These Impulse Side Effects, As Seen In Adverse Drug Events Reports, Are Much Higher Than Previously Thought According To New Medical Journal Article
(Posted by Tom Lamb at DrugInjuryWatch.com)
Thomas Moore, A.B., a senior scientist at the Institute of Safe Medication Practices (ISMP), together with his fellow authors of a new medical journal article are calling for the addition of a so-called "black-box" warning to the drug labels for Mirapex, Requip, Neupro, and other medications used for Parkinson's disease and restless leg syndrome.
Based on their findings about impulse control problems associated with these "dopamine agonists" drugs, they think there should be a heightened warning about unusual side effects in the form of compulsive behaviors involving gambling, shopping, and sex.
This new medical journal article is "Reports of Pathological Gambling, Hypersexuality, and Compulsive Shopping Associated With Dopamine Receptor Agonist Drugs", which was published online October 20, 2014 by the medical journal JAMA Internal Medicine.
From an October 21, 2014 news report by HealthDay, "Parkinson's Drugs May Spur Compulsive Behaviors", we get this commentary and insight:
Drugs commonly used to treat Parkinson's disease may raise the risk of so-called impulse control disorders, according to a new review.
These disorders include compulsive gambling, compulsive shopping and/or hypersexuality.
That increased risk was seen in a fresh review of a decade's worth of U.S. Food and Drug Administration (FDA) records....
The study's authors stressed that these medicines are widely used to treat a range of illnesses, including Parkinson's, restless leg syndrome and patients diagnosed with high levels of the hormone prolactin -- which can cause impotence in men and can prevent pregnancy in women.
More than 2 million such prescriptions were filled during the last three months of 2012 alone, the researchers noted....
Nearly 45 percent of [710 "serious" impulse control adverse drug events reports made to FDA] were linked directly to the use of any of six different dopamine receptor agonist medications, with most involving male patients (more than 65 percent) at an average age of 55. The other 55 percent of cases were associated with the use of other medications, the study found.
More than 60 percent of the time, the impulse control cases involving dopamine receptor agonists were patients struggling with Parkinson's, while nearly a quarter involved patients with restless leg syndrome, the researchers said.
Breaking it down, the team identified 628 instances of pathological gambling, 465 cases of hypersexuality, and 202 examples of compulsive shopping.
"I should say that the risk for these events does not appear to be rare at all," said Moore. "These psychiatric side effects appear to occurring among at least 10 percent of patients. If you compare that with, say, the risk for suicide among patients who take antidepressant drugs, this is much higher. It's an astronomical rate, in terms of drug adverse event risk. And frankly I think I'm being conservative."
In fact, some patients have sued the manufacturer of Mirapex, Boehringer Ingelheim, alleging that this Parkinson's disease drug triggered their pathological gambling which resulted in significant economic damages and other losses.