Mirapex, ReQuip, Etc. Should Have Prominent Black Box Warnings About Serious "Psychotic-like," Compulsive Behavior | Pharmaguy's Insights Into Drug Industry News | Scoop.it

For several years, a group of drugs used to treat Parkinson’s disease has been blamed for various unusual addictive behaviors, such as pathological gambling, compulsive shopping and sudden sexual urges. Sensational stories occasionally appeared in the media and lawsuits were filed by patients who blamed the drugs, such as Requip and Mirapex, for wreaking havoc on their lives.


Now, a new analysis suggests in JAMA Internal Medicine finds these widely used drugs. known as dopamine receptor agonists, are more closely associated with these impulse control disorders  than has been demonstrated. Consequently, the study authors are calling for stronger warnings – specifically, so-called Black Box warnings, which are the most serious type of warning – to be added to product labeling.


In reaching their conclusions, the researchers analyzed 2.7 million domestic and foreign side effects for all drugs reported to the FDA between 2003 and 2012. 


Using a statistical analysis they found the proportion of side effects involving impulse control behaviors was 277 times higher than other central nervous system drugs, such as those used to treat depression, schizophrenia and epilepsy. 


“The associations were significant, the magnitude of the effects was large and the effects were seen for all six” of the dopamine receptor agonists, they wrote. And they conclude by noting that none of these six drugs currently have boxed warnings about impulse control disorders, but that such warnings should be added based on their findings, as well as small studies indicating the reasons for the side effects may go unrecognized.


“This is a striking example of an unusual and very specific set of psychiatric side effects linked to drugs that effect a specific neuroreceptor,” lead author Thomas Moore, a senior scientist at the Institute for Safe Medicine Practices, a non-profit, writes us.“In some patient groups, 10% to 15% may experience this potentially catastrophic side effect, a rate of injury that is extremely high.”


The association was strongest for the dopamine agonists pramipexole [Mirapex] (n = 410; PRR = 455.9, P < .001) and ropinirole [ReQuip] (n = 188; PRR = 152.5, P < .001)