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The U.S. Food and Drug Administration issued an alert today 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 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.
Highlights of the FDA’s recommendations to health care professionals include:
Highlights of the FDA’s recommendations to patients include:
The manufacturer of Tussionex Pennkinetic Extended-Release Suspension (UCB Inc, Smyrna, Ga.) has agreed to update the labeling, 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.
For more information and the full list of the FDA's recommendations, visit http://www.fda.gov/cder/drug/infopage/hydrocodone/default.htm
This alert does not impact short-acting cough products containing hydrocodone that can be given every 4 to 6 hours. However, the FDA is reviewing safety information on these other hydrocodone containing cough products and will provide updates as new information becomes available.
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