Exploring the Comparison of Cannabis and Psilocybin Adverse Events in a National Reporting System
In recent years, the legalization of cannabis and the consideration of psychedelics for medical use have sparked significant interest and debate. Understanding the real-world health risks associated with these substances is crucial for informed decision-making and public health safety. In a recent research poster titled "Comparison of Cannabis and Psilocybin Adverse Events in a National Reporting System," my colleagues and I delve into the prevalence and nature of adverse events reported for cannabis and psilocybin.
Background
As jurisdictions in the United States continue to legalize cannabis, there is growing interest in the potential medical applications of psychedelics, such as psilocybin-containing mushrooms. While both cannabis and psychedelics are increasingly discussed for their therapeutic potential, their health risks under real-world conditions remain a critical area of study.
The Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) provides a valuable tool for monitoring the safety of substances post-approval. However, products classified as Schedule 1 drugs, which include psychedelics and cannabis, are often underreported despite their potential risks.
Objective
Given the rising interest in these products and real-world evidence suggesting concomitant use, we aimed to explore the prevalence of adverse events related to cannabis and psilocybin reported in a national database.
Methods
We accessed the FAERS database, which supports the FDA's post-marketing safety surveillance. The search focused on substances such as psilocybin, cannabis sativa, and synthetic THC (11-Nor-9-carboxy-delta-9 THC). Key data points included demographics, calendar year, system organ class, and type of adverse reactions reported.
Results
The analysis compared the number of cases and common adverse events for psychedelics (LSD, psilocybin, mescaline) with those for widely used substances like cannabis flower, nicotine, and alcohol. Here are some highlights:
Estimated Users per Year:
Hallucinogens: 7.1 million
Cannabis (past year): 49.6 million
Nicotine (past month): 57 million
Alcohol (past year): 139 million
Common Adverse Events:
Psilocybin: Emotional poverty (2 cases), Overdose (6), Drug abuse (81)
Cannabis Flower: Overdose (839), Nausea (72), Hyperhidrosis (8)
Nicotine: Overdose (839), Drug dependence (214), Nausea (112)
Alcohol: Overdose (222), Emotional poverty (31), Drug abuse (39)
Conclusions
Our findings underscore the need for a robust system to track adverse events from psychedelics and cannabis. This real-world data is essential for guiding public health decisions and regulatory frameworks. While FAERS data is useful for signal detection, it often lacks comprehensive details, making it challenging to fully understand the scope of abuse and dependence.
To address this gap, we developed an adverse event tool designed to collect information specifically on hemp, cannabis, and psychedelics. This tool aims to provide a more nuanced understanding of these substances' safety profiles, ultimately supporting more informed public health strategies.
Strengths and Limitations
The study highlights several strengths and limitations:
Strengths: The FAERS database allows for the collection of data on any marketed product and uses minimal data points for reporting.
Limitations: The data may not fully represent the risk profile due to reporting biases, and only severe cases tend to be reported. Multiple drugs can be listed for a single adverse event, which can complicate the data interpretation.
How You Can Participate
The poster includes a QR code for those interested in anonymously reporting adverse events related to the use of cannabis and psychedelics. This effort is part of a broader initiative to enhance the availability of real-world data and improve the safety and efficacy of these products.
Final Thoughts
As the landscape of cannabis and psychedelic use evolves, ongoing research and data collection are paramount. Studies like this one provide critical insights into the real-world implications of these substances, helping to shape future policies and public health recommendations.
Stay informed and contribute to the growing body of knowledge by participating in reporting systems and staying engaged with the latest research.
Reference: Marcu, J., Simon, T. A., Simon, J., Wabwire, M., & Gomez, A. (2023). P3-53 Comparison of Cannabis and Psilocybin Adverse Events in a National Reporting System. Poster presented at ICRS 2023, Galway, Ireland.
