MHRA recalls Sabril 500mg film-coated tablets and 500mg granules for oral solution

The 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.

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.

Although Sanofi UK has confirmed the presence of tiapride by carrying out analytical testing of impacted batches, the trace amounts of tiapride observed in the source material are significantly lower than permitted daily exposure to tiapride in adults. 

However, there is a potential risk to children who may have or are taking the impacted batches of Sabril tablets or Sabril granules. This is a theoretical risk as the calculation is based on the amount of tiapride detected in the source material. A precautionary recall is undertaken in view of the potential for serious adverse events in children.

Sabril 500 mg film-coated tablets Pl 04425/0171

Active Pharmaceutical Ingredient: Vigabatrin

Sabril 500 mg granules for oral solution, PL 04425/0170

Active Pharmaceutical Ingredient: Vigabatrin

Healthcare professionals are advised to Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

Based on the distribution dates most of the stock of these batches will have been used already, however healthcare professionals should note the specific advice for adults and children, who may have been or are taking the impacted batches of Sabril tablets or Sabril granules in the sections below. The information for children who have been prescribed/dispensed Sabril tablets or granules includes a direct action to contact patients/parents/carers/guardians and consider recall, where appropriate.

DHSC has urged pharmacists involved in dispensing this product should immediately contact all patients who have been dispensed the impacted batches and ask them to confirm if they have remaining stock of the impacted batches within their possession.

“If batch traceability information is not available, all patients dispensed Sabril 500 mg granules for oral solution since September 2021 and/or Sabril 500 mg film-coated tablets since July 2022 should be contacted. This information is based on the first distribution dates as indicated in the product details within this notification.

If the pharmacist identifies any child patients with an impacted batch, they should, in the first instance, contact the patient/parents/carers/guardians and inform them of the information in this recall. They should be advised to seek a review from their GP, specialist prescriber or other relevant prescriber responsible for their care. If the patient has an impacted batch then an alternative batch should be provided and the impacted batch recalled. Patients may need to obtain additional prescriptions for further supply, however this should not cause any interruptions to treatment.”