UPDATED: More Than 300 Children Were Harmed By Hyland's Homeopathic Teething Tablets
Update, 2/23/2017: The controversy surrounding Hyland's homeopathic teething products, formulated with diluted doses of belladonna, has reached a peak.
After the FDA issued a warning back in September 2016, Hyland's decided to cease distribution of the tablets in the United States - but refused to implement a recall, which would advise customers to stop using the products they already have.
The company addressed their customers in a letter last year, claiming that, despite the discontinuation - which is reportedly permanent - "any available Hyland's teething products, including those you already have, are safe for use."
Sadly, that hasn't been the case for multiple parents across the country - numerous seizures and infant deaths have continued to be reported to the FDA. According to a review of FDA records obtained by STAT News News, a startling 370 cases have been filed against the product (between 2006 and 2016), which, like many other "natural" products, do not require FDA approval for market sale.
On January 27, 2017, the FDA released another advisory, stating that the homeopathic tablets - homeopathy involves diluting a toxic ingredient so that it eventually may treat the symptoms it causes at higher doses - had inconsistent levels of belladonna that often exceeded the amount on the label. Since Hyland's has refused to issue a recall, the FDA recommends tossing out any tablets you may still have at home immediately.
The controversy now, however, resides in what some parents, physicians and politicians believe is the failure of the FDA to address Hyland's tablet's toxicity in a timely manner. Pointing the finger at the FDA, though, isn't necessarily accurate. "As it stands the FDA would have to go through an arduous legal process to take action against manufacturers such as Hyland's," Connecticut Democratic Representative Rosa DeLauro said in a press release. "This is unacceptable and threatens the health and safety of American families.''
Those arduous legal processes take time - time that American families, who have allegedly lost children to these teething tablets during the FDA's slow review period, will never get back.
It sounds like new policies, ones that focus on giving the FDA better and faster control over products that don't require FDA approval for sale, are in the works. DeLauro introduced the Recall Unsafe Drugs Act last week, which would give the FDA mandatory recall authority over homeopathic products and drugs.
"[The FDA doesn't] have a mechanism to say, 'this ingredient is unsafe, nobody should sell it,'" Sarah Sorscher, an attorney for the nonprofit Public Citizen Health Research Group said. "It might be time for Congress to give FDA a standard and say, you can issue a regulation saying no one can make it anymore."
[h/t STAT News]
Original, 10/4/2016: The teething phase is terrible for everyone involved, and desperate parents may jump at anything to soothe a child's pain. But be careful: If you've been using homeopathic chewing products, including tablets and gels sold by Hyland's or CVS, there could be a risk. After reports of infant seizures, the FDA released a Sept. 30 advisory warning parents to avoid these remedies.
FDA warns homeopathic teething tablets & gels may pose a risk to infants & children. Recommend stop use & dispose. https://t.co/fR4x2fWENR pic.twitter.com/neabzChAmg
- U.S. FDA (@US_FDA) September 30, 2016
"Consumers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething tablets or gels," the FDA said in its statement.
Homeopathy is an alternative medical practice that operates on a "like cures like" model, meaning that a small, diluted dose of a toxic substance becomes a cure for the symptoms it could cause at a higher dose. While homeopathic teething tablets are available at most drugstores, they are made with "natural" compounds that aren't regulated by the FDA.
This isn't the first time the FDA has taken issue with homeopathy. In 2010, they issued a safety alert for homeopathic teething tablets containing belladonna, meant to soothe redness and inflammation but can be deadly if consumed at high levels. The FDA maintains that there is no health benefit to using the ingredient.
Hyland's Homeopathic has issued a response to the most recent FDA advisory on its website: "There is no current recall of Hyland's Baby Teething Tablets ... Hyland's Baby Teething Tablets have safely treated the pain associated with teething for more than 85 years. There is NO scientific link between homeopathically-prepared belladonna, or Hyland's Baby Teething Tablets, and seizures."
So, what should you do instead? "Teething can be managed without prescription or over-the-counter remedies," says Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. The American Academy of Pediatrics (AAP) recommends one of the following cold items, as the cold acts as an anesthetic for gums:
Pacifiers
Spoons
Clean wet washcloths
Frozen bagels or bananas
Refrigerated teething rings
[h/t from Live Science]
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