Epilepsy drug recalled over contamination fears

Pharmacies have been ordered to return batches of a drug used to treat convulsive seizures in epilepsy sufferers due to concerns it could be contaminated with another potentially dangerous medication.

The call was made by Ireland’s drugs watchdog the Health Products Regulatory Authority, previously the Irish Medicines Board, after the issue was highlighted during a routine inspection of where the item was manufactured.

The drug in question, made by Viro Pharm a SPRL, is called Buccolam Oromucosal Solution and is regularly provided to pharmacies across the country.

The prescription-only medication is administered in the side of the mouth through pre-filled syringes to children and teenagers up to the age of 18.

A HPRA spokesperson said that after an examination of where the drug is made in Britain by the UK’s drugs watchdog, a “theoretical risk of cross-contamination” was identified.

While the HPRA said the possibility of the cross-contamination taking place was “very low”, she stressed that as “a precaution” several “specific” batches of the medication have been recalled from pharmacies nationwide.

“As a precautionary measure, the company Viro Pharma SPRL is recalling from pharmacies several specific batches of the Buccolam Oromucosal Solution products used to treat convulsive seizures in children and adolescents.

“An issue has been identified in relation to manufacturing controls in place at the manufacturing site. As a consequence, there was a theoretical risk of cross-contamination.

“This risk has been assessed as being very low. There is no evidence of any actual cross-contamination having occurred with the Buccolam products, and the potential contaminant has not been detected in any batch of Buccolam during product testing to date.

“Nevertheless, these batches of Buccolam are being recalled to pharmacy level as a precautionary measure,” the HPRA spokesperson said.

The specific drug batches being recalled are Buccolam 2.5mg Oromucosal Solution; Buccolam 5mg Oromucosal Solution; Buccolam 7.5mg Oromucosal Solution; and Buccolam 10mg Oromucosal Solution.

More than 37,000 Irish people are known to have epilepsy.

© Irish Examiner Ltd. All rights reserved

Email Updates

Receive our lunchtime briefing straight to your inbox

More in this Section

Group reveals €2m investment for Cork hotel

New website aims to get college students involved in volunteer activities

Fisheries and cannibalism linked to seal deaths

Fine Gael labelled ‘the landlord party’ due to homeless crisis


Breaking Stories

Martin McGuinness 'pulled out of China visit on medical advice'

Outbreak of winter vomiting bug at University Hospital Limerick

GPs report increase in waiting times for patients

Terry Wogan honoured at Áras an Uachtaráin

Lifestyle

Watch Michelle Darmody make the perfect Christmas cocktail

Dowcha Puppets pulling the strings for panto in Cork

Five 'Very Important Patients' at Temple Street pick the best toys of 2016

Full disclosure in Oliver Stone's new film about CIA whistleblower Edward Snowden

More From The Irish Examiner