FDA: Updated Safety Alert Regarding Benzocaine-Associated Methemoglobinemia

FDA Teething babies don’t need medicine	 	 	 			One year old baby girl sitting sucking her thumb

The U.S. Food and Drug Administration (FDA) published a warning on Wednesday.

Lastly, the FDA has sent a letter to manufacturers asking them to stop selling teething products with benzocaine in them - and said it will take legal action against companies that refuse to comply with the FDA's warning.

The agency said it will take action against companies that don't voluntarily remove benzocaine products for young children.

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 products are not effective for teething since they wash out of the mouth within minutes. More than 400 cases have been reported to the FDA or appear in the medical literature, the agency said in a data summary.

The agency said parents of teething children should follow advice from the American Academy of Pediatrics. The old fashion cure - a gentle massage with your fingers on your child's gums is the go-to treatment.

A common reaction is to go to the local drug store and choose all the products made specifically for teething pain.

Federal health officials are warning parents that over the counter teething products can pose a risk to infants and children.

Director Janet Woodcock said the FDA is working to "add warning information about methemoglobinemia and a contraindication against use for teething pain and against use in children under 2 years of age to the remaining oral health care drug products containing benzocaine".

The problem is the anesthetic ingredient benzocaine (ben'-zo-cane). Elevated levels of methemoglobin cause the amount of oxygen in the body to be reduced.

Benzocaine is sometimes sold under the brand names Orajel and Anbesol and is an ester local anesthetic, often used as a topical pain reliever or in cough drops.

Signs and symptoms of methemoglobinemia include pale, gray, or blue-colored skin, lips, and nail beds; dyspnea; fatigue; confusion; headache; lightheadedness; and tachycardia. "In addition, we are adding warning statements to more clearly identify the risks and symptoms presented by methemoglobinemia, a rare but serious condition associated with the use of benzocaine".

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