From Medscape Education Clinical Briefs
Emma Hitt, Yael Waknine
December 22, 2010 — Accidental ingestion of benzonatate (Tessalon) by children younger than 10 years can result in serious adverse effects or death, the US Food and Drug Administration (FDA) announced.
Benzonatate, a round, liquid-filled gelatin capsule, is approved for symptomatic relief of cough in children older than 10 years but may represent a danger to younger children because of its candy-like appearance.
"The FDA encourages healthcare professionals to talk with their patients and those caring for children about the risk of accidental ingestion or overdose," Carol Holquist, RPh, director of the FDA's Division of Medication Error Prevention and Analysis, said in a news release. "Benzonatate should be kept in a child-resistant container and stored out of reach of children," she added.
Adverse events associated with ingestion of benzonatate include restlessness, tremors, convulsions, coma, and cardiac arrest, according to an alert sent today by MedWatch, the FDA's safety information and adverse event reporting program. Signs and symptoms of overdose can occur within 15 to 20 minutes of ingestion. Deaths reported in children have occurred within hours of accidental ingestion.
The FDA's Adverse Event Reporting System database identified 31 cases of overdose associated with benzonatate (median age, 18 years; range 1 - 66 years) between 1982 and May 2010.
Of those 31 cases, 7 cases of accidental ingestion were associated with benzonatate in children younger than 10 years. Of those 7 cases, 5 ingestions of as little as 1 capsule resulted in death in children younger than 3 years. Two patients, aged 12 months and 4 years, were hospitalized because of accidental benzonatate ingestion but survived.
"The safety and effectiveness of benzonatate in children younger than 10 years has not been established," according to the FDA news release.
The FDA is also adding a new Warning and Precaution section to the benzonatate drug label to warn healthcare professionals about accidental ingestion resulting in overdose and death in children younger than 10 years.
Additional Safety Tips
* Benzonatate capsules should be kept in a child-resistant container and stored out of sight and reach of children at all times. Medication should never be referred to as candy.
* Be aware that signs and symptoms of benzonatate overdose can occur within 15 to 20 minutes of ingestion and include restlessness, tremors, convulsions, coma, and cardiac arrest.
* Benzonatate capsules should be swallowed whole and not broken, chewed, dissolved, or crushed. Excessive absorption of the local anesthetic in oral mucosa can cause numbing of the mouth and throat, posing a choking hazard.
* If numbness or tingling of the mouth, tongue, throat, or face occurs, eating and drinking should be avoided until the condition resolves. Medical attention should be sought if symptoms persist or worsen.
* Benzonatate overdose has been reported in adults and adolescents. Patients should be aware that the maximum dose to be taken at any one time is 200 mg and the total daily dose should not exceed 600 mg. Missed doses should be skipped and the next dose taken as scheduled.
* Patients and caregivers should properly dispose of unneeded or expired medication by making it less appealing to children and pets (eg, mixing the medication with coffee grounds/kitty litter) and unrecognizable to others with access to trash. To prevent unintentional spillage from garbage bags, a sealable bag, empty can with tight lid, or other container should be used.
Healthcare professionals should advise parents and caretakers to call the Poison Control Center at 1-800-222-1222 and to seek medical attention immediately if a child accidentally ingests benzonatate.
More information about this warning can be found on the FDA Web site.
* Benzonatate is marketed as a round, liquid-filled gelatin capsule that resembles candy, potentially leading to accidental ingestion by children younger than 10 years. Overdose symptoms can occur within 15 to 20 minutes and include restlessness, tremors, convulsions, coma, and cardiac arrest; death has been reported within hours.
* Benzonatate capsules are indicated for symptomatic cough relief in patients older than 10 years. The pills must be swallowed whole and not broken, chewed, dissolved, or crushed. No more than 200 mg benzonatate should be taken at any 1 time, and the maximum daily dose is 600 mg; missed doses should be skipped. In the event of oral, throat, or facial numbness, food and drink should be avoided until symptoms resolve.
* Benzonatate capsules should be kept in child-resistant containers out of sight and reach of children. Unneeded or expired medication should be disposed of in a manner that renders it unappealing and unrecognizable to children, pets, and those with access to trash.