Homeopathic Teething Products Linked to Child Deaths, FDA Says

more+
less-

Belladonna is blamed for the deaths of 10 babies. The parents treated their teething phase with homeopathic teething products (gels and tablets) containing the natural substance.

Another name for belladona is deadly nightshade, which it received due to its poisonous nature. Still, the plant has been used medicinally for five centuries.

Food & Drug Administration Gets Involved

The U.S. Food and Drug Administration (FDA) has reported 400 adverse events in connection with the homeopathic remedy. The remedy intended to ease the pain of teething. In addition, the adverse events included seizures.

“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,” the agency said in a news release titled “FDA warns against the use of homeopathic teething tablets and gels.”

The FDA is investigating the problem but did not issue a recall. Unfortunately, homeopathic gels and tablets are not evaluated by the agency. However, six years ago, the FDA issued a safety alert for Hyland’s Teething Tablets; it stated the products might pose a risk to children.

“FDA analysis and testing identified some Hyland’s Teething Tablets that contained varying amounts of belladonna, a potentially toxic ingredient,” according to the safety alert. “FDA has received reports of serious adverse events in children taking this product that are consistent with belladonna toxicity.”

CNN reported that CVS and Walgreens stores have pulled the Hyland’s items, as well as other brands of homeopathic gels and tablets used during teething, from it shelves. Parents are warned to stop administering such products and contact their healthcare professionals in the event their children experience any of the symptoms.

Hyland’s has discontinued the items in the United States. In a statement emailed to CNN, the company indicated it “has not been made aware of any data that supports the claims in the warning against our teething tablets and gels” and said it is unaware of statistics showing a causal link.

Manufacturer Recalls and Reformulates Teething Products

In 2010, after the safety alert came out, Hyland’s recalled its teething products. It tested them in the lab, found that different batches had different amounts of belladonna and, as a result, reformulated the gels and tablets and put them back on the market. In response to the news release distributed Sept. 30, 2016, the company issued a letter with the salutation “Dear Moms and Dads.”

“Many retailers, because of the announcement, have chosen to stop selling homeopathic teething medicines in their stores while others have not,” the letter states. “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.”

Parents of teething children have options, according to the American Academy of Pediatrics. Parents can massage their baby’s gums or give them a teething ring or a wet washcloth from the freezer. They can also try to feed them frozen bananas.

“Find something for your little gnawer that’s cool to touch but tough to chew on…,” the Web site states. “And know that it’s absolutely fine to let your baby chew all day if he or she enjoys it.”


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Searcy Denney Scarola Barnhart & Shipley | Attorney Advertising

Written by:

more+
less-

Searcy Denney Scarola Barnhart & Shipley on:

JD Supra Readers' Choice 2016 Awards
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×
Loading...
×
×