Hylands Teething Tablets, Gels Removed from Market in U.S. After FDA Warning

Following recent warnings about the potentially serious risk of problems with homeopathic teething tablets and gels, Hylands has announced that it has pulled its line of treatments marketed for relief of symptoms associated with teething in children. 

Hyland’s announced it was suspending sales of Hyland’s Baby Teething Tablets and Baby Teething Gel in an announcement posted to its website on Tuesday, citing the recent FDA warning that indicated parents should not use homeopathic teething treatments, due to the serious side effects linked to the products.

While no Hylands teething tablets or gel recall was issued, the manufacturer indicates that it has chosen to discontinue distribution in the United States.

The FDA is currently investigating at least 10 deaths of children who used teething tablets or gel products, as well as 400 adverse events reported over the last six years, which they suspect are associated with homeopathic teething remedies. So far, the deaths and adverse events have not been proven to be connected to the teething products, but the safety of homeopathic teething treatments are under review.

Last week, the FDA called on parents not to use the homeopathic teething tablets or gels, due to the risk of serious side effects to babies, including fever, lethargy, vomiting, sleepiness, tremors, shortness of breath, irritability and agitation.

“It is therefore with much sadness that we share with you that we have chosen to discontinue the distribution of our Hyland’s teething medicines in the United States,” the Hyland’s letter to parents reads. “This decision was made in light of the recent warning issued by the Food & Drug Administration (FDA) against the use of homeopathic teething tablets and gels. This warning has created confusion among parents and limited access to the medicines.”

The products include:

• Hyland’s Baby Teething Tablets;
• Hyland’s Baby Teething Tablets Nighttime; and
• Hyland’s Baby Teething Gel

The manufacturer indicates that it has not received any adverse event reports that indicate the products were unsafe or posed an unreasonable risk of problems, Hyland’s teething products were pulled from the market to put customer safety first. In addition, many stores, such as CVS and Walgreens, have already pulled the products from story shelves due to concerns about potential risks with Hyland’s teething tablets and gels, as well as other homeopathic teething remedies.

In 2010, the FDA issued a recall for certain Hyland’s teething tablets products after the agency discovered the product contained varying levels of a key ingredient, belladonna. In large doses, belladonna can be toxic to humans. Some experts say the amounts used in homeopathic products can be effective, but must be carefully controlled. The agency was concerned unregulated amounts of the plant based ingredient could put a child at risk, especially if they were given more than was recommended.

Hyland’s reiterated that they are confident that all of their homeopathic products are safe for use, but prefer to work closely with the FDA and prevent further confusion concerning their products.

“Putting you in a position of having to choose who to trust in the face of contradictory information is burdensome and undermines the FDA,” the letter states. “We are committed to supporting you with quality homeopathic medicines as you tackle the incredibly challenging—and rewarding–role of raising your children.”

The manufacturer recommends that parents who have concerns should talk to their child’s doctor before using any medicines, read labels carefully and follow dosing instructions.

The American Academy of Pediatrics suggests alternatives for babies experiencing pain and discomfort from teething, including massaging the child’s gums with a clean finger, use a solid teething ring, clean wet washcloth chilled in the freezer, frozen bananas, or berries to soothe the child’s gums. The group also said parents can use an infant dose of acetaminophen, but should consult their doctor about the correct dose.