Benzocaine Lawsuit Filed Over FDA Failure to Address Infant Teething Risks

The consumer watchdog group Public Citizen has filed a lawsuit against the U.S. Food and Drug Administration (FDA), after the agency failed to act on a petition to limit the use of benzocaine, particularly in infant teething products that have been linked to serious health risks. 

The group filed the complaint (PDF) in federal court in the U.S. District Court for the District of Columbia on Thursday, seeking declaratory and injunctive relief over the agency’s failure to address benzocaine side effects, which have been linked to a potentially life-threatening blood disorder that impairs the body’s ability to use oxygen.

The original petition (PDF) was filed by Public Citizen in July 2014, calling for the FDA to ban over-the-counter benzocaine products marketed as teething products for infants and toddlers.

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“Although more than three years have passed since Public Citizen filed its petition, the FDA has neither granted nor denied it. Nor has the FDA taken any of the actions that Public Citizen requested to address serious health risks,” the lawsuit states. “Therefore, to protect public safety and prevent needless death and injury, Public Citizen seeks a declaration that the FDA has acted unlawfully by withholding action on Public Citizen’s petition and an order requiring the FDA to act on its petition.”

Benzocaine gels and liquids are commonly used by parents to help babies suffering from teething pain. However, use of the products in children under the age of two has been linked to a particularly high risk of developing a condition known as methemoglobinemia, in which the amount of oxygen carried through the blood stream is reduced.

The FDA first warned about the problems with benzocaine products in 2006, and updated that warning in 2012. At the time of the second warning, at least 29 cases of methemoglobinemia have been linked to benzocaine gel. At least 19 of those cases involved children, and 15 were children under the age of 2.

Public Citizen’s petition called for the agency to no longer allow benzocaine products to be sold for infant teething use, and for other benzocaine over-the-counter products to carry updated label warnings about the health risks.

In February 2016, the FDA sent Public Citizen an update on the petition, saying that it has been unable to reach a decision on what actions to take because it raised “significant/complex issues requiring extensive review and analysis by Agency officials.”

Public Citizen’s lawsuit argues that the FDA has had long enough to come to a decision, noting that the agency has issued multiple safety warnings, and there have been a number of medical and scientific studies further verifying the risks to children.

“The FDA concluded several years ago that over-the-counter benzocaine products should generally not be used to treat teething pain in infants. They are ineffective for this use and can cause a rare, but potentially deadly, adverse reaction,” Dr. Michael Carome, director of Public Citizen’s Health Research Group, said in a press release. “It is unconscionable that the agency has failed to take the regulatory actions necessary to address the health risks.”


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