In response to numerous reports of adverse events--including death--associated with the misuse and inappropriate use of UCB's Tussionex Pennkinetic (Extended-Release Suspension), the US Food and Drug Administration has issued an alert on the safe and correct use of this potent cough medication.

Tussionex is a prescription cough medicine containing hydrocodone, a narcotic ingredient, 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 (extended-release).

"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 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.

Tussionex should not be used (is contraindicated) in patients less than 6 years old, the federal regulators said. FDA has received reports of death in children less than 6 years of age who have been prescribed Tussionex.

One of the two ingredients in this long-acting cough product is hydrocodone, a narcotic. Too much hydrocodone can cause life-threatening breathing problems and death.

The manufacturer of Tussionex Pennkinetic Extended-Release Suspension UCB Inc has expressed its willingness to update the labelling, including information that Tussionex should not be prescribed to or used in children less than 6 years of age, as well as the need for accurate dosing.