Yesterday the FDA recommended that parents stop using Hyland’s Teething Tablets. The Standard Homeopathic Company also announced that it is voluntarily recalling its Hyland’s Teething Tablets based on the FDA’s concerns and to examine its manufacturing process.

Homeopathic Products

Homeopathy is quite different from traditional medicine. The National Center for Homeopathy describes homeopathy as:

Homeopathy is a system of medical therapy that uses very small doses of medicines, or remedies. These remedies are prepared from substances found in nature. Nevertheless, homeopathy should not be confused with herbal medicine. These two systems of medicine are very different. Herbal medicine uses tinctures of botanical substances, whereas homeopaths use ultradilute “micro”doses made from not only plants, but minerals or any other substance found in nature.

Homeopathic products, like Hyland’s Teething Tablets, are not reviewed by the FDA for safety or efficacy unless there are complaints about safety. Hyland’s Teething Tablets are very popular with parents and have a lot of anecdotal evidence of effectiveness, but don’t have any major clinical trials showing that they work or are safe. Natural Medicines Comprehensive Database, a highly respective resource used by physicians and pharmacists, rates Hyland’s Teething Tablets as a 5 (neither safe and effective or unsafe and ineffective) based on known studies.

Regarding this recall, The Standard Homeopathic Company states:

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.

“We initiated this voluntary recall to ensure our consumers know that their families’ safety and health are our top priorities,” said Mark Phillips, PharmD, President and Chief Pharmacist of Standard Homeopathic Company. “We are committed to maintaining and deserving the trust they have placed in Hyland’s. We have worked for 107 years to build relationships with our consumers. We intend to preserve that tradition of trust.”

Concerns over Belladonna

Because Hyland’s Teething Tablets are a homeopathic product, they contain very low levels of ingredients, including belladonna. Belladonna is a potentially toxic ingredient also known as deadly nightshade that can be used both as a poison and a medicine. The FDA is concerned that recently tested tablets have not contained a consistent amount of belladonna. Serious side effects have been reported to the FDA that may be a result of the belladonna and the FDA’s inspection of the manufacturing process has found substandard control procedures. Additionally, Hyland’s teething tablets do not come in child resistant packaging so there are some reports of children taking an “overdose” of tablets.

Symptoms of Belladonna Toxicity

Call your Peditrician if your child shows the following signs after taking Hyland’s Teething Tablets:

• depressed level of consciousness
• seizure
• difficulty or slowed breathing
• lethargy
• sleepiness
• muscle weakness
• skin flushing
• constipation
• difficulty urinating
• agitation

What to do with the Teething Tablets

All lots of Hyland’s Teething Tablets have been recalled and the FDA recommends that parents stop using all product immediately.

Consumers that are concerned about the safety of the product may contact Standard Homeopathic Company for instructions on a refund or replacement product. For these instructions or information regarding how to return or dispose of the product, consumers should log on to www.hylandsteething.com/recall or call 1-877-496-5044 (Monday-Friday 8 a.m. to 10 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time).