ibusinesslines.com August 17, 2018

FDA urges parents to stop using numbing medicines on teething babies' gums

25 May 2018, 09:00 | Melissa Porter

The American Academy of Pediatrics recommends giving babies teething rings or simply massaging their gums to relieve pain

The American Academy of Pediatrics recommends giving babies teething rings or simply massaging their gums to relieve pain

The FDA warned about the potential dangers of benzocaine in 2006 and 2011, and has said parents shouldn't use the products in children younger than 2.

The agency "is asking companies to stop selling these products for such use", according to a statement posted on the FDA website. The ultimate objective here is to discontinue these treatments' marketing altogether; if companies don't play ball, "the FDA 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.

In rare cases, it can affect how the red blood cells carry oxygen. The over-the-counter medicines have brand names Anbesol, Baby Orajel, Cepacol, Chloraseptic, Hurricaine, Orabase, Orajel and Topex, as well as store brands and generics.

Church & Dwight Co., which sells and markets Orajel products for teething, said in a statement that the safety of its customers and their children is its highest priority, and it is immediately discontinuing the distribution and sale of Orajel teething products containing benzocaine. Symptoms include rapid heart rate, lightheadedness, difficulty breathing, sleepiness, headache, skin that is pale and nails that are blue or gray.

"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. Medications are usually ineffective "because they wash out of the baby's mouth within minutes", the agency said.

The FDA also says it can be unsafe. It's better to give your child a rubber teething ring or a gentle finger massage (frozen toys have been known to also cause oral injuries).

In January 2017, the FDA warned against homeopathic teething tablets after finding "inconsistent amounts of belladonna" that sometimes far exceeded the amounts indicated on the label.

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.

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

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