Misuse of Tussionex leads to ADR reports, FDA warning

March 13, 2008

FDA issues warning on Tussionex use

The Food & Drug Administration has issued a warning to practitioners on the appropriate use of Tussionex Pennkinetic Extended-Release Suspension, containing hydrocodone. Reports received by the agency have revealed that physicians and other healthcare professionals are inappropriately prescribing the medication, leading to serious adverse events in some cases, including death. The FDA warning reminds practitioners that the cough suppressant is not to be administered any more frequently than every 12 hours and is contraindicated in children less than six years old. In addition, prescribers should consult the prescribing information to determine an accurate dose, and should instruct patients not to take the cough medicine any more frequently than every 12 hours, using a medicine syringe for measuring the dose rather than a household teaspoon or tablespoon. According to the FDA, the alert does not impact the short-acting cough products containing hydrocodone that can be given every four to six hours; however, the agency is currently reviewing safety information on these other products and will provide updates as new information becomes available. Tussionex Pennkinetic is manufactured by UCB Inc.

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