Tessalon (benzonatate) Warning of Potential Accidental Ingestion by Children

The FDA warns Pediatrics, Pharmacy healthcare personnel and patients that Tessalon (benzonatate) can result in death from overdose if it is accidentally ingested by children under the age of 10.

Background of Tessalon (benzonatate)

Benzonatate is sold under the brand-name Tessalon and in generic preparations.  The drug is used for the relief of cough in patients older than 10. Tessalon (benzonatate) is sold in a round-shaped liquid-filled gelatin capsule.

FDA Alert on Tessalon (benzonatate)

The FDA warns that overdose with benzonatate in children less than 2 years old has been reported as a result of accidental ingestion of 1or 2 capsules of the drug. Signs and symptoms of overdose may include tremors, coma and cardiac arrest occurring in a few minutes. Even death may occur within hours of the ingestion.

Recommendation on Tessalon (benzonatate)

“Patients who are taking benzonatate should 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 can occur rapidly after ingestion (within 15-20 minutes) and may include restlessness, tremors, convulsions, coma, and cardiac arrest.”

Contacting the FDA to report cases with Tessalon (benzonatate)

In case of detection of adverse events or side effects related to the use of Tessalon (benzonatate), healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to: 1-800-FDA-0178

AttorneyOne.com is a free nationwide legal referral service. We are not a law firm. We help consumers find the best representation for their legal needs.