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FDA Warns that Benzocaine and Babies are Not a Good Mix

June 5, 2012 — The U.S. Food and Drug Administration (FDA) is again warning parents about the dangers of using teething gels containing benzocaine. This drug is a painkiller found in products such as Anbesol, Hurricaine, Orajel, Baby Orajel, and Orabase. Children under 2 years old who are given these products may develop methemoglobinemia, which can be fatal. The FDA has received a total of 29 reports of methemoglobinemia linked to benzocaine oral pain relievers — 19 of which occurred in children.

The FDA is recommending that parents and caregivers should not give benzocaine products to children under two years old, except under the direct guidance and supervision of a physician.

Methemoglobinemia is a disorder that occurs when the blood produces too much methemoglobin (a type of hemoglobin, which is the molecule in red blood cells that transports oxygen). Because hemoglobin cannot release the oxygen it carries, the tissues become oxygen-deprived.

Symptoms of methemoglobinemia include the following:

  • Pale gray/bluish color to the skin, lips, nails
  • Shortness of breath
  • Fatigue
  • Confusion
  • Headache
  • Light-headedness
  • Rapid heart rate

The FDA is warning that these symptoms may appear in children given their first dose of benzocaine, but also in children who have taken benzocaine safely in the past. If a child has any of the above symptoms after taking benzocaine, parents are advised to stop using the product and call 911 immediately.

If untreated, methemoglobinemia can cause permanent brain damage, tissue damage, and even death.

Instead of using benzocaine teething gel products, the FDA is advising that parents use other methods to soothe a teething baby. This may involve a teething ring that has been chilled in the refrigerator, or gently rubbing the baby’s gums with your finger.

Although benzocaine poses the greatest risk to children, the FDA is also warning that they can cause adverse events in adults. Therefore, they advise using the products sparingly, and never more than 4 times per day. Furthermore, talk to your doctor about the safety of this product if you are a smoker, have heart disease, breathing problems, asthma, bronchitis, or emphysema.

Do I have a Benzocaine Lawsuit?

The Schmidt Firm, PLLC is currently accepting benzocaine induced injury cases in all 50 states. If you or somebody you know has been injured by benzocaine or baby teething gel products, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Benzocaine Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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