FDA takes action against benzocaine in the US

FDA takes action against benzocaine in the US
The US Food and Drug Administration (FDA) is committed to protecting the American public from products that pose serious safety risks, especially those with no demonstrated benefit, says FDA commissioner Scott Gottlieb

24 May 2018 - Deborah Wilkes

The US Food and Drug Administration (FDA) is urging consumers not to use OTC teething products containing benzocaine because they "pose a serious risk" to infants and children younger than two years.

The regulatory agency has written to companies asking them to stop selling the products. If companies do not comply, the FDA will take regulatory action to remove the products from the market.

The FDA has also asked companies to add new warnings to all other benzocaine-containing oral health products for adults and children aged two years and older as well as to prescription local anaesthetics containing benzocaine.

Consumer rights group Public Citizen

Consumer rights group Public Citizen said the FDA’s action to "protect infants from a serious blood disorder caused by OTC benzocaine teething products is long overdue".

Public Citizen insisted that the FDA must move swiftly to ensure that companies cease marketing oral health products containing benzocaine for the temporary relief of teething pain in infants or children.

The FDA's action comes six months after Public Citizen said it was suing the regulatory agency over its "failure to take action" on a petition about safety issues associated with benzocaine.

Public Citizen petitioned the FDA in July 2014 about OTC oral health products containing benzocaine. The consumer rights group pointed out that benzocaine was linked with methemoglobinemia, a life-threatening blood disorder that impairs the body's ability to use oxygen.

Benzocaine products were too dangerous for teething products, maintained Public Citizen, adding that warning labels were needed on similar products intended for use in older children and adults.

Commenting on the action against benzocaine, the FDA's commissioner Scott Gottlieb said the regulatory agency was "committed to protecting the American public from products that pose serious safety risks, especially those with no demonstrated benefit".

Lack of efficacy for teething

"Because of the lack of efficacy for teething and the serious safety concerns we have seen with OTC benzocaine oral health products," added Gottlieb, "the FDA is taking steps to stop use of these products in young children and raise awareness of the risks associated with other uses of benzocaine oral health products."

"We urge parents, caregivers and retailers who sell these products to heed our warnings and not use OTC products containing benzocaine for teething pain," said Gottlieb.

The FDA said it would continue to monitor the safety and effectiveness of OTC benzocaine products and would take additional action in the future as needed.

Benzocaine is marketed to help relieve pain from a variety of conditions such as teething, sore throat, canker sores and irritation of the mouth and gums. The products are sold as gels, sprays, ointments, solutions and lozenges under the OTC brand names Anbesol, Baby Orajel, Cepacol, Chloraseptic, Hurricaine, Orabase, Orajel and Topex, as well as store brands and generics.

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