FDA Sends Tussionex Warning Following Reports of Overdose, DeathsMar 12, 2008 | Parker Waichman LLP
A Tussionex alert has been issued by the Food & Drug Administration (FDA), following reports of deaths and other adverse events associated with misuse of the prescription cough medicine. The FDA Tussionex alert comes after the drug’s maker, UCB SA of Belgian, contacted the FDA about updating safety information on the Tussionex label regarding proper dosage.
Tussionex, sold as Tussionex Pennkinetic Extended-Release Suspension, is one of eight prescription cough medicines that contain the narcotic pain reliever hydrocodone. Hydrocodone is habit-forming, and can lead to physical and psychological addiction. A hydrocodone overdose is possible when too much of the drug is used. An overdose of hydrocodone can be fatal.
Five deaths have been reported among children under 6 who took the Tussionex since its approval in 1987. Tussionex has only been approved for adults and children over 6. The Tussionex label says specifically that the drug is not intended for use in children under 6, but the reports of pediatric deaths suggest that those warnings are inadequate.
In its health alert, the FDA said 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.
The FDA is warning healthcare providers that Tussionex should not be used in patients less than 6 years old. Practitioners have also been advised to consult the prescribing information to determine the correct dose and dosing frequency of Tussionex, and to be aware that Tussionex is an extended-release formulation that should not be prescribed at an interval less than 12 hours. Finally, the FDA has cautioned healthcare providers to discuss with patients the amount of and frequency of Tussionex to be given, and to instruct patients not to take Tussionex more frequently than every 12 hours.
The FDA is advising patients that one of the two ingredients in Tussionex is hydrocodone, a narcotic. Too much hydrocodone can cause life-threatening breathing problems and death. People taking Tussionex have been advised to call a doctor right away if they experience trouble breathing, slow heartbeat, severe sleepiness or cold, clammy skin. They have also been reminded to use appropriate measuring instruments in order to measure the correct dose of Tussionex, and to be certain that doses of Tussionex are taken in at least 12 hour intervals.
The FDA also said that UCB SA has agreed to update the drug’s labeling to include 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.