The Food and Drug Administration’s Safety Surveillance of Adverse Event Cases Involving Cannabinoid Hemp Products, 2019–2023

Bibliographic Data

ID11036833
AuthorsLisa Wolf (0000-0002-7372-6051, Lisa Wolf and Michelle Hines are with the Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD. Oliver Ou, Beverly Wolpert, Nichole Nolan, and Stephanie Kenez are with the Office of Analytics and Outreach, Center for Food Safety and Applied Nutrition, US Food and Drug Administration, College Park, MD. Cassandra Taylor is with the Office of the Center Director, Center for Drug Evaluation and...), Lisa Harinstein (Center for Drug Evaluation and Research), Michelle Hines (0009-0000-4389-8699, Lisa Wolf and Michelle Hines are with the Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD. Oliver Ou, Beverly Wolpert, Nichole Nolan, and Stephanie Kenez are with the Office of Analytics and Outreach, Center for Food Safety and Applied Nutrition, US Food and Drug Administration, College Park, MD. Cassandra Taylor is with the Office of the Center Director, Center for Drug Evaluation and...), Oliver Ou (0009-0005-9268-4757, Lisa Wolf and Michelle Hines are with the Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD. Oliver Ou, Beverly Wolpert, Nichole Nolan, and Stephanie Kenez are with the Office of Analytics and Outreach, Center for Food Safety and Applied Nutrition, US Food and Drug Administration, College Park, MD. Cassandra Taylor is with the Office of the Center Director, Center for Drug Evaluation and...), Beverly Wolpert (0000-0002-3083-7384, Lisa Wolf and Michelle Hines are with the Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD. Oliver Ou, Beverly Wolpert, Nichole Nolan, and Stephanie Kenez are with the Office of Analytics and Outreach, Center for Food Safety and Applied Nutrition, US Food and Drug Administration, College Park, MD. Cassandra Taylor is with the Office of the Center Director, Center for Drug Evaluation and...), Nichole Nolan (0009-0007-3896-8083, Lisa Wolf and Michelle Hines are with the Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD. Oliver Ou, Beverly Wolpert, Nichole Nolan, and Stephanie Kenez are with the Office of Analytics and Outreach, Center for Food Safety and Applied Nutrition, US Food and Drug Administration, College Park, MD. Cassandra Taylor is with the Office of the Center Director, Center for Drug Evaluation and...), Stephanie Kenez (0009-0003-7858-8676, Lisa Wolf and Michelle Hines are with the Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD. Oliver Ou, Beverly Wolpert, Nichole Nolan, and Stephanie Kenez are with the Office of Analytics and Outreach, Center for Food Safety and Applied Nutrition, US Food and Drug Administration, College Park, MD. Cassandra Taylor is with the Office of the Center Director, Center for Drug Evaluation and...), Cassandra Taylor (0000-0001-7476-2049, Lisa Wolf and Michelle Hines are with the Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD. Oliver Ou, Beverly Wolpert, Nichole Nolan, and Stephanie Kenez are with the Office of Analytics and Outreach, Center for Food Safety and Applied Nutrition, US Food and Drug Administration, College Park, MD. Cassandra Taylor is with the Office of the Center Director, Center for Drug Evaluation and...)
Year2024
Volume114
IssueS8
PagesS664-S672
Publication date2024-11-01
Peer ReviewedYes
Open AccessNo
TypeARTICLE
VenueAmerican Journal of Public Health (JOURNAL)
Journal identifiersISSN: 0090-0036 • E-ISSN: 1541-0048
PublisherAmerican Public Health Association (PUBLISHER • US)
DOI10.2105/ajph.2024.307712
OpenAlexW4403665853
LanguageEN
References cited11

Objective. To characterize adverse event (AE) cases received by the US Food and Drug Administration (FDA) reportedly involving cannabinoid hemp products (CHPs). Methods. We searched the FDA Adverse Event Reporting System and Center for Food Safety and Applied Nutrition Adverse Event Reporting System for cases reported directly to the FDA from 2019–2023 involving CHPs, which are defined as products containing 1 or more of the following: cannabidiol, delta-8 tetrahydrocannabinol, and emerging cannabinoids (i.e., other intoxicating cannabinoids often synthesized from hemp-derived cannabidiol). We abstracted and summarized information on reporting trends, consumer demographics, reporter information, product information, and AEs. Results. We identified 610 AE cases reportedly involving CHPs containing 1 or more of the following: delta-8 tetrahydrocannabinol (n=355), cannabidiol (n=253), and emerging cannabinoids (n=36). Multiple trends and safety issues were identified, including an annual increase in the number of cases involving intoxicating cannabinoids since 2021, potential quality issues, and the occurrence of fatalities and pediatric exposures. Conclusions. Our findings emphasize the importance of monitoring AE cases received by the FDA involving CHPs as part of a comprehensive surveillance strategy to identify trends and safety issues with these products. ( Am J Public Health. 2024;114(S8):S664–S672. https://doi.org/10.2105/AJPH.2024.307712 )

Administration (probate law) · Adverse effect · Adverse Event Reporting System · Cannabinoid · Cannabis · Drug · Drug administration · Environmental health · Food and drug administration · Political science · Psychiatry · Internal Medicine · Medicine · Pharmaceutical Economics and Policy · Pharmaceutical studies and practices · Pharmacology · Pharmacovigilance and Adverse Drug Reactions

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