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FDA: Benzonatate can cause serious side effects or death in children under 10 years

Accidental ingestion of the cough-suppressant benzonatate (Tessalon, Forest Pharmaceuticals) can result in serious side effects or death in children under 10 years, the FDA announced in a press release.

The drug is only approved in patients older than 10 years, but may attract younger children due to its candy-like appearance, according to the release. The safety and efficacy of benzonatate in children under 10 years has not been confirmed.

“Benzonatate should be kept in a child-resistant container and stored out of reach of children," said Carol Holquist, RPh, director of FDA’s Division of Medication Error Prevention and Analysis, in the release. “The FDA encourages health care professionals to talk with their patients and those caring for children about the risk of accidental ingestion or overdose.”

Several cases of accidental benzonatate ingestion between 1982 and 2010 were identified in the FDA’s Adverse Event Reporting System. Five cases resulted in death in children aged two years and under. Accidental ingestion of even one or two capsules was enough to trigger an overdose in children under two years, according to the release.

Adverse events include coma, convulsions and cardiac arrest. Some of the reported deaths occurred within hours of ingestion. Overdose signs and symptoms can occur within 15 to 20 minutes of ingestion, the release said.

The FDA is adding a new warming to benzonatate’s drug label. Health care professionals should report adverse side effects or medication errors to the FDA's MedWatch Adverse Event Reporting program at http://www.fda.gov/MedWatch or by calling 800-332-1088.

Disclosure: Dr. Holquist reports no relevant financial disclosures.

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