麻豆传媒

WASHINGTON -- Topical viscous lidocaine should not be used to treat infants' teething pain, the FDA said Thursday, emphasizing that teething pain needs no medicinal treatment.

A new boxed warning will be added to labels for 2% oral viscous lidocaine products, which are available by prescription, indicating that such use "can cause serious harm, including death," .

The warning emerged from a review of 22 adverse event reports submitted to the FDA through December 2013, including six fatalities and 11 hospital admissions. Only five of the 22 reports explicitly indicated that the products were used for teething pain, but the FDA concluded that the risk would be present for that indication as well as others.

Oral use of these products typically leads to ingestion that cannot be predicted or controlled. In excessive amounts, ingested lidocaine can induce seizures, brain injury, and/or cardiac abnormalities, the agency said.

Other data indicated that use of oral viscous lidocaine in infants is not uncommon, with approximately 40,000 prescriptions written annually from 2008 to 2012.

The new warning for viscous lidocaine follows a similar admonition issued by the FDA in 2012 on over-the-counter benzocaine products related to risk of methemoglobinemia.

When an infant shows pain or discomfort because of teething, parents should simply massage the gum with a finger or let the infant chew on a cooled teething ring or damp cloth, the FDA said in a .

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