FDA Orders Benzocaine Teething Products Off Shelves For Deadly Methemoglobinemia Risk

Cute baby chewing on teething tablet

Cute baby chewing on teething tablet

Teething products with benzocaine include Baby Orajel.

The FDA said that benzocaine can have a rare, but serious side effect on children, and especially those under 2 years old. Specifically, regulators say that these benzocaine-containing products may be associated with a scary condition called methemoglobinemia, "the result of elevated levels of methemoglobin in the blood [which] can lead to death" by sharply reducing the amount of oxygen carried through the blood.

According to the American Academy of Pediatric Dentistry (AAPD), it is never too early to start brushing baby gums with a soft infant toothbrush (or just a cloth and water) every day. Rapid heart rate, headache, lightheadedness, difficulty in breathing, sleepiness, pale skin, and blue or gray eyes are some of the symptoms of methemoglobinemia.

FDA said it is acting now because of mounting evidence on benzocaine's dangers.

The FDA says benzocaine is a local anesthetic that is an active ingredient in several over the counter oral health care products. The FDA has warned companies of legal action if these products are not removed from the market and their sales are not stopped for babies.

The FDA said parents and caregivers should stop using the products and companies should stop selling them. Instead of relying on the medicine, the FDA suggests parents use a rubber teething ring, or gently massage the child's gums with a finger.

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Benzocaine, a local anesthetic agent is also found in over-the-counter products that are used for mouth sores, mouth ulcers, toothaches, cold sores etc.

The FDA's warning is an update to a statement the regulatory agency made seven years ago.

Signs and symptoms of methemoglobinemia may set in after using benzocaine for the first time, and could appear within minutes to 1 to 2 hours.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

Crying is the soundtrack of teething, as baby's new teeth break through. You try every type of chilled teething toy you can get your hands on to relieve the pain in your baby's gums.

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