FDA Warning: Store Benzonatate Properly to Avoid Potentially Fatal Ingestion by Children

December 22, 2010 2:11 PM

Food and Drug Administration (FDA) has issued a Drug Safety Communication warning patients and health care providers that ingestion of benzonatate, a drug used for relief of cough, by children under the age of 10 years can result in death from overdose. Benzonatate, also sold under the brand-name Tessalon and in generic preparations, may be attractive to children because of the drug's appearance. FDA reports that signs and symptoms of overdose can occur rapidly after ingestion (within 15-20 minutes) and that deaths in children have been reported within hours of the accidental ingestion. Further, overdose with benzonatate in children less than two years of age has been reported following accidental ingestion of as few as one or two capsules. FDA recommends that patients who are taking benzonatate keep the medication in a child-resistant container and store it out of reach of children. If a child accidentally ingests benzonatate, seek medical attention immediately. Signs and symptoms of benzonatate overdose may include restlessness, tremors, convulsions, coma, and cardiac arrest.