Hold a public inquiry to review the use of dopamine agonists

Hold an inquiry into the use of dopamine agonists covering: impulse control disorders; potential physical harms & misdiagnosis of vascular dementia; & any lessons from past & current criminal proceedings involving dopamine agonist patients. This could lead to concrete reforms to prevent future harm.

It has been reported that some people with Parkinson’s, RLS and related conditions taking dopamine agonists have faced ruined finances, family breakdown, dangerous impulse control disorders, physical decline, misdiagnosis of vascular dementia and, in some cases, criminal proceedings. Many were never warned or properly reviewed. The media have been investigating the issue, but an inquiry could examine the evidence in full, review prescribing and warning standards, and help protect patients in future.

The Government recognises the understandable concern about the potential side effects of dopamine agonists, particularly impulse control disorders, and the significant effect these can have on patients and their families.

Patient safety is our first priority when medicines are prescribed and regulated.

The doctor or other healthcare professional responsible for a patient’s care decides whether to prescribe a medicine and remains accountable for that decision.

Prescribers should explain a medicine’s benefits, risks, possible side effects and other consequences. They should also make sure there are suitable arrangements to monitor the patient and review their treatment.

Prescribers must follow relevant national guidance on effective treatment and consider safety alerts from the Medicines and Healthcare products Regulatory Agency (MHRA). Guidance from the National Institute for Health and Care Excellence says that people with Parkinson’s disease, and their families and carers, should receive spoken and written information about important risks, including impulse control disorders.

The MHRA licenses medicines and checks that they meet the required standards of safety, quality and effectiveness. It also makes sure that clear information is available about how approved medicines should be used.

This includes the Patient Information Leaflet for patients and the Summary of Product Characteristics for healthcare professionals, which contains the relevant information to use the approved medicines.

As part of this responsibility, and given recent concerns raised by stakeholders, the MHRA is currently assessing whether additional regulatory action is required to further raise awareness of the side effects associated with dopamine agonist medications. The Agency has engaged a range of stakeholders, including Parkinson’s UK and RLS-UK, to ensure that patient and carer perspectives are appropriately considered in the review.