FDA warns against the use of homeopathic teething tablets and gels

FDA warns against the use of homeopathic teething tablets and gels

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm523468

The U.S. Food and Drug Administration is warning consumers that homeopathic teething tablets and gels may pose a risk to infants and children. The FDA recommends that consumers stop using these products and dispose of any in their possession.

Homeopathic teething tablets and gels are distributed by CVS, Hyland’s, and possibly others, and are sold in retail stores and online.

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.

“Teething can be managed without prescription or over-the-counter remedies,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “We recommend parents and caregivers not give homeopathic teething tablets and gels to children and seek advice from their health care professional for safe alternatives.”

The FDA is analyzing adverse events reported to the agency regarding homeopathic teething tablets and gels, including seizures in infants and children who were given these products, since a 2010 safety alert about homeopathic teething tablets. The FDA is currently investigating this issue, including testing product samples. The agency will continue to communicate with the public as more information is available.

Homeopathic teething tablets and gels have not been evaluated or approved by the FDA for safety or efficacy. The agency is also not aware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children.

The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of homeopathic teething tablets or gels to the FDA’s MedWatch Adverse Event Reporting program:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

3 Responses

  1. This makes me think of the FDA halting the manufacturing and dispensing of an old type of ear drop (containing benzocaine) for ear aches last year. I’ve used these ear drops for many years on an occasional basis. When my allergies act up, some of the fluid clogs up that tube to my ears, which can cause me to have sharp pains in my ears at times. Here’s the thing – these ear aches are extremely random, sometimes just lasting a few minutes. There is no oral medication that could help the pain (I already take allergy pills and nasal spray) because it’s so random and often does not last very long. These ear drops are life-savers. I (like millions of other parents) have also used these drops on my son when he was little and would suffer ear aches due to head colds and/or allergies. It is beyond ridiculous that the FDA did this! There was absolutely no logical reasoning behind this, (though I realize that when it comes to our government alphabet gangs, logic and reasoning does not happen).

    http://www.medscape.com/viewarticle/847373

  2. I used Baby Oragel and similar products, cold rags, etc everything that I was told to use and I still sat up nights with a crying teething child. (we won’t mention the now ex who I found out didn’t want to deal with any of it) When my sibs and I were teething back in the 60s, my mother used to be able to sign out 2 oz of Paragoric to rub on the gums and it worked. To be honest when all and an of the the above products did not work and I had to be at work early in the AM, a finger dipped in Jim Beam did the trick and rubbed on the gums did the trick. Not that I would recommend to everyone, but an old wives tale treatment worked and we both got sleep that night. And for the record, my kids are not alcoholics or addicts in any form now as adults. I suggest if the FDA is going to start taking teething products off the market, Mothers everywhere start sending their crying teething children to the FDA and let them deal with them so they can see the reality we have and had to deal with.

  3. As a foster parent for 25 years and over 150 infants and toddlers I used teething tablets without incident on MANY kids. Not only did they give a huge amount of relief to both the babies and myself but never had a single adverse reaction! What game are these idiots playing with our lives? Are they going to attack any and all types of pain relief,especially if they are not invasive and the cause of more pain?

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