FDA Warns Drug Maker Over Deadly Homeopathic Teething Tablets
The U.S. Food and Drug Administration (FDA) has issued a warning letter to a New Jersey based company, which recently recalled homeopathic teething tablets for infants and toddlers with inconsistent levels of belladonna, a toxic herb. According to a report in the Daily Hornet, the FDA sent Raritan Pharmaceuticals a warning letter on June 20, 2017 for manufacturing violations involving homeopathic teething tablets containing belladonna, which have been responsible for several child deaths.
Even though it is widely regarded as unsafe, belladonna is used as a sedative, to stop bronchial spasms in asthma and whooping cough, and as a cold and hay fever remedy. It is also used for Parkinson’s disease, colic, motion sickness, and as a painkiller. Side effects may include dry mouth, enlarged pupils, blurred vision, red dry skin, fever, fast heartbeat, inability to urinate or sweat, hallucinations, spasms, mental problems, convulsions, and coma.
Tablets Caused Seizures and Deaths
Raritan Pharmaceuticals has been accused of failing to test the quality of its ingredients and failing to implement manufacturing processes that would ensure a consistent level of belladonna in their teething tablets. The letter was issued in connection with a massive recall of the teething tablets that were laced with belladonna.
After testing the products, the FDA found that some of the tablets contained higher levels of belladonna than others. This inconsistency exposes infants and children who are given these drugs to potentially catastrophic side effects, the FDA said in its letter to the company. Raritan has agreed to stop manufacturing the teething tablets, which have been linked to several reports of babies suffering seizures and other symptoms that are consistent with belladonna poisoning.
The FDA also told the company that it failed to properly look into complaints from parents saying that their babies suffered seizures or other side effects after using the teething tablets. Since the FDA warned about the risks of belladonna teething tablets in 2010, more than 400 injuries and 10 infant deaths have been reported.
Product Liability Issues
Product manufacturers have a responsibility to ensure that anything they put out in the market is tested and safe for use by consumers. Anyone who is affected by a dangerous or defective product can seek compensation for his or her injuries, damages and losses by filing a product liability claim. It is unconscionable that this company chose to sell products to babies without properly testing them, putting young children in harm’s way. We hope they are held accountable for their reckless disregard and for clearly putting profits over the well-being of young children.