FDA Warnings Against Homeopathic Medicines Part 1 of 2
A recent action alert from the Nevada Homeopathic Board says the FDA has sent warning letters to four companies that sell injectable homeopathic medicines, claiming that they “can pose a serious risk to patient health”. The FDA is in the process of completing an October 2019 draft of a “Guidance for FDA Staff and Industry” document on “Drug Products Labeled as Homeopathic” that upends decades of safe regulation of homeopathic medicines. In the Board’s opinion, this is the FDA’s entry point to eliminate homeopathic medicine entirely. The agency is trying to assert the legal right to go after any homeopathic treatment it chooses. Injectables are only the beginning.
The letters lay out two main reasons for FDA enforcement – the injectable route of administration and the presence of certain ingredients with “the potential for toxicity”, such as nux vomica, belladonna, mercurius solubilis, plumbum aceticum, and snake venom (note that any homeopathic substance is diluted, often extremely diluted). Regarding belladonna and nux vomica, two ingredients the FDA claims are “potentially toxic”: a search of the FDA’s adverse event database shows 82 adverse events from belladonna between 1986 and 2019. That averages to less than 3 adverse events a year. Nux vomica has one adverse event listed in the FDA’s database. It would seem the FDA’s concern about toxicity is more theoretical than based in fact.
A review of adverse events related to homeopathy published between 1978 and 2010, which included data from 17 countries, found a total of only 1,159 adverse events. This is an average of just over 50 cases per year. Contrast this record of safety with adverse events from FDA-approved drugs. According to the FDA’s own database, from 1978 to 2010, there were more than 3.5 million serious adverse events and 571,398 deaths! By comparison, foodborne illness contributes to an average of 128,000 hospitalizations and 3,000 deaths annually in the U. S. alone.
Terry Pfau DO, HMD