Dangerous Teething Products
In recent years, the FDA has issued multiple strongly-worded warnings about severe risks associated with gels and tablets designed to reduce teething discomfort in babies. Numbing agents in these products have been associated with more than 400 adverse event reports and at least 10 deaths.
Our dangerous products lawyers are currently investigating teething gel lawsuits on behalf of families who suffered a child’s injury or the wrongful death of a child due to use of unsafe teething products.
Homeopathic Teething Gels and Tablets
The FDA has issued multiple warnings about potential risks and side effects associated with homeopathic teething gels and teething tablets.
In 2010, regulators warned that Hyland’s Teething Tablets may pose a serious risk to children and encouraged parents to immediately discontinue use of this product and dispose it. Hyland’s Teething Tablets contain small amounts of belladonna, an herb also known as “deadly nightshade” which can be harmful or even fatal at high doses.
The FDA stated at this time that multiple factors may contribute to belladonna toxicity linked to Hyland’s Teething Tablets: “FDA laboratory analysis...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.”
Symptoms of belladonna toxicity may include:
- Difficulty breathing
- Excessive sleepiness
- Muscle weakness
- Skin flushing
- Difficulty urinating
As a result of the FDA’s investigation into potential risks associated with these homeopathic teething products, Hyland recalled them. A “reformulated” version of the product was sold beginning in 2011.
New FDA Warnings about Homeopathic Teething Products
In the years since the 2010 warning about belladonna teething products, the FDA has received at least 400 reports of children who experienced symptoms of belladonna toxicity after using homeopathic teething products, and 10 of these cases were fatal.
This prompted regulators to resume their investigation into homeopathic teething products featuring belladonna. On September 30, the FDA issued a new teething product warning which applies to a number of homeopathic products containing belladonna, including but not limited to:
Baby Orajel Naturals Gel for Teething Pain Nighttime Formula, .33 oz
Baby Orajel Naturals Gel for Teething Pain, .33 oz
Baby Orajel Naturals Tablets for Teething Pain, 125 Count
CVS Homeopathic Infant’s Teething Tablet, 135 Count
CVS Homeopathic Infants’ Teething Liquid, .85 oz
Hyland’s Baby Nighttime Teething Tablets, 135 Count
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
In response to this warning, many major retailers including CVS and Walgreens removed all homeopathic teething products from store shelves.
Hyland’s also opted to discontinue all sales of their belladonna teething products in the United States, stating:
Our first commitment is to you, the parents who trust us every day with the wellbeing of your families. Putting you in a position of having to choose who to trust in the face of contradictory information is burdensome and undermines the FDA. We are committed to supporting you with quality homeopathic medicines as you tackle the incredibly challenging – and rewarding – role of raising your children.
Many retailers, because of the announcement, have chosen to stop selling homeopathic teething medicines in their stores while others have not. We are confident that any available Hyland’s teething products, including those you already have, are safe for use. Of course, parents who may have concerns should consult with their physicians before using any medicines, read labels carefully and follow all instructions.
Benzocaine and Lidocaine Teething Gels
In 2006 and 2011, the FDA warned that benzocaine, the main ingredient in over-the-counter teething gels, has been linked to a rare but serious condition known as methemoglobinemia, which decreases the amount of oxygen in the blood and can lead to life-threatening complications and even death. These gels can also lead to seizures, brain injury and heart problems.
Since the FDA first warned against these products in 2006, there have been 29 reports of benzocaine gel-related cases of methemoglobinemia. The FDA followed its 2006 warning with another warning in 2011.
The agency warned that cases of methemoglobinemia are often accompanied by symptoms such as:
Pale, gray, or blue-colored skin, lips and nail beds
Shortness of breath
Rapid heart rate
Parents should be aware that symptoms of benzocaine side effects may occur within hours of the first use, but they can also occur after several uses.
According to the FDA, “If your child has any of these symptoms after using benzocaine, stop using the product and seek medical help immediately by calling 911. Methemoglobinemia caused by benzocaine may require treatment with medications and admission to a hospital. Serious cases should be treated right away. If left untreated or if treatment is delayed, methemoglobinemia may cause permanent injury to the brain and body tissues, and even death, from the insufficient amount of oxygen in the blood.”
In 2014, the FDA issued a Black Box Warning for all prescription oral viscous lidocaine 2 percent solutions, used to treat teething pain in infants and children and oral pain in adults. The FDA stated, “When too much viscous lidocaine is given to infants and young children or they accidentally swallow too much, it can result in seizures, severe brain injury, and problems with the heart. Cases of overdose due to wrong dosing or accidental ingestion have resulted in infants and children being hospitalized or dying.”
Alternatives to Teething Products
According to a number of experts including the American Academy of Pediatrics, there are multiple options parents can turn to instead of using potentially dangerous gels and tablets to ease teething pain. It is recommended that infant formulas of over-the-counter pain relievers like acetaminophen may be used. Additionally, frozen teething rings or frozen bagels, bananas, berries, or washcloths dipped in water may provide some relief to tender gums.
Contact an Experienced Teething Gel Attorney
If your child or loved one has injured through the use of the use of homeopathic teething gels or teething gels containing benzocaine or lidocaine, you should be aware of your potential right to compensation. The lawyers at Kelley Bernheim Dolinsky, LLC offer free and confidential evaluations for those who feel they have been injured through the use of these products. Please contact us today to learn more about your rights.