Parents and carers advised to inspect Buccolam oral syringes before use

January 19, 2018

This news story is based on an alert issued by the Medicines and Healthcare products Regulatory Agency (MHRA), asking all healthcare professionals to speak to parents and carers about carefully inspecting Buccolam pre-filled plastic syringes before giving the medicine to their child.

Buccolam is an epilepsy medicine, which is available as pre-filled oral syringes. A defect with some syringes has been reported. In a small number of cases, the translucent (white) tip-cap can sometimes remain attached to the syringe after the red cap has been taken off – this is a choking hazard.

Buccolam remains safe to use if the instructions are followed. Carefully check the syringe before giving the medicine and remove the translucent tip-cap manually if it is still on the syringe after the red cap has been pulled off. Please see the diagram below illustrating this.

If you think the tip-cap is in your child’s mouth, do not attempt to remove it. Instead, turn your child onto their side (recovery position) and make sure they spit it out when they stop fitting.

The manufacturer is working to resolve this issue for new syringes.

If patients, parents, or carers have any questions or want to report any side effects, they should talk to a doctor, pharmacist, or nurse. They should also tell them about any occasions in which the translucent tip-cap remained attached to the syringe.

Suspected side effects can also be reported directly to MHRA via the Yellow Card Scheme https://yellowcard.mhra.gov.uk/

For further information, please see further links included within the original MHRA news story: www.gov.uk/government/news/parents-and-carers-advised-to-inspect-buccolam-oral-syringes-before-use