Candy-Like Cough Capsules May Pose Serious Risk to Young Children
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.
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