Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps are being taken to inform patients and healthcare professionals about the potential long-term risks of Gabapentin use.

Gabapentin is authorised to treat epilepsy and peripheral neuropathic pain, or nerve pain. The known side effects of gabapentin are outlined in the product information, the Summary of Product Characteristics (SPC) for healthcare professionals, and the Patient Information Leaflet which is provided in each pack of the medicine.

The SPC states that in the treatment of peripheral neuropathic pain, such as painful diabetic neuropathy and post-herpetic neuralgia, efficacy and safety have not been examined in clinical studies for treatment periods longer than five months. If a patient requires the medication for longer than five months to treat peripheral neuropathic pain, the treating physician should assess the patient's clinical status and determine the need for additional therapy. Epilepsy normally requires long-term treatment and the SPC states that the dosage for gabapentin should be determined by the treating physician according to the clinical response and side effects experienced by the individual patient.

The product information for gabapentin lists amnesia as a common side effect and mental impairment as an uncommon side effect. Dementia is not a known side effect of gabapentin.

Gabapentin can cause drug dependence, and the product information includes warnings that patients treated with gabapentin should be monitored for symptoms of misuse, abuse, or dependence. After discontinuation of short- and long-term treatment with gabapentin, withdrawal symptoms have been observed, and gabapentin should be discontinued gradually over a minimum of one week.

As with all medicines, the safety of gabapentin is kept under continual review by the Medicines and Healthcare products Regulatory Agency using a number of data sources including reports of suspected side effects through the Yellow Card Scheme, data from marketing authorisation holders, and research published in the scientific literature.