FDA Warns Teething Gel Ingredient Linked To Potentially Fatal Condition

[MuffyBee]

http://www.clickondetroit.com/health/27481846/detail.html
FDA Warns Teething Gel Ingredient Linked To Potentially Fatal Condition
April 8, 2011

The Food and Drug Administration is warning the public that benzocaine, the main ingredient in over-the-counter gels and liquids used to reduce mouth and gum pain, is associated with a rare, but potentially fatal condition.

This condition is called methemoglobinemia. It causes the amount of oxygen carried through the blood stream to be greatly reduced. In the most severe cases, it can result in death.

The FDA said benzocaine gels and liquids are sold under different brand names such as Anbesol, Hurricaine, Orajel, Baby Orajel, Orabase and store brands.

The agency said the cases of methemoglobinemia occurred mainly in children age 2 or younger who were treated with benzocaine gel for teething.
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[MuffyBee]

http://www.fda.gov/Drugs/DrugSafety/ucm250024.htm
FDA Drug Safety Communication: Reports of a rare, but serious and potentially fatal adverse effect with the use of over-the-counter (OTC) benzocaine gels and liquids applied to the gums or mouth
Safety Announcement

[04-07-2011] The U.S. Food and Drug Administration (FDA) is warning the public that the use of benzocaine, the main ingredient in over-the-counter (OTC) gels and liquids applied to the gums or mouth to reduce pain, is associated with a rare, but serious condition. This condition is called methemoglobinemia and results in the amount of oxygen carried through the blood stream being greatly reduced. In the most severe cases, methemoglobinemia can result in death.

Benzocaine gels and liquids are sold OTC under different brand names such as Anbesol, Hurricaine, Orajel, Baby Orajel, Orabase, and store brands. Benzocaine is also sold in other forms such as lozenges and spray solutions (also see separate Drug Safety Communication on Benzocaine Sprays1). These products are used to relieve pain from a variety of conditions, such as teething, canker sores, and irritation of the mouth and gums.

Methemoglobinemia has been reported with all strengths of benzocaine gels and liquids, including concentrations as low as 7.5%. The cases occurred mainly in children aged two years or younger who were treated with benzocaine gel for teething. People who develop methemoglobinemia may experience pale, gray or blue colored skin, lips, and nail beds; shortness of breath; fatigue; confusion; headache; lightheadedness; and rapid heart rate.  In some cases, symptoms of methemoglobinemia may not always be evident or attributed to the condition. The signs and symptoms usually appear within minutes to hours of applying benzocaine and may occur with the first application of benzocaine or after additional use. If you or your child has any of these symptoms after taking benzocaine, seek medical attention immediately.
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