This week the FDA took a more firm approach to stopping the use of benzocaine-containing products in children. Long sold as topical medicines for mouth pain such as teething and canker sores, these medicines are also known to cause an uncommon condition called methemoglobinemia. In this condition, benzocaine reacts with the hemoglobin in a person’s red blood cells, preventing the uptake and transport of oxygen. Symptoms can include blue or gray appearance of the face/lips, fingers, and mucous membranes. As the blood can carry less oxygen, there is a risk of organ damage and suffocation. The reaction can be immediate or can occur within several hours of medication use and can occur even with a tiny dose, even in people who have used the product safely in the past.
The small chance of developing methemoglobinemia while using benzocaine has long been known, and many doctors for years have recommended against using these medicines, but the FDA announcement goes further, and likely will be the end of these products for pediatric patients. If a manufacturer continues to sell one of these products, the FDA states it would take “regulatory action”, but it is unlikely that anyone will continue making these products for pediatric use given the FDA’s clear and firm restriction. Commonly sold brands include Orajel, Anbesol, Cepacol, and Hurricaine, as well as private-label versions.
The FDA has also in the past recommended against the use of homeopathic teething medications being sold as benzocaine alternatives, as some had been found to contain small amounts of some ingredients (including belladonna) that can cause neurological, respiratory, and musculoskeletal system complications, including potentially seizures.
Instead of using teething medication, the AAP recommends using hard rubber chew toys for babies and toddlers to gnaw on. These can be kept cold (but not frozen) to help even more. Use of acetaminophen or ibuprofen is not recommended as teething can last for a prolonged period of time and these medicines are not meant for chronic use.
The new restriction is for children only. Adults can still use these products but likely there will need to be new safety warnings on the packaging.