FDA Warns Parents To Stop Giving Unsafe Teething Medicines to Children

May 25, 2018, 21:50
FDA Warns Parents To Stop Giving Unsafe Teething Medicines to Children

Consumer-health companies must stop selling products such as Baby Orajel to parents with teething infants, US health regulators said, given the risk of developing a potentially deadly condition that reduces oxygen levels in the blood. The latest target? Children's gel teething products that contain the painkiller benzocaine. Of particular concern is a rare but potentially life-threatening side effect benzocaine can have in babies and young children called methemoglobinemia, in which the amount of oxygen in a person's blood is reduced.

The agency says there is "accumulating evidence" that benzocaine is associated with methemoglobinemia, a risky blood condition that can lead to death.

The American Academy of Pediatrics does not recommend teething creams because they usually wash out of the baby's mouth within minutes. Symptoms include rapid heart rate, lightheadedness, difficulty breathing, sleepiness, headache, skin that is pale and nails that are blue or gray.

"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", said FDA Commissioner Scott Gottlieb in his statement. Benzocaine is a topical anesthetic used in teething ointments, gels, lozenges and sprays.

This is not the first warning about benzocaine from the FDA.

Regulators already released warnings about the dangers of benzocaine, but deaths remained a problem.

If manufacturers fail to comply, then the FDA will issue a regulatory action to remove these products from the market. They say using these products can lead to a serious and sometimes fatal condition.

Benzocaine, a local anesthetic agent is also found in over-the-counter products that are used for mouth sores, mouth ulcers, toothaches, cold sores etc.

The maker of Orajel said it would discontinue products for infant teething pain.

Some brands that have benzocaine includes brands like Baby Orajel, Anbesol and Topex. You try every type of chilled teething toy you can get your hands on to relieve the pain in your baby's gums.

Dr. Lisa Thebner, a New York-based pediatrician, said parents still ask about the products with some frequency. The FDA has been warning consumers about these products for years, and now it is taking more serious action.