Published: Fri, May 25, 2018
Medical | By Vicki Mclaughlin

FDA Warns Against Using OTC Benzocaine Teething Products

FDA Warns Against Using OTC Benzocaine Teething Products

The Food and Drug Administration is warning that some popular teething remedies for babies and toddlers can be harmful.

FDA is asking manufacturers to stop selling products for young children containing the medication. Health Canada says the pain reliever can cause a rare but serious blood condition called methemoglobinemia (MHb), which causes breathing problems and can lead to death.

The FDA said it will take legal action against companies that don't voluntarily remove their products for young children. Pharmacists should advise patients experiencing any of these symptoms to seek emergency medical attention.

The agency has warned parents about certain teething products in the past.

Regulators have issued multiple warnings about benzocaine but deaths have continued.

Benzocaine is found in gels, sprays and lozenges for teething, canker sores, sore throats and toothaches, for both adults and children.

Out of 119 cases reviewed in detail, mostly involving adults (with the benzocaine-containing product most commonly used during transesophageal echocardiography), 36 reported methemoglobinemia levels of 30% to 55% - a normal level ranges from 1% to 2%.

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The FDA is requiring manufacturers of all FDA-approved prescription local anesthetics to standardize warning information about the risk of methemoglobinemia in product labeling across this class of products. In addition to our letters to companies who make these products, we urge parents, caregivers and retailers who sell them to heed our warnings and not use over-the-counter products containing benzocaine for teething pain.

Wednesday's action comes more than four years after the consumer advocacy group Public Citizen petitioned the FDA to stop sales of teething products.

They also warn against using homeopathic alternatives.

Dr. Lisa Thebner, a New York-based pediatrician, said parents still ask about the products with some frequency.

The traditional recommendation of a gentle massage with your fingers on your child's gums is the go-to treatment.

When buying OTC oral health drug products, consumers should refer to the OTC Drug Facts Label to see if benzocaine is an active ingredient and, if using these products, look for signs and symptoms of methemoglobinemia.

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