The early warning and emerging trends (EWET) group chaired by the Department of Health is considering a consultation process on controlling pregabalin and gabapentin, which are indicated for the treatment of epilepsy, peripheral and neuropathic pain and generalised anxiety disorder in adults. The EWET is part of the national advisory committee on drugs and alcohol.
A Department spokesperson told the Medical Independent: “The controlling of substances under the Misuse of Drugs Acts 1977-2016 requires a clear evidence base and an analysis of the benefits and risks. If evidence exists to suggest that the scheduling of a substance would reduce its misuse or abuse, a multiple stakeholder approach is required, to include a referral to the European Commission.
“The Department is aware of control measures recently implemented in the UK and Northern Ireland and the data in respect of these measures is still under review by the respective authorities. The early warning and emerging trends group chaired by the Department of Health is considering a consultation process.” In January 2020, National Clinical Lead of the Medicines Management Programme Prof Michael Barry wrote to GPs to “highlight the high level of prescribing of pregabalin and importantly, the risks associated with its use”, including risk of addiction.
Prof Barry’s correspondence included a summary guidance document on appropriate prescribing of pregabalin. He also advised that a prescribing analysis report of pregabalin for patients in their practice would issue in the coming months. In its September 2021 newsletter, the Health Products Regulatory Authority (HPRA) highlighted “that pregabalin has been associated with reports of respiratory depression in the absence of concomitant therapy with opioids or other central nervous system (CNS) depressants, in patients with and without other risk factors for respiratory depression”, as per findings from the pharmacovigilance risk assessment committee of the European Medicines Agency.
The HPRA advised that the product information would be updated and include respiratory depression as an adverse reaction with a frequency of ‘not known’. It was already known that concomitant use of pregabalin with opioids and/or other CNS depressants was associated with reports of respiratory failure, coma and deaths, and this risk was reflected in the product information.