26
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      Comparison of Quetiapine Abuse and Misuse Reports to the FDA Adverse Event Reporting System With Other Second-Generation Antipsychotics

      research-article

      Read this article at

      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          Background:

          Second-generation antipsychotics (SGAs) are assumed to have little abuse potential. However, reports of quetiapine abuse have emerged as prescribing has increased in recent years. The US Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS) provides postmarketing information regarding adverse drug events (ADEs). This is the first study to analyze quetiapine abuse-related ADEs reported to FAERS to determine whether a disproportionate rate of such events have been reported when compared with other commonly used SGAs.

          Methods:

          A cross-sectional analysis of FAERS data from January 1, 2015, to December 31, 2017, was performed. The total number of all-cause and abuse-related ADEs reported to FAERS regarding quetiapine, olanzapine, aripiprazole, and risperidone were identified, along with demographic and mortality data. The proportional reporting ratio (PRR) was calculated to assess disproportionate reporting of abuse-related adverse drug reactions between quetiapine and each of three alternative SGA medications.

          Results:

          Abuse-related ADEs represented 11% (3144/27 962) of total ADEs reported for quetiapine, 8% for olanzapine (1548/19 228), 5% (1380/29 699) for aripiprazole, and 3% (1168/45 518) for risperidone. The PRRs (95% confidence interval) for quetiapine versus olanzapine, aripiprazole, and risperidone were 1.40 (1.32-1.48), 2.42 (2.28-2.57), and 4.38 (4.10-4.68), respectively, indicating that abuse-related events were significantly more likely to be reported with quetiapine than each comparator drug. In addition, more deaths were reported among the abuse-related events regarding quetiapine (673) than olanzapine (200), aripiprazole (88), and risperidone (143).

          Conclusion:

          This study corroborates recent evidence indicating that quetiapine might possess a significantly higher abuse potential than other commonly used SGAs. Although prospective studies are needed to better understand the abuse potential of quetiapine, increased vigilance in monitoring for signs of substance abuse might be warranted when prescribing quetiapine.

          Related collections

          Most cited references11

          • Record: found
          • Abstract: found
          • Article: not found

          Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports.

          The process of generating 'signals' of possible unrecognized hazards from spontaneous adverse drug reaction reporting data has been likened to looking for a needle in a haystack. However, statistical approaches to the data have been under-utilised. Using the UK Yellow Card database, we have developed and evaluated a statistical aid to signal generation called a Proportional Reporting Ratio (PRR). The proportion of all reactions to a drug which are for a particular medical condition of interest is compared to the same proportion for all drugs in the database, in a 2 x 2 table. We investigated a group of newly-marketed drugs using as minimum criteria for a signal, 3 or more cases, PRR at least 2, chi-squared of at least 4. The database was used to examine retrospectively 15 drugs newly-marketed in the UK, with the highest levels of ADR reporting. The method identified 481 signals meeting the minimum criteria during the period 1996-8. Further evaluation of these showed that 70% were known adverse reactions, 13% were events which were likely to be related to the underlying disease and 17% were signals requiring further evaluation. Proportional reporting ratios are a valuable aid to signal generation from spontaneous reporting data which are easy to calculate and interpret, and various refinements are possible.
            Bookmark
            • Record: found
            • Abstract: not found
            • Article: not found

            The FDA and the Next Wave of Drug Abuse — Proactive Pharmacovigilance

              Bookmark
              • Record: found
              • Abstract: found
              • Article: not found

              Reports of gabapentin and pregabalin abuse, misuse, dependence, or overdose: An analysis of the Food And Drug Administration Adverse Events Reporting System (FAERS)

              Reports of gabapentinoid (gabapentin and pregabalin) misuse have increased in recent years. Pharmacovigilance data from the Food and Drug Administration Adverse Event Reporting System (FAERS) provides a useful examination of adverse drug event (ADE) reporting for safety signal detection.
                Bookmark

                Author and article information

                Journal
                Subst Abuse
                Subst Abuse
                SAT
                spsat
                Substance Abuse: Research and Treatment
                SAGE Publications (Sage UK: London, England )
                1178-2218
                01 May 2019
                2019
                : 13
                : 1178221819844205
                Affiliations
                [1 ]Division of Pharmacotherapy, College of Pharmacy, The University of Texas at Austin, Austin, TX, USA
                [2 ]Department of Pharmacy, University Health System, San Antonio, TX, USA
                [3 ]Pharmacotherapy Education and Research Center, Long School of Medicine, University of Texas Health San Antonio, San Antonio, TX, USA
                [4 ]Research Service, South Texas Veterans Health Care System, San Antonio, TX, USA
                Author notes
                [*]Kirk E Evoy, Long School of Medicine, University of Texas Health San Antonio, 7703 Floyd Curl Dr, MSC-6220, San Antonio, TX 78229, USA. Email: evoy@ 123456uthscsa.edu
                Author information
                https://orcid.org/0000-0001-9239-2125
                Article
                10.1177_1178221819844205
                10.1177/1178221819844205
                6495438
                60ca0e6e-cc39-4e11-a6ad-3e2b4855e5c4
                © The Author(s) 2019

                This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ( http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

                History
                : 4 February 2019
                : 7 February 2019
                Categories
                Original Research
                Custom metadata
                January-December 2019

                Health & Social care
                quetiapine,olanzapine,risperidone,aripiprazole,prescription drug abuse,faers,adverse event reporting system,second-generation antipsychotics

                Comments

                Comment on this article