FDA: Benzonatate Deadly To Children Under 10

The U.S. Food and Drug Administration is warning the public that accidental ingestion of benzonatate 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 – a round-shaped liquid-filled gelatin capsule.

All accidental ingestions reported to FDA to date occurred in children less than 10 years of age. 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.

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.

The FDA offers this advice for patients and caregivers:

• Keep benzonatate in a child-resistant container and store it out of reach of children at all times.
• If a child accidentally ingests benzonatate, call the Poison Control Center (1-800-222-1222) and 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.
• Benzonatate capsules are to be swallowed whole and are not to be broken, chewed, dissolved, or crushed. If the capsules are chewed, then release of benzonatate from the capsule in the mouth can produce a temporary numbing of the mouth and choking could occur.
• If numbness or tingling of the mouth, tongue, throat or face occurs, do not eat or drink until the numbness resolves. If the symptoms worsen or persist, seek medical attention.
• Overdose of benzonatate has been reported in adults and adolescents. If you miss a dose of benzonatate, skip that dose and take the next dose at the next scheduled time.
• Do not take more than 200 mg of benzonatate at one time.
• Patients and caregivers should dispose of any leftover benzonatate in their household trash
• Take the medication out of its original container and mix it with an undesirable substance, such as used coffee grounds or kitty litter. The medication will be less appealing to children and pets, and unrecognizable to people who may intentionally go through your trash.
• Put the medication in a sealable bag, empty can with a tight lid, or other container to prevent it from breaking out of a garbage bag.
• Report any side effects or medication errors from the use of benzonatate to the FDA MedWatch program.