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Hyland's Teething Tablets May Cause Severe Side Effects In Babies

Homeopathic teething products may cause severe side effects, including seizures, in children. Some families could be entitled to pursue legal action.

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Content Author: Laurence Banville
Edited By: Emily Smith
Published: 1010/2626/16161616
Fact checked on: 1010/2626/16161616
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The US Food & Drug Administration has warned parents and caregivers of a potential link between homeopathic teething products and severe side effects in babies, including seizures. In a press release published on September 30, 2016, the federal health agency advised consumers to stop using homeopathic teething tablets and gels immediately, noting products manufactured by Hyland’s Homeopathic, Orajel and CVS.

Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research says that “teething can be managed without prescription or over-the-counter remedies.” The agency continues to investigate the apparent association between homeopathic teething tablets and child injuries. Product testing is ongoing, although no firm timetable has been set for further public announcements.

Homeopathic Teething Products & Injuries In Babies

Designed to ease the pain and discomfort of teething, homeopathic teething tablets and gels contain trace amounts of atropa belladonnaone of the world’s most toxic plants.

Belladonna is an inherently dangerous substance, according to Healthline. The plant’s leaves and berries contain two anticholinergic chemicals, which disrupt the body’s nervous system, inhibiting digestion, circulation and respiration. Belladonna poisoning can be fatal. In Medieval England, the plant was frequently used as a method of execution.

Despite these risks, homeopathic companies continue to put belladonna in products manufactured explicitly for use in babies, including the teething tablets and gels made by Hyland, Orajel and CVS.

Side Effects Consistent With Belladonna Poisoning

Over the last six years, the FDA has received hundreds of reports of children suffering seizures, difficulty breathing and excessive sleepiness after being given homeopathic teething tablets and gels. FDA reports suggest that the side effects linked to homeopathic teething products are consistent with acute belladonna poisoning:

  • seizures
  • dry mouth
  • dilated pupils
  • skin flushing
  • increased heart rate
  • high body temperature
  • difficulty breathing
  • lethargy
  • abnormal sleepiness
  • disorientation
  • hallucinations
  • muscle weakness
  • urination difficulty
  • constipation

Immediate medical attention is necessary if a child begins to experience any of these symptoms after being given a homeopathic teething tablet or gel.

According to FDA researchers, products like Hyland’s Teething Tablets and Gels “may pose a risk to infants and children.” Tragically, at least 10 infant deaths have already been linked to the products, the New York Times reports. While the agency has yet to confirm an association, current recommendations are strong: “stop using these products” and dispose of any in your possession.

“Inconsistent” Belladonna In Hyland’s Teething Tablets

This is not the first time homeopathic manufacturers have been warned about their teething tablets and gels.

In 2010, the FDA cautioned consumers about the potential risk of harm posed by Hyland’s Teething Tablets. After the agency received reports of seizures and respiratory problems in babies, Hyland came under federal investigation. Soon after, laboratory testing discovered “inconsistent” amounts of belladonna in the company’s teething tablets. When using inherently dangerous substances, it’s critical that manufacturers control the amount of these substances carefully. But federal investigators found evidence of “substandard control of the manufacturing operation” at Hyland’s production facility.

Hyland quickly issued a voluntary recall of the Teething Tablets. After “reformulating” the product, reports, the company renewed distribution. Hyland’s Teething Tablets and Gels reappeared on store shelves across the country in 2011.

CVS, Walgreens Discontinue Teething Product Sales

Five years later, the FDA has again warned caregivers to stop using Hyland’s homeopathic teething products. Over 400 adverse events, and 10 child deaths, are currently under investigation. All of these injuries occurred after Hyland supposedly “reformulated” its teething tablets and gels.

In an interview with Medical Daily, FDA spokesperson Lyndsay Meyer said that initial FDA review “shows that these adverse events are similar to those observed in 2010.”  But this time, Hyland has not issued a recall. Instead, the company has voluntarily ended distribution of its teething tablets and gels, but the products may still be available in stores.

Some major retailers, however, have decided to take action. On September 30, 2016, CVS Pharmacy announced that it had removed “all brands of homeopathic teething products sold in its retail stores and online.” The company’s voluntary withdrawal covers:

  • Hyland’s Baby Teething Gel, .5 oz
  • Hyland’s Baby Teething Tablets, 13 Count
  • Hyland’s Baby Teething Tablets, 135 Count
  • Hyland’s Teething Gel, .33 oz
  • Hyland’s Baby Nighttime Teething Tablets, 135 Count
  • Baby Orajel Naturals Gel for Teething Pain, .33 oz
  • Baby Orajel Naturals Gel for Teething Pain Nighttime Formula, .33 oz
  • Baby Orajel Naturals Tablets for Teething Pain, 125 Count
  • CVS Homeopathic Infant’s Teething Tablet, 135 Count
  • CVS Homeopathic Infant’s Teething Liquid, .85 oz

CVS’ withdrawal is ongoing. As the company’s efforts to remove the products continue, a “do not sell” block has been programmed into CVS register computers, which should prevent additional sales of any homeopathic teething tablets or gels. Walgreens has followed suit, removing the products from store shelves, according to reporting from CNN Health.

Homeopathic Teething Tablet & Gel Lawsuits

Our experienced attorneys believe that thousands of families may be able to pursue justice against the manufacturers of homeopathic teething products. If your child suffered any side effects of belladonna poisoning after being treated with a homeopathic teething tablet or gel, contact our lawyers today to discuss your family’s legal options. Some parents may be eligible to file a product liability lawsuit, seeking financial compensation for medical expenses and pain and suffering.

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