((A-241)) (A-241) Safety Reporting of Homeopathic Products: A Preliminary Investigation in the FDA Adverse Event Reporting System (FAERS) Data

Background: Homeopathic products are labeled as containing a wide range of substances that are highly diluted. Over the last decade, the homeopathic drug market has grown exponentially. Although regulated as drugs under the Food, Drug, and Cosmetic Act, homeopathic products marketed in the United States (U.S.) have not been evaluated for safety or effectiveness by the FDA.

Objectives: This preliminary, retrospective, descriptive analysis evaluated safety reporting of homeopathic products in the U.S. FDA FAERS data.

Methods: We analyzed the FDA’s FAERS data to identify reported adverse events (AEs) related to homeopathic products between 01/01/2004 and 09/30/2024. Verbatim search of any AE reports with drug names including “*homeopath*” were included, aiming to identify AE reports related to “homeopathy” or “homeopathic” products. Proportions of AE reports were examined by patient demographics (age and sex), type of reporter, and outcome of AEs (i.e., seriousness, death, and hospitalization). Annual frequency and proportion (among all AEs reported to the FAERS) of AEs related to homeopathic products were assessed. Data analysis was conducted using SAS (version 9.4).

Results: We identified a total of 1586 AE reports related to homeopathic products, ranging from 23 AEs in 2004 to 244 AEs in 2016. The annual proportion of AEs related to homeopathic products remained low and stable in 20 years, ranging from 0.003% in 2015 to 0.0021% in 2016 (0.011% in 2004 and 0.007% in 2024). Patient’s age was missing among 26.7% of homeopathic AEs, and 30.8% of AEs involved patients aged in 19-65 years, 23.5% in those less than 18 years old, and 19.0% among those older than 65. Most patients were female (59.3% vs. 34.4% male) and consumers (57.1% vs. 20.1% healthcare professionals) were the most frequent type of reporter for homeopathic AEs. A large proportion of these AEs were serious (79.4%), 20.6% involved hospitalization, and 3.1% led to death.

Conclusions: This preliminary study examined the frequency and characteristics of post-marketing safety reporting of homeopathic products in the FDA FAERS data. Given the sparse research in homeopathic products, findings of this study serve as a starting point for further investigation of searches based on a list of individual homeopathic products, active ingredients, and therapeutic areas. We acknowledge the limitations with FAERS data, such as under-reporting, missing data, lack of denominators, and lack of causality between suspected drug products and AEs. Findings of this study call for more research in post-marketing effectiveness and safety of homeopathic products.