FDA Issues Alert on Tussionex

Chrissie Cole

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The FDA has issued a safety alert regarding the proper use of Tussionex Extended-Release Suspension, a potent long acting prescription cough medication, following several reports of adverse events - including death - associated with inappropriate use.

The medication contains hydrocodone (a narcotic) and chlorpheniramine (an antihistamine) and is prescribed for use in adults and children six years of age and older.

"There is a real and serious risk for overdosing if this medication is not used according to the labeling," said Curtis Rosebraugh, M.D., M.P.H., acting director of the FDA's Office of Drug Evaluation II. "Today's action is an example of the FDA working with drug manufacturers throughout a product's lifecycle to keep health care professionals and patients informed of new safety data."

Adverse events reports associated with Tussionex include life threatening side effects and death in patients, including young children.

The reports also revealed that doctors are at times prescribing the drug, and patients are at times staking more than the recommended dosage or taking the medication more frequently then recommended.

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