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Hylands teething tablet lawsuits

Updated January 27, 2017

Hylands Teething Tablets FDA Warning!

FDA WARNING UPDATE

AUDIENCE: Consumer ISSUE: FDA announced that its laboratory analysis found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label. The agency is warning consumers that homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children and urges consumers not to use these products.

In light of these findings, the FDA contacted Standard Homeopathic Company in Los Angeles, the manufacturer of Hyland’s homeopathic teething products, regarding a recall of its homeopathic teething tablet products labeled as containing belladonna, in order to protect consumers from inconsistent levels of belladonna. At this time, the company has not agreed to conduct a recall.

BACKGROUND: Homeopathic teething products have not been evaluated or approved by the FDA for safety or effectiveness. The agency is unaware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children. In September 2016, the FDA warned against the use of these products after receiving adverse event reports.

In November 2016, Raritan Pharmaceuticals (East Brunswick, New Jersey) recalled three belladonna-containing homeopathic products, two of which were marketed by CVS.

RECOMMENDATION: The FDA recommends that consumers stop using these products marketed by Hyland’s immediately, and dispose of any in their possession.

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 products. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: • Complete and submit the report Online: www.fda.gov/MedWatch/report • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Hylands Teething Tablets Information

Hyland’s Teething Tablets is a homeopathic product, intended to provide temporary relief of teething symptoms in children. It is sold over-the-counter in retail outlets.

In October 2010, the FDA warned consumers to stop using and discard Hyland’s Teething Tablets. FDA analysis and testing identified Hyland’s Teething Tablets that contained varying amounts of belladonna, a potentially toxic ingredient. FDA received reports of serious adverse events in children taking this product that are consistent with belladonna toxicity. An FDA inspection at the manufacturer found substandard control of the manufacturing operation.

The manufacturer insists a baby would have to take a massive overdose to experience side effects, but this is only true if the product actually contains an extremely small amount of belladonna. The FDA found inconsistent amounts.

The FDA has also received reports of children who consumed more tablets than recommended, because the containers did not have child resistant caps. Hyland’s came in cardboard boxes and squeeze-tubes that could easily be opened by a child.

The products were recalled and “re-formulated,” but returned to the consumer market in 2011.

Hyland’s Homeopathic Teething Tablets & Gels for babies are now linked to 10 deaths and around 400 reports of seizures, fevers, and other symptoms of toxicity, according to FDA.

The FDA re-opened its investigation on September 9, 2016, and issued a new warning on September 30, 2016.

In October 2016, Hyland’s announced that it would discontinue the following products:
• Baby Orajel Naturals Gel and Tablets for Teething Pain
• Baby Orajel Naturals Gel for Teething Pain Nighttime Formula
• CVS Homeopathic Infant’s Teething Tablet and Liquid
• Hyland’s Baby Nighttime Teething Tablets
• Hyland’s Baby Teething Gel and Tablets

As well, the FDA recommends that consumers not use this product and dispose of any in their possession. 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.

You should talk to your pediatrician about how to soothe sore gums in a teething baby. TheLawFirm.com suggests the following:

Under supervision, give the baby something hard to chew on. A special teething ring is an option but a crust of bread, breadstick or a peeled carrot may work as well. Teething rings can be cooled in the fridge, but should not be frozen. Even if baby keeps dropping them, teething rings should not be tied around a baby's neck. A wet cold flannel may be as effective. Don't dip teething rings in anything sugary.

A cool sugar-free drink can help to soothe a baby's gums. Water is best.

Try to distract a fussy, teething baby by playing.

Age-appropriate baby pain relief may help teething pain.

Gums may feel better when gentle pressure is placed on them. Try massaging the baby's gums with a clean finger.

It is important that you do not give your baby topical anesthetic gels like Benzocaine or Lidocaine as these products can cause a deadly reaction called .

If you used Hyland’s and your child suffered a serious side effect, call TheLawFirm.com for a free consultation.

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