OBJECTIVES: The purpose of this study was to identify abuse-related post-marketing reports associated with gabapentinoids use in the Middle East and North Africa (MENA) region countries.

METHODS: A retrospective analysis of reports from the Middle East and North Africa (MENA) region was performed using the Food and Drug Administration Adverse Event Reporting System (FAERS) database from 2008 through May 2019. Abuse-related adverse drug event (ADE) reports for gabapentin and pregabalin were extracted from FAERS. Descriptive statistics were performed and the proportional reporting ratio (PRR) was calculated to detect a disproportional attribution of ADEs for gabapentin versus pregabalin.

RESULTS: We identified 477 all-cause ADE reports for gabapentinoids, including 164 (34.4%) abuse-related ADE reports reported to FAERS, from 2008 to May 2019. FAERS included 110 (67.1%) pregabalin and 54 (32.9%) gabapentin abuse-related ADE reports. Among MENA region countries, Turkey (35, 31.8%) and Saudi Arabia (33, 30.0%) had the highest number of abuse-related ADE reports for pregabalin. The majority of pregabalin abuse-related ADE reports involved adult male patients. The PRR of pregabalin versus gabapentin abuse-related ADE reports was 1.11, indicating that the number of abuse-related events was higher for pregabalin compared to gabapentin.

CONCLUSIONS: Over 160 cases of abuse-related gabapentinoids events were reported to FEARS from the MENA region in the study period. Further studies should assess risk factors and potential programs to reduce gabapentinoids abuse.