Reports from the Food and Drug Administration obtained by STAT via a Freedom of Information Act request details the heartbreaking stories of babies and toddlers who became seriously ill or died after taking homeopathic teething products — which, as Ars has reported, the FDA has found to contain inconsistent amounts of toxic belladonna, also known as deadly nightshade.
The reports detail that more than 370 babies fell ill, with symptoms including muscle twitching, seizures, loss of consciousness and turning blue. The illnesses required emergency treatment and in some cases babies were airlifted to hospitals. Many of the symptoms are similar to belladonna poisoning, which is known to cause seizures, vomiting, difficulty breathing, lethargy, excessive drowsiness, muscle weakness, flushing of the skin, constipation, difficulty urinating, blurred vision, and confusion.
In response to warnings from the FDA last year, Hyland’s stopped distributing the products in the US. However, Hyland’s has continued to insist that the products are safe and has refused to recall them. They can still be found in some stores and online.
“My daughter had a seizure, lost consciousness, and stopped breathing about 30 minutes after I gave her three Hyland’s teething tablets,” read an FDA report. “She had to undergo mouth-to-mouth resuscitation to regain breathing and was taken to hospital.”
Another report included a handwritten note from a doctor to Hyland stating that his five-month-old patient was unresponsive for 45 minutes after taking the bite tablets. “I would like you to report this, to contact the FDA so that we can start an investigation and remove this dangerous, unregulated product from the shelves,” the doctor wrote.
One mother described how her child’s pupil dilated “like marbles.” Another reported that her daughter continued to have seizures after sitting at the tables. “I hate hate hate you for this,” she wrote to Hyland’s.
And then there were the obituaries. A grandmother told how her five-month-old grandson died in his sleep after taking the tablets. When he was found, his body was still 102 degrees Fahrenheit. The cause of death was ruled as acute cardiac arrest. “SOMEONE NEEDS INVESTIGATE THIS!!!!” she wrote.
In one incident in 2014, a nine-month-old girl died within 45 minutes of taking tablets for the first time. She was found in her crib next to a spatter of vomit. Her mother contacted Hyland months later after learning that the tablets could cause seizures. But by then she had thrown away her bottle of teething tablets and the company stated that further investigation was not possible.
The case shows how difficult it is to trace the source of such poisonings — and partly why it has taken so long for the FDA to issue warnings, which it did in 2010 and 2016.
The FDA does not review or approve homeopathic medicines and has little power to enforce a recall. However, the fact is confused by homeopathic manufacturers, who often offer false and baseless guarantees that their products are safe, effective and strictly regulated.
For example, in an undated press release from last year, Hyland’s stated, “Homeopathic medicines are regulated as medicines by the FDA.” They are not. In fact, Hyland’s homepage now has a little disclaimer that says, “The use of our products is based on traditional homeopathic practices. They have not been reviewed by the Food and Drug Administration.”
As STAT the Democratic Rep. Rosa DeLauro of Connecticut passed a bill last week called the Recall Unsafe Drugs Act that would give the FDA mandatory recall authority for homeopathic products and medications.
In a press release, DeLauro was quoted as saying:
Hyland’s refusal to recall its teething tablets, despite numerous health and safety warnings from the FDA, is nothing short of shameful. While the FDA has been urging consumers to stop using the products, Hyland’s is not going beyond what the law requires, choosing instead to prioritize the company’s profits and reputation over the safety of children. There is absolutely no reason why a potentially life-threatening product should be in our families’ homes, where unsuspecting parents can give it to their children.