US Pharm. 2008;33(4)64.

The FDA issued an alert on the safe and correct use of Tussionex Pennkinetic Extended-Release Suspension in response to numerous adverse event reports, including death, associated with the misuse and inappropriate use of the strong cough medication. Tussionex, a prescription drug that contains the narcotic hydrocodone, can cause life-threatening breathing problems and death when recommended doses are exceeded. Tussionex is approved for use in adults and children older than 6 and should be given no more frequently than every 12 hours.

Adverse event reports indicate that 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 younger than 6, an age group for whom this medication is not approved. UCB Inc., the drug's maker, agreed to update the labeling, including information that Tussionex should not be prescribed to or used in children younger than 6, as well as the need for accurate dosing.


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