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      Publicity and reports of behavioral addictions associated with dopamine agonists

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          Abstract

          Background

          The development of behavioral addictions (BAs) in association with dopamine agonists (DAs, commonly used to treat Parkinson’s disease) has been reported. A recent report presented data that these associations are evident in the US Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS), a database containing information on adverse drug event and medication error reports submitted to the FDA. However, given that vulnerability to publicity-stimulated reporting is a potential limitation of spontaneous reporting systems like the FAERS, the potential impact of publicity on reporting in this case remains unclear.

          Method and aims

          To investigate the potential impact of publicity on FAERS reporting of BAs in association with DAs (BAs w/DAs) as presented by Moore, Glenmullen, and Mattison (2014), news stories covering a BA/DA association were identified and compared with BA w/DA and other reporting data in the FAERS.

          Results

          Fluctuations in the growth of BA w/DA reporting to the FAERS between 2003 and 2012 appear to coincide with multiple periods of intensive media coverage of a BA/DA association, a pattern that is not evident in other reporting data in the FAERS.

          Discussion/Conclusions

          Publicity may stimulate reporting of adverse events and premature dismissal of the potential influence of publicity on reporting may lead to mistaking an increased risk of an adverse event being reported for an increased risk of an adverse event occurring.

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          Most cited references 8

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          Pathological gambling caused by drugs used to treat Parkinson disease.

          Pathological gambling is a rare potential complication related to treatment of Parkinson disease (PD). However, the etiology of this behavior is poorly understood. To examine the relationship between medical therapy for PD and pathological gambling. In our routine movement disorders practice (2002-2004), we encountered 11 patients with idiopathic PD who had recently developed pathological gambling. We assessed the relationship to their medical therapy and compared them with cases identified by systematic review of the existing literature on pathological gambling and PD. All 11 patients with PD and pathological gambling were taking therapeutic doses of a dopamine agonist; 3 of these patients were not treated with levodopa. In 7 patients, pathological gambling developed within 3 months of starting to take or escalating the dose of the agonist; in the other 4 with a longer latency, gambling resolved after the agonist use was discontinued. Pramipexole dihydrochloride was the agonist in 9 of 11 cases in our series and 10 of 17 in the literature (68% in total). Dopamine agonist therapy was associated with potentially reversible pathological gambling, and pramipexole was the medication predominantly implicated. This may relate to disproportionate stimulation of dopamine D(3) receptors, which are primarily localized to the limbic system.
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            Pathological gambling associated with dopamine agonist therapy in Parkinson's disease.

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              Reports of pathological gambling, hypersexuality, and compulsive shopping associated with dopamine receptor agonist drugs.

              Severe impulse control disorders involving pathological gambling, hypersexuality, and compulsive shopping have been reported in association with the use of dopamine receptor agonist drugs in case series and retrospective patient surveys. These agents are used to treat Parkinson disease, restless leg syndrome, and hyperprolactinemia. To analyze serious adverse drug event reports about these impulse control disorders received by the US Food and Drug Administration (FDA) and to assess the relationship of these case reports with the 6 FDA-approved dopamine receptor agonist drugs. We conducted a retrospective disproportionality analysis based on the 2.7 million serious domestic and foreign adverse drug event reports from 2003 to 2012 extracted from the FDA Adverse Event Reporting System. Cases were selected if they contained any of 10 preferred terms in the Medical Dictionary for Regulatory Activities (MedDRA) that described the abnormal behaviors. We used the proportional reporting ratio (PRR) to compare the proportion of target events to all serious events for the study drugs with a similar proportion for all other drugs. We identified 1580 events indicating impulse control disorders from the United States and 21 other countries:710 fordopamine receptor agonist drugs and 870 for other drugs. The dopamine receptor agonist drugs had a strong signal associated with these impulse control disorders (n = 710; PRR = 277.6, P < .001). The association was strongest for the dopamine agonists pramipexole (n = 410; PRR = 455.9, P < .001) and ropinirole (n = 188; PRR = 152.5, P < .001), with preferential affinity for the dopamine D3 receptor. A signal was also seen for aripiprazole, an antipsychotic classified as a partial agonist of the D3 receptor (n = 37; PRR = 8.6, P < .001). Our findings confirm and extend the evidence that dopamine receptor agonist drugs are associated with these specific impulse control disorders. At present, none of the dopamine receptor agonist drugs approved by the FDA have boxed warnings as part of their prescribing information. Our data, and data from prior studies, show the need for more prominent warnings.
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                Author and article information

                Journal
                jba
                Journal of Behavioral Addictions
                J Behav Addict
                Akadémiai Kiadó (Budapest )
                2062-5871
                2063-5303
                March 2016
                12 December 2015
                : 5
                : 1
                : 140-143
                Affiliations
                [1 ]Independent Consultant, Boston, MA, USA
                [2 ]Departments of Psychiatry, Neurobiology and Child Study Center , Senior Scientist, CASAColumbia, Yale School of Medicine, New Haven, CT, USA
                Author notes
                [* ]Corresponding author: Katherine E. Gendreau, MPH; E-mail: katherine.gendreau@ 123456aya.yale.edu
                Article
                10.1556/2006.5.2016.001
                5322993
                26690325
                © 2016 Akadémiai Kiadó, Budapest
                Page count
                Figures: 2, Tables: 0, Equations: 0, References: 12, Pages: 14
                Funding
                Funding sources: Supported by a Center of Excellence Grant from the National Center for Responsible Gaming, an unrestricted research gift from Mohegan Sun Casino, the Connecticut Department of Mental Health and Addiction Services, and the Connecticut Mental Health Center. The content of the manuscript does not necessarily reflect the views of the funding agencies, and these agencies did not contribute to the content of this manuscript.
                Categories
                Brief Report

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