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Gabapentin and risk of severe respiratory depression

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In a recent Drug Safety Update, the Medicines and Healthcare products Regulatory Agency (MHRA) warned about a rare risk of severe respiratory depression with gabapentin, with or without concomitant use of opioids.1 In England, 6.5 million prescriptions for gabapentin were dispensed in 2016.2

A European review of gabapentin was triggered by reports of patients developing respiratory depression without concomitant use of opioids — this reaction had already been recognised with concomitant use of gabapentin with opioids.3 Based on the available evidence, the review recommended that the product information for gabapentin be amended to include warnings for severe respiratory depression, which may affect up to 1 in 1,000 patients.

Healthcare professionals are advised to:1

  • be aware of the risk of CNS depression, including severe respiratory depression, with gabapentin;

  • consider whether dose adjustments might be necessary in patients at higher risk of respiratory depression, including older people, patients with compromised respiratory function, respiratory or neurological disease or renal impairment and patients taking other CNS depressants; and

  • report any suspected adverse reactions on a Yellow Card.

The product information for gabapentin is being updated to include warnings about breathing problems.4 The patient information leaflet notes that gabapentin can cause “breathing problems, which if severe you may need emergency and intensive care to continue breathing normally”.5 The leaflet advises patients to seek medical help if they have any trouble breathing or are taking shallow breaths.

Clinicians are also reminded of the increased risk when prescribing gabapentin in patients who require concomitant treatment with opioids. Patients should be carefully observed for signs of CNS depression, such as somnolence, sedation and respiratory depression, and the dose of either gabapentin or the opioid should be reduced appropriately.

Comment: Healthcare professionals should ensure that they are familiar with the updated safety warnings for gabapentin.


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