As babies begin teething, parents look for products that can help soothe the child and provide pain relief, such as teething tablets, gels, sprays, ointments, solutions, and lozenges.
Teething products have been around since the early 1900s and are supposed to provide temporary relief for the teething infant, but the products have been linked to dangerous side effects.
Reportedly, teething products contain:
Belladonna is a poison that can cause injury and death. Hyland’s teething products that contain belladonna, according to FDA adverse event reports, have caused hundreds of injuries in infants and multiple infant deaths.
Over-the-counter Benzocaine products are also dangerous.
After reports of serious injuries, the FDA issued a warning to consumers stating that due to the growing number of reports and lack of efficacy, they would begin to investigate the teething products containing Benzocaine.
The products listed in the warning are sold as gels, sprays, ointments, solutions, and lozenges under the following names:
Belladonna commonly referred to as “deadly nightshade”, is a poisonous plant native to Europe and parts of Asia that have been used as a poison since Roman times. Belladonna has been used in homeopathic products.
The amount of belladonna that exists in Hyland’s teething products is inconsistent and could cause belladonna poisoning, which may be deadly to infants.
Janet Woodcock, 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 healthcare professional for safe alternatives.”
According to the FDA, products like Hyland’s Homeopathic teething tablets and gels that contain inconsistent amounts of belladonna put children under the age of two years old at unnecessary risk.
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 these products.
Hyland’s Teething Tablets are a dangerous, homeopathic remedy that has been advertised to temporarily soothe a teething baby.
Reports of serious side effects, including death, were brought to light as early as 2006.
In 2017, a teething tablets recall was finally issued.
Since then, TorHoerman Law has filed a teething tablet lawsuit to hold the manufacturer of these dangerous products liable for their negligence.
Contrary to common belief, homeopathic teething products have never been approved by the FDA for safety and effectiveness.
Multiple infant deaths were reported to Hyland’s and the FDA and should have been an early warning sign that there was a serious safety issue with the Hyland’s Teething Tablets – an issue that could not be ignored.
Yet, more tragic stories of teething tablet injury would soon follow.
Since hundreds of injuries and many deaths have been reported to the FDA, the agency has announced it will propose new, risk-based enforcement priorities to protect consumers from potentially harmful, unproven homeopathic drugs.
According to the FDA, homeopathic medicines have brought more than $3 billion to the industry, but it is largely unregulated.
As a result, the FDA has vowed to take a more serious look at the processes and take steps to prevent other individuals from being injured in the way many infants were due to Hyland’s Baby Teething Tablets.
In December 2017, the Food & Drug Administration (FDA) announced they will begin to crack down on the dangerous homeopathic medicine industry. This is a welcome announcement to the many who criticize the industry for producing products that could be contaminated with dangerous ingredients, such as infant teething tablets containing belladonna, or selling products that are designed to treat serious conditions in lieu of medically approved products that will treat the illness.
In recent years homeopathic medicinal products have come under fire for being unsafe and unhelpful. In the past ten years, Hyland’s has sold infant teething tablets that contained unsafe amounts of the toxic, but natural, chemical, belladonna. In 2016, there were reports of more than 400 injuries and 10 deaths allegedly caused by the teething tablets.
According to the FDA, the dangerous homeopathic medicine industry has grown into a $3 billion enterprise, but it remains largely unregulated. Since the 1988 decision, the FDA has not regulated homeopathic medicinal products the same as they would for standard medical products. Similar to dietary supplements, homeopathic products are not reviewed for safety or effectiveness by the FDA. Unlike dietary supplements though, homeopathic medicinal products can state on the label what the product is intended to treat. It is for that reason many believe the products should be regulated under the same criteria as FDA-approved pharmaceuticals or medical devices.
The 1988 decision has come under fire in recent years prompting the FDA to revisit the standards with a public hearing which began Monday, Dec. 18, 2017, and will end 90 days from that date. The public is invited to voice their concerns regarding the homeopathic industry by submitting comments to the FDA for review.
The overall goal, according to the FDA, is to begin cracking down on the products that pose the biggest safety risk, such as those for children or serious illnesses.
“We respect that some individuals want to use alternative treatments, but the FDA has a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm,” Dr. Scott Gottlieb, FDA commissioner said.
Benzocaine is the active ingredient used in over-the-counter teething products. It has been advertised to reduce pain but has been associated with a rare, but serious condition called Methemoglobinemia. The condition causes the reduction of oxygen carried in the bloodstream, resulting in severe injury or death. The injuries can include blue or grey nails, difficulty breathing, excessive sleepiness, lethargy, pale skin, seizure, SIDS, or death.
In 2011, the FDA issued a warning about Benzocaine. According to the warning, an estimated 400 or more cases of benzocaine-associated Methemoglobinemia had been reported to the FDA or published in medical literature since 1971.
We are left with the question – Does Hyland’s care?
The answer is almost certainly not. Despite knowing 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 its “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 circumnavigated around a full recall, hundreds of innocent infants suffered life-threatening teething tablet injury and countless family members had to pay the consequences of the manufacturer’s actions.
Now is time for Hyland’s to answer for this astonishing negligence. Hyland’s Teething tablet lawsuits are currently filed and being litigated. Additional teething tablet lawsuits may soon be filed against other manufacturers. As a part of this national litigation, our firm is fighting for retribution for the families affected by Hyland’s actions.
Christensen, Jen. “FDA Warns Parents against Using Teething Tablets and Gels.” CNN, Cable News Network, 5 Oct. 2016, www.cnn.com/2016/10/05/health/fda-teething-tablets-warning/index.html
“Homeopathic Teething Gels and Tablets.” National Center for Complementary and Integrative Health, U.S. Department of Health and Human Services, 27 Mar. 2018, nccih.nih.gov/health/teething
“Homeopathy.” National Center for Complementary and Integrative Health, U.S. Department of Health and Human Services, 24 Sept. 2017, nccih.nih.gov/health/homeopathy.
“Press Announcements – FDA Proposes New, Risk-Based Enforcement Priorities to Protect Consumers from Potentially Harmful, Unproven Homeopathic Drugs.” U.S. Food and Drug Administration Home Page, Office of the Commissioner, 18 Dec. 2017, www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm589243.htm
“Press Announcements – FDA Takes Action against the Use of OTC Benzocaine Teething Products Due to Serious Safety Risk, Lack of Benefit.” U.S. Food and Drug Administration, U.S. Department of Health and Human Services, 23 May 2018, www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608325.htm
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