Gabapentin drug misuse signals: A pharmacovigilance assessment using the FDA adverse event reporting system

Vickers‐Smith, Rachel; Sun, Jiangwen; Charnigo, Richard; Lofwall, Michelle R.; Walsh, Sharon; Havens, Jennifer R.

doi:10.1016/j.drugalcdep.2019.107709

Cited by 36 publications

(25 citation statements)

References 35 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…There are several pharmacovigilance studies describing the abuse and misuse of gabapentinoids (Table 1 ). Two recent US studies reported data from the US Food and Drug Administration adverse event reporting system [ 16 , 17 ], included pregabalin and gabapentin reports during the period 2012–16 [ 17 ] and 2005–12 [ 16 ]. Both studies, partly covering the same data, found a higher proportion of abuse-related reports for pregabalin (10.2% of 571 reports [ 17 ] and 26.1% of 97,813 reports [ 16 ]) compared with gabapentin (5.7% of 10,038 reports [ 17 ] and 22.9% of 99,977 reports [ 16 ]).…”

Section: Resultsmentioning

confidence: 99%

Current Evidence on Abuse and Misuse of Gabapentinoids

2020

View full text Add to dashboard Cite

This review summarizes current evidence on the abuse and misuse of the gabapentinoids pregabalin and gabapentin. Pharmacovigilance studies, register-based studies, surveys, clinical toxicology studies, and forensic toxicology studies were identified and scrutinized with the goal to define the problem, identify risk factors, and discuss possible methods to reduce the potential for abuse and misuse. Studies found that gabapentinoids are abused and misused and that individuals with a history of psychiatric disorders or substance use disorder seem to be at high risk. Moreover, some evidence supports the notion that patients with opioid use disorders may be at an increased risk of abusing gabapentinoids. Available evidence also suggests that abuse and misuse are more frequent in users of pregabalin compared with users of gabapentin. Health professionals and prescribers should be aware of the risk for misuse of pregabalin and gabapentin, which eventually could lead to abuse, substance dependence, and intoxications. Prescribing to patients belonging to risk populations such as those with psychiatric disorders or substance use disorder should be avoided if possible and, if prescribed, signs of misuse and abuse should be monitored.

show abstract

Section: Resultsmentioning

confidence: 99%

Current Evidence on Abuse and Misuse of Gabapentinoids

2020

View full text Add to dashboard Cite

show abstract

“…Although misuse was not formally reported in FAERS, AEs such as euphoric mood, dissociation and related symptoms (i.e., autoscopy, derealization, dissociative disorder, disorientation), feeling drunk, and hallucinations are in line with the esketamine potential for misuse and abuse, as they produce a desired mental state and perceptual changes [42,43], that were also found to occur immediately after administration. Similar effects have been previously described for gabapentin [42] and ketamine, which has become a popular recreational drug [44][45][46]. Likewise, the immediate time-to-onset (within 24 h) and the safety signal for esketamine-related euphoric mood, that has an estimated relative risk of 2.3 in one trial, goes in the direction of a high abuse potential [11].…”

Section: Discussionmentioning

confidence: 97%

Post-Marketing Safety Concerns with Esketamine: A Disproportionality Analysis of Spontaneous Reports Submitted to the FDA Adverse Event Reporting System

Gastaldon

Raschi

Kane

et al. 2020

Psychother Psychosom

View full text Add to dashboard Cite

Introduction: Esketamine nasal spray received approval for treatment-resistant depression in March 2019. Objective: Using the FDA Adverse Event Reporting System (FAERS) database (March 2019–March 2020), we analysed esketamine-related adverse events (AEs) to detect and characterize relevant safety signals. Methods: We used the consolidated case/non-case approach to estimate the reporting odds ratio (ROR) and information component (IC) with relevant confidence intervals (95% CI) for esketamine-related AEs with ≥4 counts. Comparisons between serious and non-serious AEs were performed using non-parametric tests. Results: The FAERS database contained 962 cases of esketamine-related AEs, with signals detected for several AEs, such as dissociation (ROR = 1,612.64, 95% CI = 1,354.63, 1,919.79; IC = 8.19, 95% CI = 7.96, 8.35), sedation (ROR = 238.46, 95% CI = 202.98, 280.15; IC = 7, 95% CI = 6.75, 7.18), feeling drunk (ROR = 96.17, 95% CI = 61.42, 150.57; IC = 4.84, 95% CI = 4.09, 5.36), suicidal ideation (ROR = 24.03, 95% CI = 18.72, 30.84; IC = 4.31, 95% CI = 3.9, 4.61), and completed suicide (ROR = 5.75, 95% CI = 3.18, 10.41; IC = 2.25, 95% CI = 1.23, 2.94). Signals for suicidal and self-injurious ideation, but not suicide attempt and completed suicide, remained when comparing esketamine to venlafaxine. Females and patients receiving antidepressant polypharmacy, co-medication with mood stabilizers, antipsychotics, benzodiazepines, or somatic medications were more likely to suffer from serious versus non-serious AEs (χ² = 125.29, p < 0.001, χ² = 9.08, p = 0.003, χ² = 8.14, p = 0.004, χ² = 19.48, p < 0.001, χ² = 25.62, p < 0.001, and χ² = 16.79, p < 0.001, respectively). Conclusions: Esketamine may carry a clear potential for serious AEs, which deserves urgent clarification by means of further prospective studies.

show abstract

“…Eine weitere Metaanalyse [ 5 ] konnte auf der Grundlage von 10 Studien einen moderaten Effekt auf die Symptome eines Alkoholentzugs und auf das Alkoholcraving nachweisen. Pharmacovigilance-Meldungen des FDA Adverse Events Reporting System finden Hinweise auf ein Missbrauchspotenzial der Substanz [ 103 ], das vermutlich auf den GABAergen Wirkmechanismus von Gabapentin und seine entspannenden Effekte zurückzuführen ist.…”

Section: Substanzenunclassified

Pharmakotherapie der Alkoholentwöhnung: Update und neue Entwicklungen

Soyka

Rösner

2020

Nervenarzt

View full text Add to dashboard Cite

Bislang sind nur wenige Medikamente zur pharmakologischen Rückfallprophylaxe der Alkoholabhängigkeit zugelassen. Neben dem in Deutschland nicht mehr vertriebenen Disulfiram sind es die Opioidantagonisten Naltrexon und Nalmefen sowie das vermutlich über glutamaterge Neurone wirkende Acamprosat. Baclofen und γ‑Hydroxybutyrat (GHB) sind in einzelnen Ländern zugelassen. Wirkstoffe wie z. B. Vareniclin, Gabapentin und Topiramat können für die Rückfallprophylaxe der Alkoholabhängigkeit von Interesse sein, jedoch ist bislang keine Zulassung erfolgt. Vor dem Hintergrund der zur Revision anstehenden S3-Leitlinie zur Diagnose und Behandlung alkoholbezogener Störungen wird der heutige Kenntnisstand zur Pharmakotherapie der Alkoholabhängigkeit dargestellt.

show abstract

Gabapentin drug misuse signals: A pharmacovigilance assessment using the FDA adverse event reporting system

Cited by 36 publications

References 35 publications

Current Evidence on Abuse and Misuse of Gabapentinoids

Current Evidence on Abuse and Misuse of Gabapentinoids

Post-Marketing Safety Concerns with Esketamine: A Disproportionality Analysis of Spontaneous Reports Submitted to the FDA Adverse Event Reporting System

Pharmakotherapie der Alkoholentwöhnung: Update und neue Entwicklungen

Contact Info

Product

Resources

About