Lennihan Burke

Food and Drug Administration Action Against Homeopathic Teething Tablets Lacked Evidence Base

Alt Complem Ther, 2018, in press


A close examination of the incident reports to the Food and Drug Administration (FDA) regarding homeopathic teething tablets reveals a lack of evidence either for the FDA advisories regarding them or the media reports claiming that hundreds of infants were harmed soon after ingesting them. Many of the incident reports were requests for information from concerned parents, while the rest lacked a temporal association with ingestion or failed to rule out confounding medications or health conditions. The only other recent example of alleged harm from a homeopathic product was the case of Zicam®, withdrawn from the market after users reported loss of their sense of smell. Two views of Zicam are examined—that it was a supplement falsely labeled homeopathic or that it was an outlier among bona fide homeopathic medicines—neither of which would implicate the safety of homeopathic medicines in general. A recent New England Journal of Medicine perspectives piece is addressed: it calls for homeopathy to be regulated more stringently, as pharmaceuticals are. This article agrees that additional regulations and enforcement are needed. However, they should be limited to minor adjustments to make homeopathy more accessible to consumers and to minimize fraudulent products. This article asserts that homeopathy is already safer and can be more effective than pharmaceuticals, while current regulations of pharmaceuticals have failed to ensure their safety or effectiveness. The low risk–benefit ratio of homeopathy is asserted based on its minimal risk and its potential great benefit to consumers and the healthcare system as a whole, including cost savings, reducing antibiotic usage in humans and animals, and providing a rapid response to an epidemic. Finally, a proposed “new therapeutic order” is recommended in which safe holistic modalities such as homeopathy are used first, with drugs and surgery used only as a last resort.

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