FDA Demands Orajel to Soothe Teething Babies Be Taken Off Market

25 May, 2018, 20:59 | Author: Veronica Peterson
  • The American Academy of Pediatrics recommends giving babies teething rings or simply massaging their gums to relieve pain

FDA officials are requesting that these products no longer be marketed or sold - or, at the least, that companies add warnings with up to date drug safety information to all oral health products containing benzocaine.

The agency "is asking companies to stop selling these products for such use", according to a statement posted on the FDA website. If they do not comply, the FDA says it will "will initiate a regulatory action to remove these products from the market".

Regulators already released warnings about the dangers of benzocaine, but deaths remained a problem.

Benzocaine is associated with a unsafe health condition called methemoglobinemia, which causes the amount of oxygen carried through the blood to be greatly reduced. The painkiller can be found in Baby Orajel, a gel that can be spread over the gums, as well as in other sprays, gels, and lozenges.

Officials say if you or your child show any symptoms, which include weakness, confusion, headache, difficulty breathing and/or pale-, grey- or blue-coloured skin, you should go see a health practitioner immediately.

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"The FDA is committed to protecting the American public from products that pose serious safety risks, especially those with no demonstrated benefit", said FDA Commissioner Scott Gottlieb, M.D. More than 400 cases have been reported to the FDA or appear in the medical literature, the agency said in a data summary. Medications are usually ineffective "because they wash out of the baby's mouth within minutes", the agency said.

For treatment of teething pain, the American Academy of Pediatrics recommends using teething rings made of firm rubber (not frozen), or gently rubbing or massaging the child's gums with a finger.

It's also not the first teething product that the FDA has cautioned against. The FDA also previously cautioned parents and caregivers to not give certain homeopathic teething tablets to children and to seek advice from their health care professional for safe alternatives.

New Jersey-based manufacturer Church and Dwight Co.

The US Food and Drug Administration is warning parents about potentially deadly risks of teething remedies that contain a numbing ingredient used in popular brands like Orajel. 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.


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