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For years, stories have surfaced how a handful of drugs used to treat Parkinson’s disease have been blamed for some unusual side effects, such as sudden sexual urges, compulsive eating and shopping, and pathological gambling. Now, a consumer advocacy group is demanding that the US Food and Drug Administration place serious warnings on the product labeling.

In a petition filed with the agency, Public Citizen says that its review of more than 80 studies warrants so-called Black Box warnings for all six drugs, including Requip and Mirapex. And the consumer group argues that evidence indicates there is a “causal” relationship between these widely used medicines, which are known as dopamine agonists, and impulse-control disorders.

In its analysis of the clinical trials, the consumer group found overall rates of compulsive behaviors varied, ranging from 2.6 percent to 18.4 percent, depending on how Parkinson’s patients were assessed by doctors. But Public Citizen cautioned the results should be interpreted conservatively due to the potential for underreporting, since such symptoms may not be easily associated with the drugs.

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The consumer group also maintained that current labeling is unhelpful, because the risks are described inconsistently, are often easily overlooked or, in some cases, are misleading. Moreover, Public Citizen complained that not all manufacturers distribute what are known as product inserts, which contain cautionary messages about a medicine for patients.

“The current warnings found in the drugs’ labels are far too weak and do not adequately warn prescribers and patients about these serious risks,” Dr. Michael Carome, director of Public Citizen’s Health Research Group, which filed the petition, said in a statement. “The FDA should move swiftly before these side effects devastate any other patients’ lives.”

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The petition reiterated examples found in earlier studies, such as one man, who was prescribed Requip and reportedly demanded his wife have sex several times per day. He also propositioned his daughter’s friend for sex in return for money to relieve her financial difficulties. In addition, he requested that his son and daughter-in-law “form a threesome.”

Then there was a woman who was prescribed Mirapex and “spent all her retirement salary in three days by giving it away to beggars, doing excessive shopping, and playing lotto games.” The petition also cited a report in which a 64-year-old woman who couldn’t stop eating peanuts or chocolate chips after being prescribed the same drug.

We asked GlaxoSmithKline, which sells Requip, and Boehringer Ingelheim, which sells Mirapex, for comment and will update you accordingly.

Meanwhile, Peter Schmidt, senior vice president and chief mission officer at the National Parkinson Foundation, a non-profit patient group wrote us that “while we are pleased that Public Citizen is focusing on a problem that truly affects the lives of people with Parkinson’s, we hope the outcome of this process is not a black-box warning.”

“… While the treatment effects of dopamine agonists can dramatically improve quality of life, patients who experience impulse control disorders because of these medications need to recognize early that those symptoms are being caused by the medication and can usually be effectively addressed by their neurologists,” he said.

As for the FDA, an agency spokeswoman wrote us that the FDA will review the petition and respond directly to Public Citizen. There was no timetable given for when a response would be made. The FDA, by the way, recently issued a public health warning about compulsive behaviors tied to the Abilify antipsychotic, but did not require a Black Box warning.

This is not the first time such warnings have been urged. Two years ago, researchers in a paper in JAMA Internal Medicine found impulse control disorders were more closely associated with the drugs than had been previously demonstrated and called for Black Box warnings. “The associations were significant, the magnitude of the effects was large, and the effects were seen for all six” drugs, they wrote.

Public Citizen, in fact, cited this analysis, which reviewed 2.7 million domestic and foreign side effects that were reported to the FDA between 2003 and 2012. The researchers identified 1,580 that involved behaviors associated with impulse control disorders, including 710 that were identified with dopamine receptor agonists, mostly among men older than 55 years of age, and 870 associated with other drugs.

Using a statistical analysis, the researchers also found the proportion of side effects involving impulsive behavior was 277 times higher than drugs used to treat other central nervous system ailments, such as epilepsy, depression and schizophrenia. Such analyses are often used to identify causal connections in side effect reports, although the researchers acknowledged limitations to this approach.

This post was updated the following day to include a comment from the National Parkinson Foundation.

  • My mother has been on Levadopa for the last 20 years {she is 87] and lately she has been hallucinating a lot. I know is one of the side effects of the drug but am wondering if she can be put on something else.

  • My husband is taking Requip for at least 10 years no. We were warned by his neurologist and are reminded during his repeat visits. It is even on the literature we receive from Rite Aid with each script.
    I am sorry that so many with this awful disease are not better informed, not only by the pharmaceutical company but also by their physicians and local drug stores that are filling their scripts.

