FDA warns teething medicines unsafe

Ebony Scott
May 25, 2018

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 on Wednesday said it wants manufacturers to stop selling products intended for babies and toddlers because the products contain a drug ingredient that can cause a rare but unsafe blood condition that interferes with normal breathing.

The agency said it will take action against companies that don't voluntarily remove benzocaine products for young children.

The FDA added that the agency has been warning against using OTC teething medications for the last decade, however infant deaths linked to benzocaine continue to be reported. The latest target? Children's gel teething products that contain the painkiller benzocaine.

Benzocaine is associated with a risky health condition called methemoglobinemia, that results in decreased oxygen in the blood - and that could lead to death.

FDA commissioner Scott Gottlieb said in a release there are "no demonstrated benefits" from the benzocaine products. Now it says there's little evidence these products actually work.

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On the American Academy of Pediatrics site, HealtyChildren.org, the page on teething babies has a warning that reads, "Stay away from teething tablets that contain the plant poison belladonna and gels with benzocaine".

As an alternative they write, "Try gently rubbing or massaging the gums with one of your fingers".

Generally, these products are used by the parents to lessen their child's teething pain.

Federal officials are warning parents about the potential dangers of teething medicines. They say using these products can lead to a serious and sometimes fatal condition. These include pale, gray- or blue-colored skin, lips and nail beds; shortness of breath; fatigue; headache; lightheadedness; and rapid heart rate.

In response to the FDA's warning, Church and Dwight Co. Oral products for adults to treat sore throats, canker sores and irritation of the mouth and gums can also contain benzocaine.

Symptoms of methemoglobinemia may begin within minutes and up to two hours after the first use of benzocaine.

Other reports by GizPress

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