“Natural” Teething Remedies Also May Be Deadly

Parents may be tempted to try assorted teething remedies for their infants. In October 2014, Worst Pills, Best Pills News warned readers not to use over-the-counter teething products that contained benzocaine because this anesthetic has been linked to a rare but life-threatening blood condition and is not an effective therapy for teething pain.

Parents wary of such drug risks may be tempted to instead try “natural” teething remedies for infants. Yet some of these products may carry the risk of serious side effects, too.

In April, Hyland’s — a division of Standard Homeopathic Company and one of the country’s leading makers of homeopathic products — agreed to recall its brand of infant teething tablets (HYLAND’S BABY TEETHING TABLETS and HYLAND’S BABY NIGHTTIME TEETHING TABLETS)[1] because they have been the subject of a large number of serious injury reports to the Food and Drug Administration (FDA) over the past 10 years.[2]

The recall was in response to a strongly worded letter from the FDA asking Hyland’s to recall its teething tablets.[3],[4] The agency had visited a Hyland’s facility in September 2016 and found significant violations of federal manufacturing quality standards. Testing also revealed that the company’s teething tablets contained widely varying quantities of belladonna, a toxic substance, in some cases far exceeding the amount stated in the product labeling.[5]

Hyland’s had previously agreed to cease production of the tablets in October 2016 but refused to conduct a recall of products that had already been distributed to stores.[6] Instead, the company insisted in an open letter that its products were safe, encouraging consumers to continue using them and complaining that the FDA had created unnecessary confusion for patients.[7]

Homeopathy: Toxins that heal?

The packaging of Hyland’s teething tablets promises “Natural Relief ” from the pain of teething: “No Benzocaine, Artificial Flavors, Dyes or Parabens.” But as most people well know, substances that are natural also can be toxic.

In fact, known toxins are at the heart of homeopathic medicine. The father of homeopathy, Samuel Hahnemann, claimed that a substance that causes symptoms of illness in a healthy person can cure an ill person who has those same symptoms, provided that the substance is administered in very low doses.[8] Homeopathic products thus are supposed to contain trace amounts of substances that, at higher doses, produce toxic side effects that are similar to the symptoms of the illnesses they are intended to treat.

Strong scientific evidence supporting Hahnemann’s philosophy is lacking, and manufacturing standards are not clearly enforced by the FDA for homeopathic products. That is why Worst Pills, Best Pills News urged readers not to use homeopathic products when we reviewed them in 2009.[9]

Repeated warnings, shameful inaction

In February 2011, this newsletter specifically warned readers not to use Hyland’s Teething Tablets.[10] Our warning followed an FDA alert that was uncannily similar to statements the agency would make six years later: The FDA had found significant manufacturing problems during a factory visit and determined through testing that the teething tablets contained variable quantities of belladonna.[11],[12] At that time in 2011, Hyland’s voluntarily agreed to pull the tablets from store shelves and reformulate them, although it insisted they were safe.[13]

But problems continued. Reporter Sheila Kaplan of STAT news recently published details of some of the 370 injury reports involving the Hyland’s teething products submitted to the FDA from 2006 to 2016.[14]

Her reporting described seizures, emergency room visits and deaths in infants who used the tablets, even after the product was reformulated. (Agency officials told Kaplan that the question of whether the products actually caused the reported injuries is still under review).

On Feb. 13, 2012, a mother reported to the FDA that her son had experienced seizures after taking three Hyland’s Baby Teething Tablets. She wrote, “I am shocked at the popularity of this product, which is growing, and the lack of knowledge among parents, as well as the lack of warnings on the labels. Parents desperately need to be warned about this product if it is going to stay on the shelves!!!! Please do something!”

On July 9, 2014, another mother gave her 9-month-old daughter two tablets, crushed, for the first time. Forty-five minutes later, the mother found the child dead in her crib beside a puddle of vomit.

Meanwhile, the FDA shamefully took little action until September 2016, when the agency announced that it was investigating more injury reports related to homeopathic teething products, including Hyland’s, and advised consumers not to use these products.[15] Then, in January 2017, the FDA reported test results demonstrating widely variable levels of belladonna in the reformulated Hyland’s tablets.[16] Yet it was not until April, after the agency’s recall request letter calling the tablets a “serious health hazard,”[17] that Hyland’s finally initiated a product recall.