  • My husband has experienced all of the side effects of Mirapex. I finally convinced the Dr. To take him off of it. The hallucinations were awful, seeing and talking to his dead parents, kid filling the house, people taking thing. He demanded sex every day, and on a cruise he got so angry at me I thought he would harm me because I would not give him more money for slots.

  • To Whom May Concern
    My name is Mallary Benrube I walk for Parkinson my Boyfriend Joseph Mintzer has Parkinson, I am trying for him to Eat Health Foods and not Fried Food it is not Health. To Eat Fried Food it is bad for your Health a all of people that have Parkinson Disease should eat Health Food do the FDA and Drug . Thank you Mallary Benrube

  • My mother suffered significant drug reaction with one dose of a Parkinson drug. She was an inpatient. Acting out sexually, also hallucinations. My mother saw her deceased mother and my deceased father. I was aware this was a drug interaction. The RN was not familiar. The neurologist stopped the drug. I agree the package warnings and more education is needed.

  • My husband and I are very angry that this is still an issue because we started a lawsuit over 15 years ago!!! We lost everything even our self respect. We settled in court and got the warning put on but not the one we thought. This should’ve been taken care of. We spoke for days to lawyers and the drug reps about the horrors that this drug caused us and others in the suit. We were on tv and in People magazine warning others about these atrocious side effects. The fact that this is still an issue is both disgusting and heart-breaking.

    • Wow, that is so devastating And it is so unfair that people who were warned are complaining — ok, I get that — but I don’t know if they understand those of us who had no idea why we were gambling and lost everything. The drug company knew, but kept it secret. And we haven’t been reimbursed by law! It’s insane. I can’t believe you are still dealing with it. I gave up, but if you think there’s a chance I could still get involved, please let me know what you think. I did shred and trashed all my paperwork, however. That damned attorney sent it all back to me in a big box!

  • My husband, who has Parkinson’s, was on one of these and the Dr. told us right away to watch for addictive behavior. He became addicted to chocolate chips and peanuts also. He was very thin at the time but it quickly got out of control, he gained 40lbs in 6 months. He didn’t want to go off the medicine so I have to be very diligent in what I bring into the house to eat. He’s gotten a lot better with it and has started to lose some of the weight. We were fortunate that we had a very informed Doctor who was up on all the latest findings.

    • I’m sorry this happened to you. But you were warned and those of us who it happened to before the drug companies admitted to the problem, we gambled our finances, homes, kids’ money, everything — had to sell what was left. I’d sure rather be gaining weight on chocolate chips. I’m not belittling you at all, it’s just that we should have been compensated when the drug companies already knew about this side effect and we were caught in it. No warnings.

  • I cannot believe this has not happened yet! I lost everything I ever had including money from my mother because of a gambling addiction that came out of nowhere after being put on one of these meds in the early 2000’s. I was in a lawsuit (I lived in MN) and it was a large suit being done by an attorney’s office in CA. After spending months upon months of communicating with them, getting all the receipts and other necessary paperwork done (and it’s a lot!), the trial was finally coming up. At the last second — literally the day before — the attorney’s office dropped me! Their excuse was that I couldn’t prove MN’s minimum amount lost. Oh, yes I could have…but the attorney never told me about that and never gave me/taught me how — the chance to provide all the proof. I got ripped off by the drug company (there were NO warnings or talk of this side effect then, but the drug company knew about it) and I got ripped off by the attorney. I was stuck. I am so angry. I am disabled and have nothing. I have a feeling the people who got in on the case to the end were probably the rich people. If you can help me, please let me know. This was a horrible thing and I needed that medication. I ultimately landed on opioids for uncontrollable RLS.

    • Your attorney did you a disservice. As soon as the gambling became apparent your mother should have petitioned the court to become guardian and she would have had 100% control of your finances. Also there are non opioids for RLS. But that’s another issue.

    • Unless you lost everything overnight this should have come to the attention of a competent neurologist. They are trained to look for impulse control symptoms with these drugs and you would have been switched to L-Dopa, which doesn’t cause this problem.

    • This was prior to drug companies admitting there were impulse problems possible. My doc was a top neuro at the Mayo Clinic in MN. He didn’t know…docs often know less about the effects of medicine than pharmacists anyway. But it was too early.

    • This was prior to drug companies admitting there were impulse problems possible. My doc was a top neuro at the Mayo Clinic in MN. He didn’t know…docs often know less about the effects of medicine than pharmacists anyway. But it was too early. My mom was not able to take my money in her hands; she was helping to support me because I was on disability. Non-opioids were and are used, 2400 mg gabapentin, 1000-2000mg magnesium, no caffeine, no alcohol…and everything else I’ve every found to help.

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