17April2014

Wednesday, December 01, 2010

FDA issues consumer safety alert - Hyland’s Teething Tablets

Written by  dan glaser
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The U.S. Food and Drug Administration is warning that Hyland’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. 

The recalled products were distributed widely in California to various retail chain stores, pharmacies and supermarkets including but not limited to: Target, Walgreens, Rite Aid, Wal-Mart, CVS, Safeway, Winco Foods, and Grocery Outlet. 

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 Hyland’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 Hyland’s Teething Tablets. 

Hyland’s Teething Tablets is an over-the-counter product intended to provide temporary relief of teething symptoms in children. The FDA has not evaluated Hyland’s Teething Tablets for safety or efficacy, and is not aware of any proven clinical benefit offered by the product.  

The FDA urges both health care professionals and consumers to report side effects from use of Hyland’s Teething Tablets to the FDA’s MedWatch Adverse Event Reporting program.  Consumer information is available at 888-INFO-FDA.                            


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