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

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.

Rhabdomyolysis Associations with Antibiotics: A Pharmacovigilance Study of the FDA Adverse Event Reporting System (FAERS)

“…The methods of data mining were previously used in other published FAERS studies [17][18][19]. FAERS data from January 1, 2004 to December 31, 2017 were included in the study.…”

“…Each antibiotic was identified in FAERS by generic and brand names listed in the Drugs@FDA Database [17][18][19][20]. Drugs with a reported role coded as "PS" (Primary Suspect Drug) were evaluated for inclusion.…”

Focus on Clozapine Withdrawal- and Misuse-Related Cases as Reported to the European Medicines Agency (EMA) Pharmacovigilance Database

“…Due to clozapine's effectiveness, there has been support for considering the molecule in limiting substance use in patients with schizophrenia [26], to achieve both a reduction in substance use [27,28] and an improvement in positive/negative schizophrenia symptoms [29]. Additionally, differently from other antipsychotics, such as quetiapine, which has showed in recent years to be a strong potential for misuse and abuse [30][31][32][33], the recreational use of clozapine has not been noted in the literature. Conversely, clozapine withdrawal is a phenomenon which has already been described, even at therapeutic dosages [9].…”

Kvetiapinmisbruk – myte eller realitet?

“…Rapporter fra flere land viser at bruken av kvetiapin øker, og at en betydelig del av forskrivningen skjer utenfor godkjent indikasjon («off label») (5)(6)(7)(8). Spørsmålet er hva dette er uttrykk for, og hvordan det bør vurderes.…”

“…En rapport bruker betegnelsen recreational abuse (5). Evoy og medarbeidere bruker termen abuse related events (7). Termene defineres imidlertid ikke med diagnostiske kriterier for ruslidelse, men bygger enten på bruk utenfor godkjent indikasjon eller på ulike kriterier for innleggelser på grunn av forgiftninger og andre kriser.…”