FDA Warns of Dangers, Deaths Associated With Teething Tablets and Gels

In response to a warning about the health dangers and deaths associated with homeopathic teething tablets issued by the U.S. Food and Drug Administration, CVS Health Corp. pulled all brands of homeopathic teething products from its shelves on Sept. 30, 2016.

While the FDA didn’t identify any particular brands of teething products in its warnings to parents and care providers, Hyland’s, one of the best known of the homeopathic teething tablets, has already chosen to remove its product from the United States’ market.

At this time, the federal agency has determined a possible link between 400 cases of adverse reactions in infants who had been given the teething tablets or teething gel and 10 deaths. In an email, the FDA further clarified its position on the teething tablets and adverse reactions that may have resulted from their use:

“It is important to note that while adverse event reports give us some information about a product and serious injuries or deaths related to use of a particular product, they often indicate situations that require additional analysis and do not constitute conclusive evidence of a problem with the product.”

Homeopathic Teething Tablets and/or Gels Linked to 400 Known Cases of Adverse Reactions and 10 Deaths

Further investigation will be required before an actual cause-and-effect between the tablets and the adverse reactions and deaths, but the agency charged with the safety and efficacy of prescription medications, and the same with over-the-counter medications, when brought to the agency’s attention, is erring on the side of caution in an attempt to prevent any further health issues or deaths that may result from the use of the homeopathic teething tablets.

Adverse reactions that have been reported after use of teething tablets in infants and toddlers include fever, lethargy, irritability, seizures, tremors and in 10 cases, death.

Hyland’s, for its part, issued a statement on Oct. 1, 2016, the day after the FDA released its most recent warning that says in part:

“We want you to know that we are confident that Hyland’s Baby Teething Tablets remain safe. Of course, parents who may have concerns should consult with their physicians before using any medicines, read labels carefully and follow all instructions.

Homeopathic medicines are regulated as drugs by FDA. We are fully cooperating with FDA’s inquiry and we’re providing them with all the data we have. We also hope to learn from FDA what facts, if any, the Agency has based its action on.”

On October 11, 2016, Hyland’s issued a letter to consumers explaining that the company regrets having to do so, put they will no longer be distributing their teething tablets and gels in the United States due to the FDA’s warnings. Parents and care providers in Australia and Canada, where Hyland’s also selling its products, may want to give consideration to the U.S. FDA’s warning.

Hyland’s Voluntarily Withdrew Teething Tablets and Gels From U.S. Market But Then Returned

The FDA first issued a warning in October 2010 about Hyland’s teething tablets. Of concern at that time was that the tablets contained a small amount of belladonna, an age-old plant-derived substance that in anything greater than small quantities can have serious, evenly deadly effects.

The agency listed among its concerns in the 2010 warning that in addition to the use of belladonna in their homeopathic teething tablets, the product at that time came without a child-proof cap and that the manufacturing process lacked adequate control to ensure belladonna or any other ingredients were used in the quantities intended while noting that there was no “proven clinical benefit” to the product.

Warnings to parents and caregivers to seek medical attention if an infant or toddler who had taken the teething tablets exhibited symptoms ranging from difficulty breathing, muscle weakness, difficulty with urination, constipation or excessive sleepiness.

Hyland’s voluntarily withdrew its teething tablets from the U.S. Market at that time, but subsequently re-entered that same market with the only change noted to be that the bottles of tablets now had a child-proof cap.

What Is Homeopathic Medicine?

Homeopathy, or homeopathic medicine, is an alternative form of medicine that was first developed in Germany more than two centuries ago. The Nation Center for Complementary and Integrative Health summarizes homeopathy in this way:

“Supporters of homeopathy point to two unconventional theories: “like cures like”—the notion that a disease can be cured by a substance that produces similar symptoms in healthy people; and “law of minimum dose”—the notion that the lower the dose of the medication, the greater its effectiveness. Many homeopathic remedies are so diluted that no molecules of the original substance remain.”

Because homeopathic remedies are made from natural origins – plants, minerals, animals and some insects – some people are under the impression that “natural” means “safe.” This is not always so, considering that arsenic and hemlock are natural substances and some of the oldest poisons in the world.

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