The U.S. Food and Drug Administration (FDA) has issued a warning to the public that accidental ingestion of benzonatate (Tessalon) by children under the age of 10 years can result in death from overdose.
Benzonatate is a prescription drug approved for relief of cough in patients over 10 years of age. The safety and effectiveness of benzonatate in children under 10 years of age have not been established. Benzonatate is sold under the brand-name Tessalon and is also sold in generic preparations.
Benzonatate may be attractive to children because of the drug's appearance (it is a round-shaped liquid-filled gelatin capsule).
Overdose with benzonatate in children less than 2 years of age has been reported following accidental ingestion of as few as 1 or 2 capsules. Individuals who experience overdose of benzonatate may exhibit restlessness, tremors, convulsions, coma, and cardiac arrest. Signs and symptoms of overdose can occur rapidly after ingestion (within 15-20 minutes). Deaths in children have been reported within hours of the accidental ingestion.
The FDA has issued guidelines for the healthcare professionals and patients.
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