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FDA Updates Benzocaine Warning, Following 29 Reports of Injuries, Many to Children

Jul 30, 2012 | Parker Waichman LLP

Federal health authorities are urging parents to not use products containing the ingredient benzocaine to allay a baby’s teething pains due to the risk of a potentially life-threatening side effect.

According to a HealthDay News report, the Food and Drug Administration warns that children 2 years old or younger face the highest, albeit small risk of developing methemoglobinemia, a condition that reduces the oxygen in the bloodstream.

As children develop through their early years and start teething, nearly everyone experiences severe oral pains in the gums and mouth. Distraught parents often turn to products containing the analgesic pain reliever benzocaine, partially because they are marketed for children in some instances. Over-the-counter products like Anbesol, Orajel, Baby Orajel, Orabase, and Hurricaine are just some of the leading consumer products available to treat mouth and gum pain. These topical products are largely believed to be safe and effective but the FDA warns that parents should avoid using them on younger children (under age 2) due to this serious risk factor.

Rather than using pain reliever products, health officials suggest using a teething ring chilled in the refrigerator or massaging the gums with a finger to relieve the pain.

This warning echoes an FDA advisory six years ago on the use of benzocaine among young children. In that time, the agency has received at least 29 reports of methemoglobinemia linked to their use. Among them, 19 children were affected by this little-known side effect and most of them were under the age of 2 when they were afflicted by it. The FDA has also received reports of three deaths caused by methemoglobinemia due to benzocaine.

At the same time, the FDA is urging parents to be on the lookout for signs of methemoglobinemia, including pale, gray, or blue-tinted skin, lips, and nail beds. A baby affected by methemoglobinemia may also experience shortness of breath, fatigue, and confusion, as well as headaches and light-headedness and an increased heart rate.

It could take just minutes or hours for these symptoms to present themselves and if they were to occur, parents should rush their child to a local emergency room to avoid further complications. As such, products containing benzocaine should only be administered by a health care professional and only when absolutely necessary, according to the FDA.

In addition to topical ointments and gels, benzocaine is also available in spray form in products like Cetacaine, Exactacain, and Topex. 

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