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<p>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.</p><p>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.</p><p>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.</p><p>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.</p><p><strong> </strong></p>
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