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Teething TabletsHomeopathic Teething Products Not FDA-Approved

Teething Tablets

 

In 2010, four innocent babies’ deaths were reported to Hyland’s. It was an early warning sign to the company that there was a serious safety issue with the Hyland’s teething tablets that should not be ignored. Yet, more tragic stories of teething tablet injury would soon follow and Hyland’s ignored all of them.

 

Hyland’s teething tablets initial recall

In 2010, the FDA received multiple reports of serious teething tablet injuries that were consistent with belladonna toxicity. The FDA tested the teething tablets and found the products to contain varying amounts of belladonna, a natural yet highly toxic ingredient. The FDA found Hyland’s had substandard control of their manufacturing operation.

On October 23, 2010, following their investigation, the FDA released a public warning urging parents to stop using Hyland’s teething tablets.

Hyland’s agreed to issue a soft recall of all teething tablets. The company promised the teething tablet line would continue to be manufactured with greater emphasis on supervision over belladonna levels.

Hyland’s claimed they had “identified manufacturing processes of teething tablets that can be improved to ensure uniformity in dosage.”

Soon after the recall, the company and the FDA received the first notifications of deaths that were suspected to be caused by Hyland’s teething tablets.

  • November 2, 2010 – The company was informed that an infant had died from seizures. The doctor attributed it to Sudden Infant Death Syndrome (SIDS).
  • December 2, 2010 – The company was informed that an infant  died after taking the Hyland’s teething tablets.
  • December 9, 2010 – The company was informed that an infant had died after taking Hyland’s teething tablets. The infant demonstrated symptoms that were consistent with belladonna toxicity.
  • December 16, 2010 – The company was informed that an infant had died after taking Hyland’s teething tablets.

These initial notices of death should have been a major warning sign to the company that there was a serious safety issue with Hyland’s teething tablets – an issue that could not be ignored.

Hyland’s ignored the issue and continued to put kids in harm’s way, even after they again started receiving reports of serious injuries.

In 2011, Hyland’s began marketing teething tablets, claiming that they had fixed the manufacturing issues. Hyland’s told parents the tablets were safe.

Injuries and deaths soon followed and it is inexplicable that Hyland’s ignored these clear alerts that their products were not safe.

 

Teething Tablet Injury Reports: Clear Warning Signs After the 2011 Reformulation

In February 2012, a parent posted on Hyland’s teething tablets web page that 30 minutes after taking the teething tablets, their son suffered a seizure and had to be taken to the ER. The parent posted, “WARNING TO PARENTS: belladonna, an ingredient in these tablets, is poison!!” An email was circulated around Hyland’s, including to CEO Jay Borneman, about the internet post. It’s unclear from public documents how the company ultimately responded, but they clearly did not warn parents or pull the product.

In October 2012, a detective received a call from a hospital to inform the detective that a baby had died while taking teething tablets. The tablets were manufactured on December 11, 2011, which was after the recall. A Hyland’s employee told the detective the belladonna was safe in this reformulated product.

In December 2012, the company received a report that an infant had been admitted to a hospital with an extreme fever, paleness, lethargy, and dehydration. The baby had to be flown to another hospital. The physician treating the child believed that these were “symptoms secondary to belladonna.” According to Hyland’s Consumer Complaint Record, the “doctor team said the child had a reaction to the belladonna.” A company representative contacted the mother after the mother attempted to post negative comments online – It appears based on public documents that Hyland’s blocked her posts.

The mother wanted to know “Why [does Hyland’s] continue to put belladonna in tablets?” The company had the audacity to tell the mom that it would be necessary to eat 800 tablets for the first symptoms of belladonna toxicity to occur. This is even after a team of doctors told her the belladonna caused her child’s injuries. The company offered her a refund. This callous disregard for the mother’s feelings and doctors’ assessment is so infuriating that it is difficult to put into words. The company was more worried about blocking her online comments than protecting the families still using their products.

These injuries, soon after the teething tablets were put back on the market in 2011, should have sent a clear warning to the executives at Hyland’s. I wish I could tell the story of every family found in the FDA records. There continued to be injuries and deaths in 2103, 2014, 2015, and 2016. To-date, there are at least 10 deaths and more than 400 seizures that have been directly reported to Hyland’s. It is heartbreaking and alarming to look through the reports of teething tablet injury. Parents were calling the company and literally begging, pleading, and screaming for the company to take action – to pull the product or warn parents of the dangers. Instead, despite every warning the company received, parents received none, and we are left with an untold number of seriously injured children.

