UK and to date, tiapride use has not been thoroughly investigated in children. Tiapride is indicated for the treatment of a variety of neurological and psychiatric disorders including dyskinesia, alcohol withdrawal syndrome, negative symptoms of psychosis, and agitation and aggression in the elderly.

Contact Name

Irene Fazakerley

Contact Email

Contact Address

Contact Phone

Created

2023-07-13 00:00:00

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