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Teething Medications Linked to Blood Disorder, FDA Warns

May 6, 2011 | Parker Waichman LLP

Parents who use products such as Anbesol, Hurricaine, Orajel, Baby Orajel, and Orabase, have been warned that the active ingredient in such products - benzocaine - has been associated with a serious side effect called methemoglobinemia.  This rare blood condition can be life threatening.

Unfortunately, labels for benzocaine sprays and gels do not currently contain a warning about their association with methemoglobinemia.

Methemoglobinemia seriously reduces the amount of oxygen carried through the bloodstream.  According to a warning issued last month by the U.S. Food & Drug Administration (FDA), methemoglobinemia has been reported with all strengths of benzocaine gels and liquids.  Most reported cases of methemoglobinemia have occurred in children ages 2 and under who were treated with benzocaine products for teething pain.

The symptoms of methemoglobinemia can appear in minutes or hours following the application of a benzocaine product.  Often, the condition occurs after just one application of the medication.  Symptoms of methemoglobinemia may include a pale, bluish or grayish pallor, shortness of breath, fatigue, confusion, and lightheadedness, and rapid heart rate. If any of these symptoms occur, medical attention should be sought immediately.

The FDA has said that benzocaine medications should never be used in children under two.  Such products should only be used sparingly in adults, and not more than four times per day.

The FDA first issued a warning about benzocaine sprays and methemoglobinemia in 2006.  But since then, the agency said it has received reports of 72 new cases of methemoglobinemia, including three resulting in death, associated with the use of benzocaine sprays, bringing the total to 319 cases.

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