August 15, 2018

FDA warns parents - teething medications are not safe for babies

25 May 2018, 09:48 | Rodolfo Wallace

FDA warns: Don’t let your children sink their teeth into benzocaine

Health officials warn of teething gel side effects

The officials in their statement this Wednesday (23rd May 2018), say these remedies normally contain a numbing agent that numbes the gums of the babies and prevent teething woes.

"If companies do not comply", the FDA said it will "initiate a regulatory action to remove these products from the market". Products for adults can remain on the market but the FDA wants companies to add new warnings.

Health officials have previously warned consumers about benzocaine, which can cause a rare but life-threatening blood condition, especially in children under age 2.

The FDA warnings regarding benzocaine in baby teething products have been issued in the past in 2006, 2011 and 2014. The AAP does not recommend these gels and suggests teething rings and massaging the gums to ease the teething pain.

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The academy has noted that pain relievers and gels used on the gums of teething children are generally not effective because they wash out of a baby's mouth within minutes, FDA said.

The Food & Drug Administration posted a press release on its website today with the headline, "FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit".

Benzocaine-containing products sold over the counter to relieve babies' teething pain are too risky and should no longer be sold, the FDA said Wednesday. A study comparing the relative ability of benzocaine and lidocaine to make methemoglobin showed that benzocaine generated much more methemoglobin than lidocaine in a red blood cell model. The OTC benzocaine products should only be used sparingly in adults, and children 2 years and older and not more than four times a day. They say using these products can lead to a serious and sometimes fatal condition. Symptoms include shortness of breath, headache and rapid heart rate. Manufacturers of approved, prescription local anesthetics will have 30 days to reply to the FDA's letter regarding these new Safety Labeling Changes. Healthcare professionals who use local anesthetics are being advised to minimize the risk of methemoglobinemia by monitoring patients for signs and symptoms, using co-oximetry when possible, and having resuscitation equipment and medications available, including methylene blue.

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