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Adverse events of epidiolex: A real-world drug safety surveillance study based on the FDA adverse event reporting system (FAERS) database

On June 25, 2018, the FDA granted approval to Epidiolex oral solution, marking it as the first cannabis-derived medication with a highly pure active ingredient to receive such recognition. In order to gain insight into the safety of Epidiolex in real-world clinical practice, Zhou et al (2023) conducted a study utilizing the FDA's Adverse Event Reporting System (FAERS) database to examine the adverse drug events associated with Epidiolex. This study encompassed adverse event reporting data from the third quarter of 2018 to the first quarter of 2023, comprising a total of 13,275 case reports linked to Epidiolex. The reports were submitted by consumers, doctors, and pharmacists.

The research revealed a correlation between adverse drug events and the timing of medication administration. Out of the 13,275 case reports, 630 cases reported adverse drug events occurring within 0-7 days after taking the medication, 275 cases within 7-28 days, 263 cases within 8-60 days, and 1285 cases after more than 60 days. Analysis of the FAERS databases identified several commonly known adverse drug events, such as atonic seizures, seizures, high-pitched crying, and abnormal weight. Additionally, the study uncovered previously unreported adverse drug events, including seizure clusters (81 case reports), a decrease in blood ketone bodies (3 case reports), cortical visual impairment (3 case reports), poverty of speech (9 case reports), and hyperactive pharyngeal reflex (3 case reports).

Zhou et al provide some insights into the potential reasons behind these adverse drug events. They propose that the CBD present in Epidiolex may interact with receptors and networks in the brain that are involved in the generation and spread of seizures, potentially leading to seizure clusters. Furthermore, Epidiolex may alter the concentration of anti-epilepsy drugs in some individuals, thereby impacting seizure control and potentially triggering seizure clusters. It is also plausible that certain individuals may experience seizure clusters after using Epidiolex due to genetic factors or physiological conditions. Epidiolex has the potential to impact fat metabolism, leading to a decrease in blood ketone bodies. Additionally, it can influence the functioning of the nervous system, particularly neural signalling in the cortical area of the brain, the pharyngeal reflex, and the language centre. These effects may give rise to adverse drug events such as cortical visual impairment, hyperactive pharyngeal reflex, and poverty of speech.

The findings of this study provide important insights into the potential risks associated with Epidiolex. It highlights the need for doctors to be cautious and attentive to any signs of similar symptoms in patients who are prescribed this medication. By closely monitoring for adverse events, healthcare professionals can better assess the balance between the benefits and risks of using Epidiolex. Additionally, conducting further research to understand the underlying causes of the adverse effects mentioned in this study would be beneficial for future medical advancements.



Zhou, Q., Du, Z., Qu, K., Shen, Y., Jiang, Y., Zhu, H., & Zhang, X. (2023). Adverse events of epidiolex: a real-world drug safety surveillance study based on the FDA adverse event reporting system (FAERS) database. Asian Journal of Psychiatry90, 103828.

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