FDA warns that Tessalon Liquid Cough Capsules can Prove Fatal in Children

Tessalon (benzonatate) is an FDA-approved symptomatic cough relief drug for patients older than 10 years. However, this drug may attract younger children because of its candy-like appearance (round, liquid-filled gelatin capsule). The safety and effectiveness of benzonatate in children younger than 10 years has not been established. The FDA has therefore warned that accidental ingestion of Tessalon by children younger than 10 years can lead to serious side effects or even death.

Seven cases of accidental ingestion associated with benzonatate in children younger than 10 years were identified between 1982 and 2010. Five of the children died and they were up to two years old.  Accidental ingestion of just one or two capsules leading to an overdose of benzonatate in children younger than two years of age has been reported. Amongst adverse consequences, cardiac arrest, coma, and convulsion have been reported.  Signs and symptoms of overdose can occur within 15 or 20 minutes of ingestion.

The FDA is also adding a new Warning and Precaution section to the benzonatate drug label to warn health care professionals about accidental ingestion leading to overdose and death in children younger than 10.

Regulations

The Prescription Drug Marketing Act (PDMA) of 1987 is a U.S federal law. The U.S. Food & Drug Administration (FDA) issued regulations implementing the PDMA in 1990 (21 C.F.R. Part 205) and 1999 (21 C.F.R. Part 203). It establishes legal safeguards for prescription drug distribution to ensure safe and effective pharmaceuticals. It is designed to discourage the sale of counterfeit, adulterated, misbranded, sub-potent, and expired prescription drugs. The agency can seek removal of adulterated and misbranded drugs from the market and cause issue of a restraining order against the manufacturer or distributor of the drug.

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