FDA

FDA asks companies to stop selling oral anesthetics containing benzocaine for teething

Bloomberg News (5/23, Edney, 4.02M) reports the Food and Drug Administration asked companies “to voluntarily stop selling oral anesthetics that contain benzocaine to soothe teething pain,” because of “the risk of developing a potentially deadly condition that reduces oxygen levels in the blood.” The agency is also requesting all products containing the drug to warn customers “about infant use.” FDA Commissioner Scott Gottlieb said in a statement, “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.”

The AP (5/23, Perrone) reports FDA Commissioner Scott Gottlieb said in a statement, “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.” The article mentions that “the American Academy of Pediatrics does not recommend teething creams because they usually wash out of the baby’s mouth within minutes. Instead, the group recommends giving babies teething rings or simply massaging their gums to relieve pain.”

HealthDay (5/23, 5K) reports Dr. Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, said, “Given the accumulating evidence regarding benzocaine’s association with methemoglobinemia, we are taking necessary action to work with industry to discontinue the distribution and sale of over-the-counter benzocaine oral health products intended for teething pain.”

MedPage Today (5/23, Gever, 61K) reports the FDA said in a statement on its website, “If companies do not comply, the FDA will initiate a regulatory action to remove these products from the market.”

CNN (5/23, Christensen, 80.64M) reports on its website that the FDA also issued warnings in September 2016 against homeopathic teething tablets and gels.

Also covering the story are the New Orleans Times-Picayune (5/23, McKnight, 498K), the Connecticut Post (5/23, Cuda, 183K), and TIME.



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