Another day, another recall of a children's product.
This week, Standard Homeopathic Company, the maker of Hyland's Teething Tablets, issued a voluntary recall for its teething aids after complaints of serious side effect in infants who consumed the pharmaceutical products. The product is a natural remedy for the side effects of teething, such as pain, restlessness and irritability.
According to the Hyland's website, the teething tablets are a "homeopathic combination of natural substances", one of which is belladonna, which comes from a poisonous plant known as deadly nightshade. Hyland's claims that the tablets contain only a trace amount of the alleged toxin, but the product was recalled when an FDA investigation uncovered a wide variance in the amount of belladonna in different packages of teething tablets.
The FDA began its investigation of the allegedly dangerous product after receiving complaints of "serious adverse events in children taking this product that are consistent with belladonna toxicity." Symptoms of such poisoning include depressed level of consciousness, skin flushing, constipation, lethargy, difficulty or slowed breathing, muscle weakness, or seizure.
After touring the Hyland's manufacturing facility, the FDA concluded that the company maintains "substandard control of the manufacturing operation" which inevitably leads to "varying amounts of belladonna" in its products.
Because the tablets are a natural remedy, they have not been approved by the FDA. However, the company has initiated a voluntary recall out of caution, and has plans to refine its production and testing protocols with the assistance of the FDA. However, in a recent news release Hyland's insisted that its products are safe.
"As a homeopathic product, Hyland's Teething Tablets have a wide margin of safety that protects consumers from harm," the company said. "After in-depth analysis, a comprehensive review of the company's adverse event report log, and more than 85 years of safe usage, the company is confident that Hyland's Teething Tablets are safe for infants and toddlers."
Source: WebMD, "Hyland's Teething Tablets Recalled for Poisoning Risk", Daniel J. DeNoon, 25 October 2010