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Pregabalin has been associated with infrequent reports of severe respiratory depression, including some cases without the presence of concomitant opioid medicines. Patients with compromised respiratory function, respiratory or neurological disease, renal impairment; those using concomitant central nervous system (CNS) depressants; and people older than 65 years might be at higher risk of experiencing these events and adjustments in dose or dosing regimen may be necessary.
Pregabalin is indicated in adults for the treatment of peripheral and central neuropathic pain, as adjunctive therapy in adults with partial seizures with or without secondary generalisation, and for generalised anxiety disorder in adults.
Use of pregabalin with opioid medicines or other central nervous system (CNS) depressant medicines has been previously associated with reports of respiratory failure, coma, and deaths. Studies show use of high doses of pregabalin (over 300mg a day) alongside opioid medicines to be particularly associated with an increased risk of opioid-related death[footnote 1].
A recent European review of safety data considered reports of severe respiratory depression thought to be related to the action of pregabalin alone on the CNS. Given the available data on this risk, including spontaneous reports, and the plausible mechanism of action, the product information for medicines available in the UK will be amended to include new warnings for respiratory depression.
The review identified a small number of worldwide cases of respiratory depression without an alternative cause or underlying medical conditions. In these cases, respiratory depression had a temporal relationship with the initiation of pregabalin or dose increase. Other cases were noted in patients with risk factors or underlying medical history. The majority of cases reviewed were reported in elderly patients.
Similar warnings are already in place for gabapentin (Neurotonin), the other gabapentinoid medicine available in the UK – see Drug Safety Update, October 2017.
Adjustments in dose or dosing regimen might be necessary in patients at increased risk of experiencing this severe adverse reaction, including patients:
The patient information leaflet that accompanies pregabalin is being updated to include warnings about breathing problems. The leaflet advises patients to seek medical help if they experience any trouble breathing or are taking shallow breaths related to their medicine.
Pregabalin clearance is directly proportional to creatinine clearance, and dose reductions in patients with compromised renal function should be individualised – see the posology section of the Summary of Product Characteristics.
In the UK, from January 2014 to 31 December 2020, we have received 122 reports of respiratory depression or dyspnoea associated with pregabalin to the Yellow Card scheme. 80 of 122 cases report a CNS depressant as either a co-suspect or concomitant medicine alongside pregabalin. Co-administered CNS depressant medicines include opioids, benzodiazepines, and gabapentin.
As of 1 April 2019, pregabalin and gabapentin are controlled under the Misuse of Drugs Act 1971 as Class C substances and scheduled under the Misuse of Drugs Regulations 2001 as Schedule 3 – see Drug Safety Update, April 2019.
Existing advice asks healthcare professionals to evaluate patients carefully for a history of drug abuse before prescribing pregabalin and gabapentin and to observe patients for development of signs of abuse and dependence.
As for all medicines, patients should be given information on the expected benefits and potential risks of pregabalin and gabapentin, including through provision of the Patient Information Leaflet at dispensing. Prescribers should be aware of all medicines (including any over-the-counter products or illicit drugs) patients are taking to minimise or avoid drug interactions.
Please continue to report suspected adverse drug reactions to the Yellow Card scheme. Healthcare professionals, patients, and caregivers are asked to submit reports using the Yellow Card scheme electronically using:
If a patient experiences any side effect related to dependence to a medicine or is recognised by the prescriber to be dependent, we encourage prescribers, patients, or carers to report this to the MHRA with the term ‘dependence’. Use of this specific term will assist the MHRA to monitor the rates reported in the UK and therefore to further protect public health.
When reporting please provide as much information as possible, including information about batch numbers, medical history, any concomitant medication, onset timing, treatment dates, and product brand name.
Report suspected side effects to medicines, vaccines or medical device and diagnostic adverse incidents used in coronavirus (COVID-19) using the dedicated Coronavirus Yellow Card reporting site or the Yellow Card app. See the MHRA website for the latest information on medicines and vaccines for COVID-19.
Article citation: Drug Safety Update volume 14, issue 7: February 2021: 2.
Gomes T and others. Pregabalin and the risk for opioid-related death: a nested case-control study. Ann Intern Med. 2018; issue 169: 732–34. ↩
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Pregabalin (Lyrica): reports of severe respiratory depression – GOV.UK
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