FDA: Tessalon should be packaged in childproof containers

12/15/2010

SILVER SPRING, Md. — A prescription cough suppressant should be kept in childproof containers because of its candy-like appearance, the Food and Drug Administration warned Tuesday.


Tessalon (benzonatate) is made by Forest Labs and comes in the form of a round, liquid-filled gelatin capsule. The drug is used to relieve cough in patients older than 10 years of age.


The FDA’s warning followed a review of its Adverse Event Reporting System, a database of bad reactions to drugs, showing that five children ages 2 years and younger died after accidentally ingesting the drug between 1982 and mid-2010, and overdoses in children younger than 2 years old have been reported following ingestion of one or two capsules.

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