Attention Parents of Younger babies( ie teething age)

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

The U.S. Food and Drug Administration today is warning consumers that Hylandâ€[emoji]8482[/emoji]s Teething Tablets may pose a risk to children. The FDA recommends that consumers not use this product and dispose of any in their possession. The manufacturer is issuing a recall of this product.

Hyland's Teething Tablets are manufactured to contain a small amount of belladonna, a substance that can cause serious harm at larger doses. For such a product, it is important that the amount of belladonna be carefully controlled. FDA laboratory analysis, however, has found that Hylandâ€[emoji]8482[/emoji]s Teething Tablets contain inconsistent amounts of belladonna. In addition, the FDA has received reports of serious adverse events in children taking this product that are consistent with belladonna toxicity. The FDA has also received reports of children who consumed more tablets than recommended, because the containers do not have child resistant caps.

The FDA advises consumers to consult their health care professional if their child experiences symptoms such as seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using Hylandâ€[emoji]8482[/emoji]s Teething Tablets.

Hylandâ€[emoji]8482[/emoji]s Teething Tablets is a homeopathic product intended to provide temporary relief of teething symptoms in children that is sold over-the-counter (OTC) in retail outlets. The FDA has not evaluated Hylandâ€[emoji]8482[/emoji]s Teething Tablets for safety or efficacy, and is not aware of any proven clinical benefit offered by the product.

For more information, please visit: Hyland's Teething Tablets

http://www.fda.gov/NewsEvents/Newsro.../ucm230761.htm

Thank you for passing this along. I will let my friend know.

I just checked, and they are carried by Babies R Us, at least online.

Yes, these are widely available ... All three grocerys in town have them...

I just read about these on the baby boards I go on. They've been hotly debated on my board for, oh the last 10 months (so since our babies were born ), for just this reason. And I just gave my baby 2 before seeing the post tonight.

From what I gathered there, the greatest danger is in taking too many. But there are other brands that also contain the belladona, but are harder to od on. I've only given them to LO a handful of times; and they do help. But a friend of mine said the longer she used them the less they helped; so we try not to. I wonder if the other brands have been checked as well? I'd love to be able to use something like this since I know they do help!

Even baby orajel has adverse side effects I'm told. But then anything you take has the potential for a side effect. Good time for my LO to cut 4 teeth huh?

http://www.fda.gov/Safety/Recalls/ucm230769.htm

Working with FDA, Standard Homeopathic Company Voluntarily Recalls Hyland’s Teething Tablets to Address Manufacturing Process



Contact:
Mary C. Borneman
424-224-4135



FOR IMMEDIATE RELEASELos Angeles, October 23, 2010 - Standard Homeopathic Company, in consultation with the U.S. Food and Drug Administration (FDA), is voluntarily recalling its Hyland's Teething Tablets. The company is initiating this recall in an abundance of caution due to an FDA investigation of its manufacturing facility. Hyland’s Teething Tablets are manufactured in the United States and distributed throughout North America.

The Hyland’s Teething Tablets UPC codes included in the recall are:

1. Hyland’s Teething Tablets, 125 tablets, UPC # 3 54973 75041
2. Hyland’s Teething Tablets, 250 tablets, UPC # 3 54973 75042
3. Hyland’s Teething Tablets, 125 tablets, UPC # 3 54973 75066
4. Hyland’s Teething Tablets, 50 tablets, UPC # 3 54973 75044
5. Hyland’s Teething Tablets, 145 tablets, UPC # 3 54973 75121
6. Hyland’s Teething Tablets, Clip Strip 6x125 tablets, UPC # 3 54973 35109

Adverse events have been reported but the FDA has said that a conclusive link to Teething Tablets has not been determined. The company, in working with the FDA, has identified manufacturing processes of Teething Tablets that can be improved to ensure uniformity in dosage. As a homeopathic product, Hyland’s Teething Tablets have a wide margin of safety that protects consumers from harm.

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.

In addition to the product recall, Standard Homeopathic Company is refining its production, packaging and testing protocols. Throughout the process, Standard Homeopathic Company will continue to closely monitor and evaluate the situation and consult with FDA.

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/recall9 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).

"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."

Hyland's Teething Tablets is a homeopathic product intended to provide temporary relief of teething symptoms in children that is sold over-the-counter (OTC) in retail outlets.

Consumers who have medical concerns or questions should contact their healthcare provider. Any adverse reactions may also be reported to the FDA's MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch10.

With over 100 years of experience in providing families with access to safe, natural, reliable medicines, Standard Homeopathic Company and its division, Hyland’s, Inc., have many symptom fighting products consumers have come to trust. For more information on their line of products, visit www.hylands.com11 or www.facebook.com/Hylands.Health.

About Standard Homeopathic Company
Standard Homeopathic Company develops and manufacturers lines of homeopathic medicines, including its top-selling Hyland's brand. Hyland’s homeopathic formulas are manufactured with the highest quality natural ingredients following the strictest standards of preparation. With over a century of commitment, Standard Homeopathic Company’s tradition of excellence consistently provides quality and integrity in every product. From Hyland’s Teething Tablets to Hyland’s Calms FortÃ[emoji]169[/emoji], Standard Homeopathic Company cares for your family at every stage of life. Consumers can trust Standard Homeopathic Company’s products to be natural, gentle, effective and safe for the entire family