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.
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