The FDA has issued its first warnings against homeopathic medicines, and this is only the beginning. Action Alert! The FDA has sent warning letters to all of the companies in the US that sell injectable homeopathic medicine because, in the agency’s view, injectable homeopathic medicines “can pose a serious risk to patient health.” This is following a bad guidance
The FDA has issued its first warnings against homeopathic medicines, and this is only the beginning. Action Alert!
The FDA has sent warning letters to all of the companies in the US that sell injectable homeopathic medicine because, in the agency’s view, injectable homeopathic medicines “can pose a serious risk to patient health.” This is following a bad guidance the agency is in the process of completing that upends decades of safe regulation of homeopathic medicines. The FDA’s position on homeopathic injectables puts safe pain and cancer therapies in jeopardy. In our view, the FDA is using this initial attack as an entry point to eliminate homeopathic medicine entirely, and we cannot let it proceed unchecked.
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 (mercury), plumbum aceticum (lead), and snake venom. This is in line with the approach outlined in the FDA’s draft guidance which stipulates certain categories of homeopathic medicines that are targets for FDA enforcement actions. Recall, though, that the approach taken in this guidance gives the FDA free reign to go after all homeopathic drugs, which in our view is the agency’s endgame.
The FDA’s warning letters make clear that all injectable homeopathic medicines are in their crosshairs. This means that homeopathic mistletoe for injection is at risk, a safe cancer therapy that has been used for years. Studies show that mistletoe can improve symptoms and quality of life, and reduce chemotherapy and radiotherapy side effects, including in pancreatic, lung, colorectal, and breast cancers.
Is there really a safety issue with injectable homeopathic medicines that demands immediate FDA action? One of the products the FDA has targeted is Traumeel, a prescription-only homeopathic medicine for pain. According to the manufacturer, out of more than 200 million ampules sold, there have been 154 adverse reactions, including 7 serious adverse events. Traumeel is an alternative to opioids, which in 2017 alone killed 47,000 Americans. A randomized controlled trial found Traumeel to be effective in post-chemotherapy stomatitis (inflammation of the mouth and lips).
Other products show a similarly low rate of adverse events, especially compared with pharmaceutical drugs the FDA approves. A review of the evidence of adverse events related to homeopathy, which included data from 12 European countries, the US, Mexico, India, Israel and Brazil published between 1978 and 2010, found a total of just 1,159 adverse events. This equates to an average of just over 50 cases per annum across all 17 countries from which studies were conducted. By comparison, foodborne illness contributes to on average of 128,000 hospitalizations and 3,000 deaths annually in the US alone. Worldwide, an estimated 200 million people use homeopathy regularly, including 6 million in the United States. These data show that adverse events from homeopathic medicines occur at a very, very low rate.
Contrast this record of safety for homeopathic medicines with adverse events from FDA-approved drugs. From 1978 to 2010, there were more than 3.5 million serious adverse events and 571,398 deaths, according to the FDA’s database.
Regarding belladonna and nux vomica, which were 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. Note that any homeopathic substance is diluted, often extremely diluted. It would seem the FDA’s concern about toxicity is more theoretical than based in fact.
This is only the beginning of the FDA’s onslaught. As we’ve reported previously, the FDA considers all homeopathic medicines on the market to be “unapproved drugs.” The agency is trying to assert the legal right to go after any homeopathic treatment it chooses. Injectables are only the beginning. In our opinion, homeopathic drugs were intended to be grandfathered when the Food, Drug, and Cosmetic Act came into being, and this is being ignored by the agency.
The FDA has very serious questions to answer. Why are safer alternatives to dangerous opioids, like Traumeel and CBD, being systematically attacked by this agency? Why is the FDA focusing on homeopathic medicines that are far safer than the pharmaceutical drugs they approve—or even foods?
We can infer some answers. The FDA gets a large part of its funding from drug company user fees, and for this reason sees Big Pharma as its client. Homeopathic medicines, like supplements and other natural products, compete with pharmaceutical drugs, so the FDA uses its enormous power to tilt the scales in favor of the drug companies. And because natural products and homeopathic medicines generally cannot be patent-protected like drugs can, they can’t afford FDA-approval and so cannot make disease claims. It is one among many ways cronyism is undermining healthcare in this country.
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