It remains to be seen whether Hyland’s Homeopathic Baby Teething Tablets are off the market for good. On its website, Hyland’s remains unapologetic, stating that it only issued the recall to comply with the FDA’s demands. “It is important for you to know,” it told customers, “that all manufactured and sold teething medicines met the Company’s safety limit tests.”[18]

What You Can Do

Avoid any pill, tablet, gel or cream that promises to treat teething pain for babies, whether it is labeled “natural” or otherwise. Pain relievers intended to be rubbed on a baby’s mouth are not very helpful because the medication is quickly washed away by saliva. In addition, infants of teething age are especially vulnerable to toxic substances because their livers are not yet fully developed, increasing the risk of serious side effects like those observed with belladonna tablets and benzocaine.

The American Academy of Pediatrics recommends treating teething pain by offering infants something that’s cool to touch but tough to chew on, such as a wet washcloth or teething ring chilled in the freezer for 15 to 30 minutes.[19] (Avoid fully frozen objects, as extreme cold can injure your baby’s mouth.) If medication is needed, talk to your child’s pediatrician about using a small dose of acetaminophen (TYLENOL) or ibuprofen (ADVIL, MOTRIN) for pain relief.[20]

References

[1] Hyland’s. Hyland's teething update. https://www.hylands.com/media/news-press-release/hylands-teething-update. Accessed May 5, 2017.

[2] Kaplan S. Homeopathic remedies harmed hundreds of babies, families say, as FDA investigated for years. February 21, 2017. https://www.statnews.com/2017/02/21/hylands-homeopathic-teething-fda/. Accessed May 5, 2017.

[3] Food and Drug Administration. Letter to Jay Borneman, Chief Executive Officer, Standard Homeopathic Company. April 7, 2017. https://www.fda.gov/ucm/groups/fdagov-public/%40fdagov-afda-orgs/documents/document/ucm552166.pdf. Accessed May 5, 2017.

[4] Hyland’s. Hyland's teething update. https://www.hylands.com/media/news-press-release/hylands-teething-update. Accessed May 5, 2017.

[5] Food and Drug Administration. Letter to Jay Borneman, Chief Executive Officer, Standard Homeopathic Company. April 7, 2017. https://www.fda.gov/ucm/groups/fdagov-public/%40fdagov-afda-orgs/documents/document/ucm552166.pdf. Accessed May 5, 2017.

[6] Food and Drug Administration. FDA confirms elevated levels of belladonna in certain homeopathic teething products. January 27, 2017. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm538684.htm. Accessed April 14, 2017.

[7] Hyland’s. A letter from Hyland’s. October 11, 2016. https://www.hylands.com/hylands-discontinues-teething-tablets-and-gels. Accessed May 5, 2017.

[8] Ernst E. A systematic review of systematic reviews of homeopathy. Br J Clin Pharmacol. 2002;54(6):577-582.

[9] Worstpills.org. A review of homeopathy. October 2009. /newsletters/view/662. Accessed May 5, 2017.

[10] Worstpills.org. Homeopathic teething tablets recalled due to possible belladonna toxicity in children. February 2011. /newsletters/view/729. Accessed May 5, 2017.

[11] Food and Drug Administration. Working with FDA, Standard Homeopathic Company Voluntarily Recalls Hyland’s Teething Tablets to Address Manufacturing Process. October 23, 2010. https://www.fda.gov/Safety/Recalls/ArchiveRecalls/2010/ucm230769.htm. Accessed May 5, 2017.

[12] Kaplan S. Homeopathic remedies harmed hundreds of babies, families say, as FDA investigated for years. February 21, 2017. https://www.statnews.com/2017/02/21/hylands-homeopathic-teething-fda/. Accessed May 5, 2017.

[13] Ibid.

[14] Ibid.

[15] Food and Drug Administration. FDA warns against the use of homeopathic teething tablets and gels. September 30, 2016. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm523468.htm. Accessed May 5, 2017.

[16] Food and Drug Administration. FDA confirms elevated levels of belladonna in certain homeopathic teething products. January 27, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm538684.htm. Accessed May 5, 2017.

[17] Food and Drug Administration. Letter to Jay Borneman, Chief Executive Officer, Standard Homeopathic Company. April 7, 2017. https://www.fda.gov/ucm/groups/fdagov-public/%40fdagov-afda-orgs/documents/document/ucm552166.pdf. Accessed May 5, 2017.

[18] Hyland’s. Hyland’s teething update. https://www.hylands.com/media/news-press-release/hylands-teething-update. Accessed May 5, 2017.

[19] HealthyChildren.org. How to help teething symptoms without medications. https://www.healthychildren.org/English/ages-stages/baby/teething-tooth-care/Pages/How-to-Help-Teething-Symptoms-without-Medications.aspx. Accessed May 5, 2017.

[20] HealthyChildren.org. Teething pain. https://www.healthychildren.org/English/ages-stages/baby/teething-tooth-care/Pages/Teething-Pain.aspx. Accessed April 14, 2017.