FDA warns against safety risks of teething pain relievers

The U.S. Food and Drug Administration issued a warning and alerted parents, caregivers and health care providers against the safety risks of various devices used for relieving teething pain pose for children. The agency warned that they should not be used to relieve teething pain in children or to provide sensory stimulation to persons with special needs, such as autism or attention-deficit/hyperactivity disorder (ADHD).

A number of reports have been received by FDA about death and serious injuries to infants and children, including strangulation and choking, caused by teething jewelry, such as amber teething necklaces.

The risks of using jewelry for relieving teething pain include choking, strangulation, injury to the mouth and infection. Choking can happen if the jewelry breaks and a small bead enters the child’s throat or airway. Strangulation can occur if a necklace is wrapped too tightly around the child’s neck or if the necklace catches an object such as a crib. Other concerns include injury to the mouth or infection if a piece of the jewelry irritates or pierces the child’s gums. In addition to choking and strangulation concerns, amber teething necklaces contain a substance called succinic acid, which allegedly may be released into an infant’s bloodstream in unknown quantities. Manufacturers of these products often claim succinic acid acts as an anti-inflammatory and relieves teething and joint pain. The FDA has not evaluated these claims for safety or effectiveness and recommends parents not use these products.

Teething jewelry can come in various forms, including a necklace, bracelet or anklet, and can be worn by either an adult or child. Such products are produced and sold by a large number of manufacturers and individuals. They are often used by parents and caregivers to relieve infants’ teething pain and other ailments. Teething jewelry may also be used by people with special needs, such as autism or ADHD, to provide sensory stimulation or redirect chewing on clothes or body parts. The beads of the jewelry may be made with various materials such as amber, wood, marble or silicone.

“We know that teething necklaces and jewelry products have become increasingly popular among parents and caregivers who want to provide relief for children’s teething pain and sensory stimulation for children with special needs. We’re concerned about the risks we’ve observed with these products and want parents to be aware that teething jewelry puts children, including those with special needs, at risk of serious injury and death,” said FDA Commissioner Scott Gottlieb, M.D. “Consumers should consider following the American Academy of Pediatrics’ recommendations of alternative ways for treating teething pain, such as rubbing inflamed gums with a clean finger or using a teething ring made of firm rubber. Given the breadth of the market for these teething necklaces and jewelry, we’re sharing this important safety information directly to consumers in order to help prevent injuries in infants and kids.”

The FDA issued a safety communication after receiving a small number of medical device reports, including one death. One report involved a 7-month old child who choked on the beads of a wooden teething bracelet while under parental supervision and was taken to the hospital, and another involved an 18-month old child who was strangled to death by his amber teething necklace during a nap.

In addition to avoiding using jewelry to relieve teething pain, the FDA continues to recommend that caregivers avoid using teething creams, benzocaine gels, sprays, ointments, solutions and lozenges for mouth and gum pain. Benzocaine and other local anesthetics can cause methemoglobinemia, a serious condition in which the amount of oxygen carried through the blood is reduced. This condition is life-threatening and can result in death.

The FDA will continue to closely monitor adverse event reports associated with jewelry used for relieving teething pain and will communicate further as warranted.