Homeopathic teething tablets made and distributed by Raritan, CVS, Hyland’s, and others are intended to soothe teething babies and are classified as over-the-counter drugs. But such tablets have not been assessed or approved by the FDA for safety or efficacy, and after years of FDA Warnings and Alerts regarding inconsistent amounts of belladonna, these homeopathic teething products have finally been removed from the market.
The FDA is aware of at least 400 reports of seizures and other side effects as well as 10 deaths from belladonna poisoning which has led to teething tablet lawsuits filed against Standard Homeopathic, the manufacturer of Hylands Teething Products.
According to FDA lab testing into these homeopathic teething products, varying amounts of belladonna were found in the tablets and is likely the cause of injury to these children. Belladonna is a toxic and poisonous plant that has been used as a poison as well as an ingredient in homeopathic medicine for hundreds of years. But, belladonna has not been FDA approved and the FDA warns that children less than two years all may respond to belladonna in an unpredictable way.
Parents have reported belladonna toxicity resulting in dry mouth, enlarged pupils, blurred vision, red dry skin, fever, fast heartbeat, inability to urinate or sweat, hallucinations, spasms, mental problems, convulsions, seizures and coma. In 2017, the FDA warned consumers to seek medical attention if they observe any of these symptoms in children using homeopathic teething tablets.
The FDA Adverse Events website tells the story of a company hell bent on ignoring panicked parent’s pleas to discontinue a product that teams of doctors told them harmed their babies. Seven years of injuries and deaths reported and presented to a company that marketed this product to parents who believed this was the “natural choice” – Hyland’s homeopathic teething tablets.
Not only did Hylands continue to market this dangerous product despite knowledge of the injuries, they also took action to continue to deceive the public by telling them that their products were safe even at large doses and that anyone saying otherwise was promptly dealt with through phone calls and bans from the company’s social media pages.
On October 23, 2010, the FDA warned parents to stop using Hyland’s Teething Tablets because FDA lab testing found varying amounts of belladonna in the tablets. During 2010, Hylands was informed of four infant deaths that were consistent with belladonna toxicity. Some of these deaths were previously reported as SIDS. As a result, Hyland recalled their homeopathic teething tablets but they returned to the market in 2011 when the company stated that they had “identified manufacturing processes of teething tablets that can be improved to ensure uniformity in dosage.”
According to FDA documents, the belladonna poisoning did not stop after the reformulation. In 2012, the FDA shows the company was warned of several seizing infants, admittance to the ER and one known death. These events occurred after the reformulation.
Instead of taking action to discover why the belladonna poisoning continued, Hylands took to public relations, making sure that any parents vocally complaining or warning others were banned from the company’s social media pages.
FDA records from 2012 to the present day tell the sad story of seven years of belladonna poisoning that could have been prevented. Numerous children presented with symptoms such as seizures, difficulty breathing, lethargy, excessive sleepiness, and some ultimately became dehydrated and several ultimately died.
Studies estimate that injuries are reported to the FDA 10% of the time. Given the number of injuries that have been reported, we can only imagine how many other infants were continuously given toxic tablets by their family and how many suffered as a result.
Teething tablet lawsuits move forward on behalf of the many families who believe their homeopathic teething product may have been the cause of seizures and other injuries in their infants. We look forward to holding these companies responsible for these injuries.