Subject: Request for Meeting with the MHRA Review Team on Dopamine Agonists
8 June 2026
Dear Dr Cave and Colleagues,
We are writing on behalf of the Dopamine Agonist Action Group and the growing number of patients and families across the United Kingdom whose lives have been profoundly affected by dopamine agonist medications. We welcome the MHRA's current review of dopamine agonists. It represents a once-in-a-generation opportunity to address a patient safety issue that has affected patients for more than two decades and which, despite repeated warnings from patients, researchers and advocacy organisations, has not been adequately recognised or acted upon.
We therefore formally request a meeting with the review team so that the voices of those directly affected can be considered before conclusions are reached and recommendations finalised.
Our organisation was founded by individuals with lived experience of these medications and their consequences. Through our work, we have also been contacted by many patients, former patients, carers and families affected by dopamine agonist-associated harms across multiple conditions. Together, these experiences provide a unique perspective on the real-world impact of impulse control disorders, augmentation and dopamine agonist withdrawal syndrome, including many cases that have never been captured through formal reporting systems.
For many patients prescribed dopamine agonists for Restless Legs Syndrome (RLS), Parkinson's disease and other conditions, the consequences can be devastating. Patients experience a range of clinical, behavioural and social harms, including:
Impulse Control Disorders (ICDs), including pathological gambling, hypersexuality, compulsive shopping and binge eating;
Severe financial losses, debt and bankruptcy;
Relationship breakdown and family trauma;
Loss of employment and professional standing;
Psychological injury, shame and social isolation;
Dopamine agonist withdrawal syndrome;
Augmentation in patients treated for RLS, where the medication itself progressively worsens the condition it was intended to treat.
The human cost is enormous.
We believe the true scale of the problem remains significantly underestimated. ICDs are uniquely prone to under-reporting because they involve behaviours associated with shame, stigma, secrecy and guilt. Families often do not recognise the connection between the medication and the behaviour until years later. Clinicians frequently fail to identify the signs. As a result, clinical studies and spontaneous reporting systems such as the Yellow Card scheme may not fully reflect the true prevalence of harm. The MHRA review therefore has an opportunity to correct what may be decades of under-recognition.
The review must also fully address the potentially devastating impact of augmentation. It is a treatment-induced worsening of disease that can leave patients in a state of exhaustion, distress and desperation. Many patients prescribed dopamine agonists for RLS find themselves trapped in a cycle of escalating symptoms, increasing doses and increasingly difficult withdrawal.
We are particularly concerned that clinical practice has not kept pace with emerging evidence.
The publication of the updated Mayo Clinic Proceedings algorithm in May 2026 represents a significant milestone. The new guidance places iron assessment and treatment at the centre of RLS management, recommends gabapentinoids as first-line pharmacological therapy for chronic persistent RLS, and explicitly highlights the risks associated with dopamine agonists and the precautions required if they are used. In addition to patient safety benefits, earlier identification and treatment of iron deficiency may also reduce long-term healthcare costs associated with prolonged medication use and the management of treatment-related complications and adverse effects.
In our view, this updated evidence base should now drive change across the United Kingdom.
We urge the MHRA to work with NICE, NHS England, Royal Colleges, specialist societies and patient organisations to ensure that:
1. Dopamine agonists are never presented as routine first-line treatment for RLS.
2. Iron deficiency and iron replacement therapy are prioritised in diagnosis and treatment pathways.
3. Prescribers receive mandatory education regarding augmentation and impulse control disorders.
4. Patients and families receive clear, explicit and repeated warnings regarding behavioural side effects.
5. Structured monitoring programmes are introduced, including regular screening for ICDs and augmentation.
6. Withdrawal and tapering pathways are developed for affected patients.
7. Future patient information leaflets accurately reflect current evidence regarding prevalence and severity of harms.
The MHRA has an opportunity to make a meaningful contribution to patient safety by ensuring that lived experience, real-world outcomes and published evidence are considered together. For many affected patients and families, this review represents a rare and important opportunity to examine these issues comprehensively and independently.
We believe the experiences of affected patients and families are an essential part of this review and should be considered alongside the published evidence. We therefore request an opportunity to meet with the review team before recommendations are finalised. This perspective can help ensure the review fully captures the prevalence and consequences of these harms and informs recommendations that better protect patients and minimise future harm.
Yours faithfully,
Emma Sanderson-Nash PhD
Chair
