The FDA has warned companies of legal action if these products are not removed from the market and their sales are not stopped for babies.
Various gels containing the numbing drug benzocaine can cause rare, but potentially fatal side effects in children, especially those younger than 2, according to The Associated Press. "We will also continue working with Congress to modernize our over-the-counter drug monograph regulatory framework as part of our mission to protect and promote public health".
Benzocaine is associated with a risky health condition called methemoglobinemia, that results in decreased oxygen in the blood - and that could lead to death.
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Benzocaine can trigger methemoglobinemia, a condition caused by elevated levels of a form of hemoglobin called methemoglobin. A study comparing the relative ability of benzocaine and lidocaine to make methemoglobin showed that benzocaine generated much more methemoglobin than lidocaine in a red blood cell model. Now it says there's little evidence these products actually work.
The Food and Drug Administration advises parents to stop using Orajel and other products marketed for teething babies containing benzocaine. "As part of the action, the agency is also requiring that prescription local anesthetics add updated warnings about their risk of this condition".
Some safe options include rubber teething products, a cold, wet wash cloth, or parents rubbing the baby's gums with a clean finger.
In addition to warning consumers this week, the FDA sent a letter (pdf) to companies that sell these products, request that they discontinue any lines marketed for teething relief.
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The White House has not commented on the case, and the Justice Department is reviewing its options, which could include an appeal. She also rejected the suggestion that since Twitter is a private company it is beyond the reach of First Amendment forum rules.
Benzocaine exists in products like Orajel and Anbesol, which treat mouth sores in adults.
Symptoms of methemoglobinemia may begin within minutes and up to two hours after the first use of benzocaine. Signs of methemoglobinemia include shortness of breath, fatigue, and pale, gray, or blue-colored skin, lips and nail beds. Babies who experience these problems should get medical attention immediately. But one thing you should not do is use over-the-counter gum-numbing medications containing benzocaine.
Benzocaine is not the only teething product the FDA has warned against.
In a press release, the FDA claimed it was committed to protecting Americans from serious risks connected to certain products.
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