FDA criticized for language to consumers about teething medications

The Consumer Healthcare Products Association (CHPA) criticized the Food and Drug Administration (FDA) for confusing consumers about using products containing mild anesthetics for teething pain.

Jun 27th, 2014
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The Consumer Healthcare Products Association (CHPA) criticized the Food and Drug Administration (FDA) for confusing consumers about using products containing mild anesthetics for teething pain.

On June 26, the FDA announced that it was requiring a “boxed warning” to be added to the products’ labels. In May, the agency issued a consumer advisory titled, “Benzocaine and Babies: Not a Good Mix.”

CHPA, a trade association representing manufacturers of over-the-counter medications, took exception to the consumer advistory. In a June 27 statement, the association said the FDA did a “disservice to parents and caregivers,” creating “confusion among consumers and healthcare providers.”

The entire CHPA statement read:

“Today’s suggestion from FDA regarding benzocaine does a disservice to parents and caregivers who use FDA-approved OTC gel and liquid medicines containing benzocaine to treat their children suffering from teething pain. Consumer updates are not the appropriate means to alter the indicated use for FDA-approved medicines, and this suggestion creates confusion among consumers and healthcare providers as well. In 2012, FDA advised parents and caregivers not use benzocaine products for children younger than 2 years, unless under the advice and supervision of a healthcare professional. They provided no data as to why they changed the recommendation.

“OTC oral and liquid medicines containing benzocaine provide relief for children and adults who experience mouth pain. Consumers should continue to have confidence that these medicines can be used safely and appropriately by following the label. FDA needs to make their position clear through the regulatory process. We urge FDA to clarify its position to consumers and follow the appropriate regulatory path."

The FDA’s announcement regarding the warning said, “Oral viscous lidocaine solution is not approved to treat teething pain, and use in infants and young children can cause serious harm, including death.”

Health-care professionals were specifically advised not to prescribe or recommend products such as Anbesol, Hurricaine, Orajel, Baby Orajel, and Orabase. The agency also stated to manufacturers: “In addition to the Boxed Warning, we are requiring revisions to the Warnings and Dosage and Administration sections of the drug label to describe the risk of severe adverse events and to include additional instructions for dosing when the drug is prescribed for approved uses.”

All of the FDA actions were based on a review of 22 cases of children experiencing adverse reactions, including some deaths.

The agency’s consumer update, though,identified the products by brand names and said it was “particularly concerned” about parents using the products in the home care setting. The FDA urged restraint against using the products unless under the “advice and supervision of a health-care professional.”

The FDA’s long-term investigation of the products centers on the occurrence of methemoglobinemia in children who were treated with the mild anesthetic for teething pain.

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