FDA Says Teething Medicines Could Be Dangerous to Children

Following years of warnings about the possible dangers of teething meds, the FDA has announced that an active ingredient in teething medications could be harmful to children, and has asked companies to stop selling products that contain it.

On Wednesday, health officials in Washington warned parents that teething gels and cream that contain benzocaine can cause serious side effects in children.

They warn that the side effects are rare but deadly, and are more likely to occur in children under two years old.

FDA Commissioner Scott Gotlieb said in a statement that “we urge parents, caregivers, and retailers who sell them to heed our warnings and not use over-the-counter products containing benzocaine for teething pain.”

In addition to speaking to consumers, the FDA did implicate manufacturers of the teething gels and creams in their latest announcement.

Manufacturers have been asked to comply with the request to stop selling teething medications as soon as possible, and the FDA has announced that it will take legal action against companies that do not voluntarily stop selling teething gels and creams.

Benzocaine, the active ingredient in many teething gels and creams that is the believed to be harmful to children, is common in many over-the-counter products for adults. Products like Orajel and Anbesol, used to treat ailments like coldsores and toothaches, include benzocaine.

The FDA has stated that the product is sufficiently safe for adults and that benzocaine products for adults can remain on the market. However, the FDA has requested that companies put warning labels on products geared towards adults, because severe side effects can also appear in adults.

Allegedly, benzocaine can cause a rare, but potentially deadly blood condition. This condition is linked to breathing problems. In this condition, benzocaine can interfere with a protein that carries oxygen in the blood. This condition appears though symptoms including shortness of breath, headache, and rapid heart rate. This condition is more likely to occur in infants than adults.

To make this determination, the FDA reviewed 119 patient cases that linked benzocaine to the blood disorder, that occurred between 2009 and 2017. The FDA reports that among these cases, four patients died as a result of the blood disorder.

Though products like Orajel for adults will stay on the market, Baby Orajel will have to be removed under the new regulation, because it includes benzocaine.

Orajel’s manufacturer, Church and Dwight Co. Inc. responded to the FDA’s instructions by saying that they would discontinue four teething brands, including Orajel Medicated Teething swabs.

However, in a statement made to USA Today, the company did stress that they are not discontinuing other Orajel products geared towards adults, which make up the majority of the Orajel products the company sells.

Wednesday’s new restrictions follow years of warnings by the FDA about the dangers of benzocaine to children. The agency has warned about teething products for decades, noting reports of injury and death.

Most recently, the FDA has issued warnings in 2006, 2011, and 2014, about benzocaine. At the time, they did not instruct companies to stop selling products that used the ingredient.