Restless Legs Syndrome: Drugs

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring that medicines and healthcare products meet appropriate standards of safety, quality, and effectiveness and are supported by detailed product information, via the Patient Information Leaflet (PIL) and the Summary of Product Characteristics (SmPC). The PIL and SmPC are designed to support safe use of the medicine by providing essential information. It is the responsibility of the healthcare professional prescribing medicines to consider the risk of the medicine and the suitability of that medicine for their patient, and to relay any safety information on the side-effects of the medicine to their patient.

The association between impulse control disorders with dopamine agonists is recognised and it’s recommended that patients should be regularly monitored and also made aware of the risk of impulse control disorders. These risks are outlined in the product information for all dopamine agonists.

The MHRA is considering whether further regulatory action is needed to improve awareness and understanding of the established risks of impulse control disorders among patients and healthcare professionals. This work does not reassess the safety of these medicines, but focuses on whether additional regulatory measures could strengthen communication of these risks.

The National Institute for Health and Care Excellence (NICE) is responsible for producing guidance for the National Health Service and wider health and care system. The NICE guideline, reference code NG71, covers diagnosing and managing Parkinson's disease in people aged 18 years old and over and includes advice about discussing the risks of impulse control disorders. The NICE guideline is available at the following link:

https://www.nice.org.uk/guidance/ng71/chapter/Recommendations