 

FDA Issues Secondary Recall

In September 2016, as a result of the high frequency of teething tablet injury reports, the FDA issued a secondary warning urging parents and caregivers not to use Hyland’s teething tablets. In the warning the FDA explained that, “Homeopathic teething tablets and gels have not been evaluated or approved by the FDA for safety or efficacy,” the warning went on to explain that, “The agency is also not aware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children.”

Hyland’s responded by announcing that they would no longer distribute teething medications in the U.S. The manufacturer stood by its claim of safety, and attested that the decision to stop U.S. distribution was based on “confusion among parents and limited access to the medicines” due to the FDA’s recent warning.

In January 2017, after finding that belladonna levels in Hyland’s teething tablets vastly exceeded the safe levels advertised on the label, the FDA advised consumers to stop using teething tablets immediately and throw them away.

The FDA urged Hyland’s to issue a recall of their teething products.

In April 2017, four months after the FDA initially asked Hyland’s to remove their products from shelves, the company issued a recall of all teething tablet products.

 

Thus, we are left with the question – Does Hyland’s care?

The answer is almost certainly not. Despite having knowledge of the hundreds of teething tablet injuries, the company repeatedly refused to issue a recall. Hyland’s even went as far as telling parents that they should continue to use the products. Parents trusted this company and their “natural products.” Hyland’s misused this trust and convinced parents they had fixed their manufacturing issues. Only after the FDA released multiple warnings about Hyland’s teething tablets, and urged for months for the company to step in, did Hyland’s finally recall their product.

While Hyland’s ignored safety signals and circumnavigated around a full recall, hundreds of innocent infants suffered life-threatening teething tablet injury and countless family members had to deal with the devastating consequences of the manufacturer’s actions.

 

Teething Tablets Lawsuit

Hyland’s teething tablet lawsuits are currently being investigated since the U.S. Food and Drug Administration (FDA) has received reports of 400 injured children and 10 deaths that may be linked to belladonna poisoning.

What is Belladonna?

Belladonna is a poisonous plant native to Europe and parts of Asia that has been used as a homeopathic medicine for centuries. Although widely regarded as unsafe to eat, belladonna is frequently used in homeopathic medicines to treat the following ailments:

  • Parkinsons disease
  • Asthma
  • Whooping cough
  • Cold and hay fever
  • Colic
  • Motion sickness
  • Painkiller

Belladonna is also used in certain homeopathic teething tablets used to calm a teething baby, but it now appears that the amount of belladonna used in these products are inconsistent and the amount may be toxic to infants.

Janet Woodcok, M.D., director of the FDA’s Center for Drug Evaluation and Research, is now warning parents:

“We recommend that parents and caregivers not give these homeopathic teething tablets to children and seek advice from their health care professional for safe alternatives.”

According to the FDA, products like Hyland’s Homeopathic teething tablets and gels that contain belladonna puts children under the age of two years old at unnecessary risk.

Homeopathic Teething Products Not FDA-Approved or Recalled

Contrary to common belief, homeopathic teething products have been neither evaluated nor approved by the FDA for safety and effectiveness, and the agency is unaware of a proven health benefit from using them, although they are labeled to relieve teething symptoms in babies and young children.

Manufacturers that put profits over public safety by not telling the truth about the risks, should be held accountable for the injuries that result. These are dangerous reactions to an FDA warning and to news that these products may be tied to the death of an infant.

Instead of immediately removing the products from the market, as instructed by the FDA, The CEO of Hylands appeared to be most concerned about the loss of jobs at his company as a result of these warnings. In a recent interview with CNN, John P. (“Jay”) Borneman noted that the discontinued sale of these products:

“sadly resulted in the loss of 24 jobs.”

Should I File a Hylands Teething Tablet Lawsuit?

A corporation, by definition, is profit-seeking. There is no requirement that a corporation acts morally. Unfortunately, too often we see dangerous products remain on the market when corporations prioritize profit over people, as we believe is the case with Hylands Teething Tablets.

If Standard Homeopathic Company had warned parents of the risk of soothing their children with belladonna and parents had still used the product, there would be no case. But, as we noted above, we are pursuing lawsuits on behalf of families who were not warned of these risks and who would never have used Hylands Teething Tablets if they had known of the risk associated with the product.

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