Consumers are being warned that some over-the-counter teething products for babies can pose a serious risk.
The Food and Drug Administration announced Wednesday the oral health products for infants containing the pain reliever benzocaine for the temporary relief of sore gums should not be marketed or sold.
"If companies do not comply, the FDA will initiate a regulatory action to remove these products from the market. Also, the agency is requesting that companies add new warnings to all other benzocaine oral health products to describe certain serious risks," the FDA message says.
Products with benzocaine post "serious safety risks," the FDA says. They also show no real demonstrated benefit.
" ... 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. In addition to our letters to companies who make these products, we urge parents, caregivers and retailers who sell them to heed our warnings and not use over-the-counter products containing benzocaine for teething pain.
"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," the FDA says.