The Health and Social Care Board (HSCB) of Northern Ireland has written to GPs notifying them of the removal of pregabalin from the neuropathic pain formulary and advising them that the drug should no longer be initiated for this indication.
Figures gathered by the Northern Ireland Statistics and Research Agency show deaths associated with pregabalin use increasing from 1 death in 2013 to 54 and 77 in 2018 and 2019, respectively. In total, 186 pregabalin-associated deaths have been reported, equating to 13 per cent of all drug-related deaths in the country between 2009 and 2019. By comparison, gabapentin, another gabapentinoid, was associated with 28 deaths over the same 10-year period.
The HSCB recommends that patients already prescribed pregabalin for neuropathic pain should be reviewed and the drug withdrawn gradually as appropriate. Suggested suitable replacement therapies include amitriptyline (first line) and gabapentin (second line).
Pregabalin has fallen under the spotlight several times in recent years with the drug being reclassified as a Class C controlled substance in April 2019 because of the evidence for risk of abuse and dependence. Also in 2019, the authors of a meta-analysis published in the BMJ stated that prescribers should be aware of pregabalin's 'numerous side-effects' when considering the drug as a treatment option for neuropathic pain.
Similarly, NICE guidance for the management of low back pain and sciatica, updated in 2020, recommends that gabapentinoids (pregabalin and gabapentin) should not be offered for management of neuropathic pain associated with sciatica as there is no overall evidence of benefit and there is evidence of harm.
Earlier this year pregabalin was also linked to severe respiratory depression in the absence of opioids, with the MHRA subsequently advising prescribers to consider adjusting dosing of the drug in patients at higher risk of respiratory depression.