More than 400 teething babies given homeopathic remedies to help ease gum pain developed serious health problems over the past six years, including seizures, shortness of breath, vomiting, and constipation, according to an investigation by U.S. regulators. At least 10 died.
The Food and Drug Administration is warning parents and care providers about the potential dangers from the teething products, though its investigation isn't yet complete. The agency said it hasn't conclusively determined that homeopathic products were directly responsible for the deaths, and it didn't identify any of the brands.
Homeopathy is based on the notion that substances that cause symptoms of an illness can treat the malady when delivered in highly diluted doses. Developed in the 18th century, the practice is unsupported by medical science. Yet homeopathic and herbal products are sold alongside conventional medicines at chain drug stores, generating retail sales of $6.4 billion in the U.S. in 2012.
Already, increasing concern about teething products have limited their distribution. CVS Health Corp. pulled all brands from its pharmacies on Sept. 30, after the FDA recommended consumers stop using them.
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The warning stems from an examination conducted after the agency learned last month about a child who suffered a seizure after using a homeopathic teething product. Similar items were associated with a range of adverse events, including fever, lethargy, tremors, and irritability. Reports on the deaths all referenced homeopathic teething products, the FDA said.
"It is important to note that while adverse event reports give us some information about a product and serious injuries or deaths related to use of a particular product, they often indicate situations that require additional analysis and do not constitute conclusive evidence of a problem with the product," the agency said in an emailed statement. The number of reports can fluctuate as the regulator learns of additional cases, thanks to heightened awareness and elimination of duplicate reports.
The FDA first warned about the potential dangers of homeopathic remedies six years ago, when it alerted consumers about belladonna toxicity in Hyland's Teething Tablets. Belladonna is a poisonous plant, also known as deadly nightshade, whose roots and leaves are used to make a variety of medicines such as sedatives, cough suppressants, and pain killers. Hyland recently said on its website that it has discontinued selling homeopathic teething medicines in the U.S.