FDA releases guidance on safe use of Tussionex

ROCKVILLE, Md. The Food and Drug Administration issued an alert Tuesday on the safe and correct use of Tussionex Pennkinetic Extended-Release Suspension in response to numerous reports of adverse events—including death—associated with the misuse and inappropriate use of the prescription cough medication.

“There is a real and serious risk for overdosing if this medication is not used according to the labeling,” stated Curtis Rosebraugh, 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.”

Tussionex contains hydrocodone and the antihistamine chlorpheniramine. The product is approved for use in adults and children over the age of six years old, and should be given no more frequently than every 12 hours.

Adverse event reports associated with Tussionex have included life-threatening side effects and deaths in patients, including children. These reports reveal physicians and other health professionals are sometimes prescribing, and patients are sometimes taking, more than the recommended dose or taking the medication more frequently than every 12 hours. The reports also show that Tussionex is sometimes prescribed or given to children less than 6 years old, for whom this medication is not approved.

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