Specialist medical negligence solicitors who have been contacted by more than 100 people who have experienced compulsive behaviour after taking medication for conditions including restless leg syndrome have now written to a regulator urging it to improve the information available to patients.

A joint letter from Switalskis, which was also signed by a respected professor of Clinical Psychiatry, professor or Clinical Pharmacy and a GP expert, has flagged the concerns to the Medicines and Healthcare Products Regulatory Agency (MHRA) with regard to the medications, with particular reference to ropinirole, rotigotine, pramipexole and aripiprazole.

The medications can be prescribed by neurologists or general practitioners (GPs) for conditions such as restless legs syndrome (RLS) and Parkinson’s disease, while aripiprazole is commonly prescribed by psychiatrists for conditions such as bipolar disorder and schizophrenia.

The letter to the MHRA was signed for Switalskis by clinical negligence solicitor Kimberley Davies , who is working with dozens of patients who have suffered impulse control disorders including gambling, reckless spending and hypersexual behaviour. The other signatories to the letter have also seen multiple patients experiencing similar side-effects.

Many patients have suffered a range of other issues as a result of their change in behaviour, including a decline in their mental health, serious financial problems, inability to work and even bankruptcy in some cases and irreparable damage to their relationships and friendships.[KD2]  

Impulse control disorders are a known side-effect of the medications. Patients should get clear warnings about the possible side-effects before they are prescribed, and should be reminded of this at regular medication reviews, but evidence suggests that many people have not been given those warnings.

Switalskis has already gained a settlement for one patient who was prescribed pramipexole for her RLS condition and then, later, ropinirole but wasn’t warned about the possible side effects. She went on to develop a compulsive gambling habit before contacting our specialists, who secured her a £70,000 settlement for her financial losses and the distress she suffered.

Our experts are also working on the final stages of another case where a woman was prescribed ropinirole for her RLS and again, wasn’t warned of the side-effects. She too proceeded to develop a compulsive gambling habit and Switalskis has now secured an admission from the Welsh Health Board after the woman’s GP admitted failing to warn her about the side-effects of the medication.

A four-step plan to help patients: what our letter calls for

All three signatories have urged the MHRA to take four urgent steps to improve the information and support given to patients prescribed the named medications by GPs and other medical professionals, including:

1. Discussing the risks in detail with the patient, and with family where appropriate, when the medication is first prescribed and clearly record that they have done so, as well as ensuring patients understand what an impulse control disorder is, giving examples and urging them to seek immediate help if they experience a change in their behaviour.
2. Carrying out regular medication reviews which, as a minimum, should be conducted annually with an expectation that the clinician specifically asks patients at these reviews about any impulse control behaviours.
3. At such medication reviews, questions should be framed in a non-judgemental way so as to minimise the risk that a patient fears disclosing any issues, particularly if they are accompanied by a partner or family member. Patients who may be reluctant to change the medication because it has been effective can be informed that dose reduction may relieve the impulse control disorder and that there are alternative medications that can be tried.
4. When any patient presents with difficulties with impulse control, treatment should be reviewed as soon as possible. This includes a check of the medication they are taking, and consideration given to whether this could be a factor or cause. If the medication is a factor, then options include de-prescribing including dose reduction and switching to a different class of medication.

 ‘Considerable and often irreparable damage to their lives’

The letter to the MHRA was signed by Professor Christopher Fox, a Professor of Clinical Psychiatry at Exeter University, Ian Maidment, professor of Clinical Pharmacy AT Aston University and general practitioner Dr Alastair Bint, alongside Kimberley Davies, an associate solicitor in Switalskis’ medical negligence team who has dealt with more than 100 requests for help from people suffering impulse control disorders (ICDs) after taking one of the medications, often referred to as dopamine agonists.

The letter outlines the seriousness of the issue, saying: “Our concern is that many patients seem to have not been warned of these risks when the medication was first prescribed. When their behaviour changes, they are therefore unable to connect that to their medication, and so do not seek help, until their behaviour has caused considerable and often irreparable damage to various aspects of their lives”.

“Patients who suffer from an ICD tend to become consumed by an irresistible urge to perform such behaviours, most commonly pathological gambling but also excessive and wasteful spending, binge eating, and reckless hypersexual behaviour. In most cases, these behaviours start within days of starting the medication, but others have begun months later with no obvious trigger”.

“We have seen many cases where patients have lost hundreds of thousands of pounds in only a few months, with consequential devastating effects on their families, friendships and careers. We are aware of people losing their homes, spending their entire pension fund, their life savings, and facing bankruptcy”.

“We know of people who have lost their month’s pay within hours of receiving it; others who have spent entire days in the office, hiding in the bathroom, gambling online. In the cold light of day, many regret their gambling, and set up barriers to prevent them from placing further bets, only to feel the urge again, and so set up accounts in the names of other people, or with off-shore, unlicensed gambling websites.”

‘Unaware of the risk’: our expert’s view

Drawing on her own experience of having handled more than two dozen cases so far of people who have suffered from the side-effects of dopamine agonist medications, Kimberley said: “In most of these cases, the patient was unaware of the risk and their clinical records show no evidence that they were warned at the outset, or that the risk was mentioned at medication review. That’s very worrying indeed”.

“In many cases, even where a patient sought help about their gambling or other damaging behaviour, it seems that prescribers were still unaware of the possible cause. The patient was simply referred to gambling support services, without any review of their medication. Occasionally, the dose has even been increased in response to the complaint of these harmful behaviours”.

“Many patients have connected their behaviour with the medication only through their own research. In some cases, even where the prescriber or the patient suspect the reaction is due to the medication, the patient has been switched from one dopamine agonist to another, with the same risk of reactions and side-effects, and without any benefit, with the harmful behaviour continuing.”

She added that warnings had been given in guidance from the British National Formulary, a medicines reference used by doctors, pharmacists, nurses, and other healthcare professionals in the UK. It has issued instructions which warn prescribers that “Patients and their carers should be informed about the risk of impulse control disorders ”. The guidance also explains what is meant by impulse control disorder and advises against switching between drugs in the same class,

But Kimberley said: “Sadly, it seems that many prescribers are failing to warn of these risks, in spite of the information being readily available for many years. Many patients are suffering terrible harm as a result”.

“It’s now vital that the MHRA does all it can to remind prescribers and clinical staff of the possible adverse reaction to these medications to avoid any more patients suffering from the impulse control disorders we have seen in so many people so far.”