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FDA warns on cough drug

The US FDA has updated the labelling of Tessalon liquid cough capsules stating the product poses a risk for young children as it resembles candy

The US Food and Drug Administration (FDA) has updated the labeling of Tessalon (benzonatate) liquid cough capsules and issued a public advisory stating that the product poses a poisoning risk for young children because it looks like candy.

The round-liquid filled capsules are approved in the US to treat cough symptoms in patients older than 10 and can cause serious side effects or even death when they are accidentally ingested by younger children, the FDA said. 

The new warning states that the product should be kept in a childproof container and stored away from children.  The FDA is also encouraging healthcare providers to discuss the accidental ingestion risk associated with the product with their patients.

The alert is based on data from the FDA's Adverse Event Reporting System which showed that from 1982 through May 2010 there were seven cases of accidental ingestion associated with benzonatate in children younger than 10. Five of the cases resulted in death in children ages 2 years or younger.

Adverse events commonly associated with overdose of the medicine include cardiac arrest, coma, and convulsion. In the cases reported to the FDA database, symptoms sometimes came on within minutes, and death resulted within hours. Overdose can be caused in young children by ingestion of even just one or two capsules of the drug, the agency noted.

15th December 2010


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