Ensuring “Safety” Remains the Hallmark of Homeopathic OTCs

By Mark Land, M.S., RAC-US, AAHP President

Monitoring and reporting on the safety of homeopathic drug products is a multifaceted undertaking that begins in the product development stage. Homeopathic drug products are considered one of the safest categories of drug products for self-medication. That reputation has been earned over many decades of safe use among consumers and health care providers. Safety cannot be taken for granted, however, and must be built into the drug product and monitored during the life cycle of the product.

In this issue, Eric Foxman discusses HPUS’ calculation of the Lowest Permissible Attenuation (LPA). This is a beginning step. Establishing the LPA for each substance within the product formulation sets a baseline of safety for formulators to consider when developing a drug product. The same care must be taken with inactive ingredients. Are they safe and suitable for the intended use and according to the labeled directions. With this as a basis, formulators can be reasonably assured of the safety of their formulation. This is theoretical however, and therefore the safety of the product must be followed during marketing.

Also in this issue, Kristina Skowronek discusses the FDA Adverse Event Reporting System (FAERS). Since most homeopathic drug products marketed in the United States are sold over the counter (OTC), manufacturers are required to report only serious adverse events to FDA via FAERS. That means FAERS is not a full collection of all case reports, which limits our understanding of the full experiences with homeopathic drug products. Nevertheless, the database is helpful. FDA recently conducted research on Amazon consumer reviews as compared to the FAERS database and found that the frequency and type of case reports on Amazon reviews was similar to the FAERS database.¹

Maintaining a pharmacovigilance system to capture, report, and analyze adverse event reports is a regulatory requirement — as well as the only way to understand consumer experiences with your products.

Another facet of safety is learning lessons from others and applying those lessons to your products. An AAHP member generously shares his experience on nitrosamine. Robert Sven Jechlitschka discusses nitrosamine risks and available methods to detect it in active and inactive ingredients. Nitrosamine contamination has been a topic of discussion within the pharmaceutical industry for nearly a generation now. Early on it was considered a risk for only a small subset of active pharmaceutical ingredients. Today any substance containing nitrogen within its makeup is a potential nitrosamine donator and must be evaluated as a risk. This is true also for homeopathic ingredients, and manufacturers are required by regulations to include nitrosamine risk analysis within their development, manufacturing, and testing programs.

This is a small snapshot of safety related topics for homeopathic drug products. Thoughtful research on the safety of homeopathic drug products is necessary. Although much is being done to understand the safety of homeopathic drug products, the current literature base is quite limited. This causes regulatory authorities and others to rely on outdated reports or to speculate on the safety of this category. More research is necessary. AAHP is working on several projects in this area. Look for more information on the safety of homeopathic drug products from AAHP in the future.

References

1.  Konkel, K., Oner, N., Ahmed, A., Jones, S.C., Berner, E.S., Zengul, F.D. “Using Natural Language Processing to Characterize and Predict Homeopathic Product-Associated Adverse Events in Consumer Reviews: Comparison to Reports to FDA Adverse Event Reporting System (FAERS).” J Am Med Inform Assoc. 2023 Dec. 22; 31(1): 70–78. https://doi.org/10.1093/jamia/ocad197