A company called Standard Homeopathic Company is recalling all lots of its baby teething tablets after the Food and Drugs Administration found that the tablets had inconsistent levels of belladonna alkaloids.
According to the FDA, belladonna represents a serious health hazard to kids and its effects are unpredictable. The FDA told the company that there is no safe dose or toxic dose of belladonna in children, seeing as there are so many factors that can affect it.
Over 400 cases of adverse reactions to teething tablets have been reported
Standard Homeopathic Company stopped producing and shipping the product in October 2016, as the FDA has been investigating over 400 adverse events associated with the tablets in the last six years. The FDA recommends that if someone purchased the product they should throw it away or take it back to the store where it was purchased for a refund.
“We initiate this recall even after discontinuing production last fall because it is appropriate to do what our regulating agency has formally requested,” said J.P. Borneman, CEO of Standard Homeopathic Company, according to a statement published in the FDA website. “We are committed to maintaining and earning the trust consumers have placed in Standard Homeopathic Company.”
Borneman added that the company has been working for 114 years to build relationships with their customers and they intend to preserve that trust. The company notified distributors and retailers by mail and they are arranging for the return of all recalled products.
Belladonna is a plant that can be poisonous, which is normally used as a sedative and cold remedy. Some chemicals in the plant can block several functions of the central nervous system.
Belladonna can lead to convulsions and coma
According to the U.S. National Library of Medicine, the name belladonna means “beautiful lady”, and the name was chosen because of a practice involving the plant in Italy. In Italy, it was used to make a juice that allegedly helped women to enlarge their pupils, to give them a striking appearance. However, the plan is poisonous which caused adverse effects on women.
Although it’s marked unsafe it is used as a sedative, to stop bronchial spasms, and as a cold and fever remedy. Belladonna is also used to treat Parkinson’s disease, motion sickness, colic, and as a painkiller. It is also used rectally in hemorrhoid suppositories.
The U.S. National Library of Medicine explains how the plant has chemicals able to block some functions of the body’s nervous system. Some of the functions regulated by the nervous system include salivation, sweating, pupil size, digestive functions, and others.
They note that belladonna is likely unsafe when taken by mouth. Adverse reaction from consuming the plant can include dry mouth, enlarged pupils, blurred vision, fever, hallucinations, mental problems, convulsions, and coma.
Other belladonna-containing teething tablets have been recalled
The FDA had initially issued a safety alert in 2010 that recommended people not to use Hyland’s Teething Tablets after lab tests concluded that the tablets contained inconsistent amounts of belladonna.
Ever since they issued the alert, they received over 400 reports of adverse events linked to the use of teething tablets with belladonna. Some of the events included seizures, and the FDA noted that 10 deaths were reported during that period of time, which could be linked to homeopathic teething products. However, whether the tablets were solely responsible for the deaths is currently under investigation.
Hyland’s Teething Tablets was not the only teething product recalled by the FDA: in 2016 they recalled three belladonna-containing homeopathic products from Rarital Pharmaceuticals from East Brunswick, New Jersey.
Source: Washington Times