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- author, Noel Titheridge and Curtis Lancaster
- scroll, BBC News
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Twenty women told the BBC that the medications prescribed to them to treat restless legs syndrome, which causes an irresistible urge to move, had ruined their lives.
A report issued by the pharmaceutical company GSK – seen by the BBC – shows that the company became aware in 2003 of a link between the drugs, known as dopamine agonists, and what it described as “non-standard” sexual behaviour. The report cites the case of a man who sexually assaulted a child while taking Parkinson’s medication.
Although there is no explicit reference to this side effect in the leaflet, the UK Medicines Regulatory Authority told the BBC that there is a general warning about increased sexual desire and harmful behaviour. GlaxoSmithKline, in turn, says that the risk of “altered” sexual interest is also mentioned in the leaflet.
Some women told the BBC they had been drawn into risky sexual behaviour, and said they had no idea why. Others reported feeling forced to bet or buy, without having a history of such activities. One of them has accumulated debts of more than £150,000 (about R$1.1 million).
Like many women, Claire developed restless legs syndrome during pregnancy. The constant need to move was often accompanied by restlessness and a crawling sensation under the skin.
The condition persisted after birth and was treated with the dopamine agonist ropinirole. She says that doctors did not warn her about the side effects. At first, the medication was effective in treating restless legs syndrome, she says, but after a year or so, she started experiencing unprecedented sexual urges.
“The only way to describe it is that it was out of the ordinary,” she told the BBC, using that term without any knowledge of GlaxoSmithKline’s research that had proven a link to the behaviour.
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Claire says she started leaving the house in the early hours of the morning in search of sex. She was wearing a see-through shirt and jacket, and would show her chest to any man she met. She says she did this regularly, and in increasingly dangerous places, despite having a partner.
“There’s still an element in your head that knows what you’re doing is wrong, but it affects you to the point where you don’t even know you’re doing it.”
It took many years to associate these urges with the medication, and they went away almost immediately when she stopped taking them, says Claire. She feels completely “ashamed” and “scared” of the dangerous situation she has put herself in.
Impulsive behaviors, including gambling and increased sexual desire, have long been listed as side effects in the literature for dopamine agonist medications — and are thought to affect 6% to 17% of restless legs syndrome patients who take these drugs, according to a British health advisory body. It is considered a ‘common’ side effect of any medication affecting just 1% of people who take it, according to the UK’s public healthcare system.
The medications work by mimicking the behavior of dopamine, a natural brain chemical that helps regulate movement. It is known as the “happiness hormone” because it is activated when something is pleasurable or when we feel rewarded.
But agonist medications can overstimulate these sensations and encourage underestimation of consequences, leading to impulsive behavior, according to the academics.
The cases that a 2003 GlaxoSmithKline report described as “nonstandard behavior” involved two men taking ropinirole to treat Parkinson’s disease. In one, a 63-year-old man sexually assaulted a seven-year-old girl, resulting in him being sentenced to prison.
The documents say the attacker’s sexual desire had increased significantly since he began treatment with ropinirole, and that his “libido problem subsequently resolved” after the dosage was reduced.
In the second case, a 45-year-old man engaged in “exhibitionist acts and inappropriate, uncontrollable behavior.” His sexual desire reportedly increased before Ropinirole was prescribed, but his urges “intensified” after treatment.
The prevalence rates of what GlaxoSmithKline calls “non-standard” sexual behaviors caused by the drugs are unknown, and tend to go unreported by those experiencing side effects, according to Valerie Vaughn, a professor of neuropsychiatry at the University of Cambridge in the United Kingdom.
“There’s a lot of stigma and shame associated with this, and people don’t realize that this is linked to medications,” she explains.
Vaughn believes risky sexual behaviors – other than simply increased sexual desire – should be specifically warned by patients, and analyzed by the NHS, because their impact can be “devastating”.
Restless legs syndrome is thought to affect one in 20 adults, and women are twice as likely to develop the condition as men.
The 20 patients the BBC spoke to said that doctors not only did not inform them of the potentially serious side effects of the drugs, but also did not analyze the effect of the drug on their bodies afterwards.
Sarah was 50 years old when she was prescribed another dopamine agonist medication from a different manufacturer.
“Before, I didn’t care if Brad Pitt walked into the room naked,” she says. “But she turned me into a fierce woman who continued her sexual addiction.”
Sarah began selling used lingerie and sex videos online – and arranging phone sex with strangers. She also began shopping compulsively, ending up with £30,000 in debt.
To combat the effects of the dopamine agonist, she began self-medicating by taking opioid pain relievers and sleeping pills. She ended up entering rehab, but this meant she lost her driver’s license and her job.
She told the BBC: “I resorted to things that were not healthy. I knew this behavior was not mine, but I could not control it.”
A third woman, Sue, claims she was prescribed two different dopamine agonist medications, but was not warned of the side effects associated with compulsive behaviors on both occasions. She says she mentioned her recent habit of betting when the second medication was prescribed. She ran up debts of £80,000 (about R$600,000) from gambling.
“The impact on my family was terrible,” she says. “Losing that money changed my life.” “But at the time, I didn’t know it wasn’t my fault.”
A class action lawsuit was filed against GlaxoSmithKline in 2011 by four Parkinson’s patients, the BBC has learned. They said ropinirole led to gambling debts and the end of relationships.
They also complained that although a relationship between these behaviors and the drug had been demonstrated in medical studies as early as 2000, GSK did not include any warnings in the product literature until March 2007. The class action lawsuit was resolved in the settlement, but GSK denied liability.
Cases of serious side effects have also been reported in other countries, especially with regard to the use of Parkinson’s medications.
In France, a court awarded compensation to a father of two who complained that Ropinirole aroused compulsive homosexual urges, while another man with no criminal record began torturing cats.
In the United States, the American Academy of Sleep Medicine recommends the use of medications only for short-term treatments, such as palliative care for terminally ill patients.
Several women the BBC spoke to complained that long-term use of the drugs also worsened restless legs syndrome. This meant increasing the dose, which in turn exacerbated the compulsive behavior.
Neurologist Jay Lechziner says medications still play an important role, but he believes drug companies, health authorities and doctors need to better warn patients about these side effects.
“Not everyone is aware of the kinds of radical changes that can happen,” he says.
In a statement, GlaxoSmithKline told the BBC that ropinirole had been prescribed for more than 17 million treatments and had undergone “extensive clinical trials.” The company added that the drug has proven effective and has “good safety specifications.”
He added: “As with all medicines, it has potential side effects, which are clearly stated in the leaflet information.”
In response to its 2003 research, which found a link to “non-standard” sexual behaviour, GlaxoSmithKline told the BBC that this had been shared with health authorities, and issued updates to the leaflet’s information – which now lists “changed or increased sexual interest” and “behaviour of significant concern” as side effects.
The current label for ropinirole specifically refers to changes in sexual interest on five occasions – and warns almost exclusively of the frequency or intensity of these sensations, as likely to be “abnormally high,” “excessive,” or “increased.”
The UK Medicines and Healthcare Products Regulatory Agency, MHRA, said that although there is no specific reference to “non-standard” sexual behavior in the warnings, these motivations vary, and there is a general warning about potentially harmful activities.
The agency also said it’s important for health care professionals to explain the potential risks to patients — and that not everyone experiences these types of side effects.
The Ministry of Health and Social Welfare declined to comment.
Some names in this report have been changed to protect people’s identities.