What are Hyland’s Baby Teething Tablets?
Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets, manufactured by Standard Homeopathic Company, are non-FDA approved tablets designed to ease the pain of infant teething.
Hyland’s website claims they have produced “safe, effective and natural health solutions… for over 90 years”. But on a recent tour of the Standard Homeopathic Company facility in Los Angeles, the Food and Drug Administration found belladonna alkaloids that “far exceeded the label claim” for the drugs. This prompted the federal agency to issue an immediate letter that included an April 10th deadline for the company’s discontinuation of the manufacture and distribution of their teething products. The Hyland’s teething tablet line has been linked to 10 infant deaths and close to 400 seizures.
Who is affected by this recall?
Any person who has purchased or used Hyland’s Baby Teething Tablets or Hyland’s Baby Nighttime Teething Tablets, at any time, is encouraged to immediately discontinue use and dispose of any remaining product immediately. According to the formal FDA press release, “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 tablets or gels.”
What is a homeopathic medication?
Homeopathic medications are remedies that have not been shown by the FDA to have “any medical value”. They often come in the form of herbs, oils or tablets. These “medications” are particularly worrisome for the FDA because they remain completely unregulated. However, the FDA is a federal agency and does reserve the right to inspect manufacturing facilities and issue public communications regarding the safety of any homeopathic remedy, as is the case with Standard Homeopathic Company’s Hyland’s Teething Tablets.
What is a Belladonna?
Belladonna, also known as “deadly nightshade”, is an extremely poisonous plant native to North West Europe. The perennial plant contains toxins including atropine, scopolamine and hyoscyamine, which cause hallucinations and “bizarre delirium”. The plant was used in early medications and gets it’s name belladonna, or “beautiful woman”, from its use in ancient eye drops intended to dilate the pupils of elite women in an effort to make them more attractive to male suitors. Belladonna has also been used as a lethal poison for centuries, with documents of its deadly use dating back to ancient Rome.
The FDA & Hyland’s Baby Teething Tablets
On September 20, 2016, the FDA inspected the Standard Homeopathic Company facility in Los Angeles after reports of infant seizure and death related to their Hyland’s Baby Teething Tablets products. The federal agency found disturbing levels of belladonna alkaloids that far exceeded the the amount listed on the drugs packaging. The agency immediately sent a letter requesting voluntary withdrawal of the teething tablets from the market stating, “This variability in belladonna alkaloid concentrations indicates a fundamental lack of control over the content of toxic chemicals in your drugs.” Standard Homeopathic responded to the demands of the FDA with a letter stating that the company planned to cease production and distribution of the products no later than October 7, 2016. The FDA then gave SHC two months to fulfill it’s promise but the company did not comply.
On January 16, 2017, Standard Homeopathic Company was met with a second letter demanding immediate removal of all Hyland’s Baby Teething Tablets from the American market. SHC responded “that the public is amply protected.” The FDA then gave the manufacturer a deadline of April 10th, 2017, to voluntarily remove the product from the market, or they would issue a Class I recall; a warning that a product will cause serious adverse health consequences or death.
On April 13th, 2017, Standard Homeopathic Company complied and issued a voluntary recall of all Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets. The SHC website now contains an unclear warning saying, “It is therefore with much sadness that we share with you that we have chosen to discontinue the distribution of our Hyland’s teething medicines in the United States. This decision was made in light of the recent warning issued by the Food & Drug Administration (FDA) against the use of homeopathic teething tablets and gels. This warning has created confusion among parents and limited access to the medicines.”
Have others been affected by Hyland’s Baby Teething Tablets?
KTLA 5 reported on the nearly 400 adverse events caused by Hyland’s Baby Teething Tablets. The news company stated the homeopathic tablets had caused severe health complications in infants including fever, lethargy, vomiting, sleepiness, tremors, shortness of breath, irritability and agitation, all occurring over the past six years. They went on to quote the tablet manufacturer, Standard Homeopathic Company as saying, “[this ruling puts] you in a position of having to choose who to trust in the face of contradictory information is burdensome and undermines the FDA.” There have been 10 confirmed infant deaths due to Hyland’s Baby Teething Tablets. Standard Homeopathic Company is estimated to generate $25-$50 million in yearly revenue.