A pharma company has recalled kids' homeopathic ear relief liquid and teething tablets because the products contain varying levels of belladonna extract, which can be dangerous or fatal when consumed in large doses.
The recalled Raritan Pharmaceuticals products include CVS Homeopathic Infants' Teething Tablets, Kids Relief Homeopathic Ear Relief Oral Liquid and CVS Homeopathic Kids' Ear Relief Liquid, which are sold nationwide. The products, tested by the US Food and Drug Administration, were found to contain small but varying amounts of belladonna.
According to the FDA, the recall is precautionary. There have been no reports of the recalled products directly harming consumers.
"The recall is a precautionary action," said Sushant Pradhan, a Raritan Pharmaceuticals representative. He said the recalled products contain only about a nanogram of belladonna, which is "not toxic to anybody." However, the company has not received the recent belladonna test results from the FDA, according to Pradhan.
This fall, the FDA warned against using homeopathic teething tablets and gels after 10 deaths were reported. Though the causes of the deaths were not certain, the agency suggested that the homeopathic products contained potentially harmful amounts of belladonna, a toxin from a poisonous plant called deadly nightshade.
Typically, the homeopathic treatments contain just trace amounts of the toxin — a level that is supposed to be safe to consume.
However, belladonna poisoning can occur when too much is ingested. Seizures, difficulty breathing, lethargy and excessive sleepiness are symptoms of belladonna poisoning, according to the FDA.
When belladonna amounts are inconsistently labeled on treatments, the administration warned, children can be unknowingly exposed to dangerous doses.
After the FDA's warning was released, retailers such as CVS and Walgreens withdrew the suspect homeopathic teething tablets and gels from store shelves, though the products were not officially recalled before now.
Hyland's, a maker of homeopathic teething tablets and gels, discontinued distributing teething products in the US after the FDA warning. In a subsequent letter posted on its website, the company wrote, "We are confident that any available Hyland's teething products, including those you already have, are safe for use. Of course, parents who may have concerns should consult with their physicians before using any medicines, read labels carefully and follow all instructions."
Pradhan is similarly confident in the safety of Raritan's products.
"Belladonna can be toxic in high doses," Pradhan said. "But there are very trace amounts of (belladonna) in these products."
However, Pradhan acknowledged that there can be a wide range of belladonna levels across homeopathic treatments outside of the recalled products. Belladonna is used in several alternative medicines: it can be found in homeopathic eye drops and as a cure for upset stomach, he said.
"This is not your typical medicine," and homeopathic treatments should be used with caution, Pradhan said. People who use homeopathic treatments may be seeking a healthier, more natural remedy than with modern medicine, he explained, but alternative cures risk being less regulated than standard medications.
The FDA advises consumers of the recalled Raritan products to immediately stop using them. If any health problems occur when using these products, consumers should consult a physician or health care provider, the FDA says.
The FDA website offers a complete description of the recalled products and distribution information. Raritan Pharmaceuticals can address any further questions at 1-866-467-2748.