On Homeopathic Products

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Last August an infant was rushed to the hospital after having prolonged seizures at home. She had no medical issues or allergies but had recently been given homeopathic teething tablets for the first time. The pills, which contained the poisonous plant belladonna, were the only medication she had taken. Luckily she survived but her father filed a MedWatch adverse event report with the U.S. Food and Drug Administration (FDA). That report triggered an FDA investigation, which found more than 400 reports of adverse events in infants and children associated with homeopathic products over the last six years. The events included seizures, tremors, fevers, shortness of breath, lethargy and sleepiness, constipation, vomiting, agitation, and irritability. Ten of the events resulted in the death of the child. On September 30 of last year, the FDA issued a warning to consumers that homeopathic teething products pose a significant risk to infants and children. The agency recommended that consumers stop using the products.

Following the FDA warning, CVS Pharmacy voluntarily removed all homeopathic teething products from its shelves. Less than two weeks later, Hyland’s, a popular purveyor of homeopathic teething products, discontinued its line of products in the USA. In late November, Raritan Pharmaceuticals issued a voluntary recall of three homeopathic teething and ear relief products for infants and children after the FDA found varying levels of belladonna in the products. In December the FDA press officer said, “The FDA is concerned about inconsistent amounts of belladonna, a potentially toxic ingredient if present in sufficient quantities, in homeopathic products.” Then in January the FDA announced that it found levels of belladonna in homeopathic teething products that “far exceeded” the amount stated on the label. The agency asked Standard Homeopathic Company, which makes Hyland’s products, to recall its teething products. The company refused. Unbelievably, the FDA does not have the authority to force a recall of dangerous products.

The research into homeopathic products is still ongoing. Many homeopathic products are supposed to be diluted before use in order to be safe for use on humans. Problems have arisen in the past when the products are not properly diluted. For example, in the teething products, the active ingredient is belladonna, also known as deadly nightshade. The active ingredient in belladonna is atropine, which can be fatal if taken at an improperly high dosage. Since 2009 the FDA has issued nearly 40 warnings to consumers regarding homeopathic products. In 2009 the FDA advised that consumers stop using zinc-containing cold remedies (i.e. Zicam) after it received more than 130 reports of loss of the sense of smell after using the products. In 2014 the FDA warned consumers to stop using Pleo Homeopathic products because they were found to contain penicillin and/or its derivatives, which could be life-threatening to penicillin-allergic individuals.

Just like dietary supplements, there is little to no credible research showing that homeopathic products actually work. Like most over-the-counter medications, homeopathic products are not regulated by the FDA and quality control in manufacturing the products may be lacking. So if you use these products be careful to dilute them as per the instructions and be aware that they may contain more or less of what the label says they contain.

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