FDA cracks down on benzocaine teething products

pharmafile | May 24, 2018 | News story | Sales and Marketing FDA, benzocaine, pharma, teething products 

The FDA has put its foot down on over-the-counter teething products for infants and children which contain benzocaine, a pain relieving agent which has been linked to serious health risks, stressing that they are ineffective and is calling for manufacturers to cease sale of such products.

Should manufacturers fail to comply to this request, the FDA has said it will initiate regulatory action to forcibly remove their products from the market. The agency has also asked companies to provide additional warnings on the risks of benzocaine to the labels of all other oral health products. Affected firms will have 30 days to respond to the new requirements.

“The FDA is committed to protecting the American public from products that pose serious safety risks, especially those with no demonstrated benefit,” said FDA Commissioner Scott Gottlieb. “Because of the lack of efficacy for teething and the serious safety concerns we’ve seen with over-the-counter benzocaine oral health products, 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 modernise our over-the-counter drug monograph regulatory framework as part of our mission to protect and promote public health.”

Benzocaine, which is found in a number of gels, sprays, ointments and lozenges such as Topex, Orajel and Anbesol, purports to relive pain when applied to the mouth and gums, and is marketed as a treatment for teething, canker sores and sore throat. The FDA has warned about the risks of such medication in the past, particularly due to their links to the development of methemoglobinemia, a dangerous and potentially fatal condition characterised by elevated levels of methemoglobin in the blood.

Matt Fellows

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