FDA: Some teething remedies can cause possibly fatal side effects in babies

  • FDA: Some teething remedies can cause possibly fatal side effects in babies

FDA: Some teething remedies can cause possibly fatal side effects in babies

This risky condition is the result of elevated levels of methemoglobin in the blood and it can lead to death. They include pale, gray- or blue-colored skin, lips, and nail beds; shortness of breath; fatigue; headache; lightheadedness; and a rapid heart rate. The symptoms can start minutes after a product is used or up to one to two hours later. Babies who experience these problems should get medical attention immediately. If they do not comply, the FDA says it will "will initiate a regulatory action to remove these products from the market".

Products containing benzocaine carry serious risks and provide little to no benefits for treating oral pain, including sore gums due to teething, the FDA says.

Benzocaine is found in gels, sprays and lozenges for teething, canker sores, sore throats and toothaches, for both adults and children. Those marketed to adults can stay on the market but may need new label information.

Benzocaine is marketed as a pain reliever for babies who are teething.

The crying echoes through your house - your teething baby is miserable, and all you are wishing for is some peace for the both of you.

The agency said Wednesday that various gels containing the drug benzocaine can cause rare but deadly side effects in children, especially those 2 years and younger. At that time, the FDA was aware that methemoglobinemia was a rare reaction to benzocaine; it had received a total of 319 reports of this particular complication, not limited to children.

This is not the first warning about benzocaine from the FDA. In 2011, the agency warned consumers about the methemoglobinemia potential of the products. Officials reviewed 119 cases of the blood disorder linked to benzocaine between 2009 and 2017, including four deaths, according to the FDA. There are probably additional cases that weren't documented. The FDA also outlined these safety concerns in letters that the agency sent to manufacturers of these products. It suggests that parents can rub their babies' gums to give them temporary relief. It is made by the New Jersey-based Church and Dwight Co.

Revising the directions to direct parents and caregivers not to use the product in infants and children younger than 2 years.