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benzocaine (ORAJEL)

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    The Food and Drug Administration (FDA) agreed with Public Citizen that over-the-counter oral health care products containing benzocaine should never be used in infants under any circumstances, even with the advice and supervision of a health care professional, because of the risk of methemoglobinemia, a life-threatening blood disorder that impairs the body’s ability to use oxygen.
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    The FDA’s action today to protect infants and children from exposure to over-the-counter oral health products containing benzocaine, which can cause methemoglobinemia, a life-threatening blood disorder that impairs the body’s ability to use oxygen, comes too late for some infants and children.
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    Public Citizen petitions the Food and Drug Administration to no longer allow over-the-counter (OTC) benzocaine products to be marketed for treating teething in infants and toddlers because they can prompt a rare but deadly adverse reaction. In addition, the agency should require a warning about this adverse reaction on all other OTC benzocaine products intended for use in older children and adults.

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