Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to the study by Oxford University on links between pregabalin and epilepsy, what recent assessment his Department has made of the safety of the epilepsy drug pregabalin.

The Medicines and Healthcare products Regulatory Agency (MHRA) continuously monitors the safety of all medicines on the market in the United Kingdom and seeks independent expert advice from the Commission on Human Medicines and its advisory groups on important new safety issues.

The MHRA is aware of the study by Molero et al published in the BMJ on 12 June 2019 which suggests that gabapentinoid medicines, pregabalin and gabapentin, are associated with an increased risk of suicidal behaviour, unintentional overdoses, head/body injuries and road traffic incidents and offences.

Pregabalin is authorised for the treatment of epilepsy, neuropathic pain and generalised anxiety disorder. Pregabalin is recognised to be associated with a range of possible side effects including dizziness, somnolence, loss of consciousness, confusion and mental impairment which could explain the increased risk of injuries and traffic accidents identified in this new study.

The product information for pregabalin currently contains relevant warnings regarding suicidal ideation and behaviour, possible side effects, as well as the possible effects on driving and operating machinery. The MHRA will carefully consider this new study and whether new advice needs to be issued to healthcare professionals and patients.