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news.The US Food and Drug Administration (FDA) has issued a warning that accidental ingestion of Tessalon (benzonatate) liquid cough capsules by children younger than 10 years can lead to serious side-effects or death.
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Tessalon, an FDA approved drug to treat symptomatic relief of cough in patients older than 10, may attract younger children as the drug has a candy-like appearance – a round, liquid-filled gelatin capsule.
The safety and effectiveness of benzonatate in children younger than 10 has not been established.
FDA Division of Medication Error Prevention and Analysis director Carol Holquist said Benzonatate should be kept in a child-resistant container and stored out of reach of children.
"The FDA encourages health care professionals to talk with their patients and those caring for children about the risk of accidental ingestion or overdose," Holquist said.
According to the FDA, a review of the Adverse Event Reporting System database from 1982 through May 2010 revealed seven cases of accidental ingestion associated with benzonatate in children younger than 10.
Common adverse events reported in the overdose cases included cardiac arrest, coma and convulsion.