FDA Issues Alert on Tussionex

by fpw | March 13th, 2008

The Food and Drug Administration has released a warning on the cough medication Tussionex, which contains hydrocodone. Cases of serious adverse events, including death, have been reported in people and children using the product.

Tussionex is a prescription cough medicine that is used by both adults and children. It contains the potent narcotic hydrocodone and has the potential for overdose if used improperly. The warning issued by the FDA includes the following language:

  • Tussionex should not be used (is contraindicated) in patients less than 6 years old. FDA has received reports of death in children less than 6 years of age who have been prescribed Tussionex.
  • Consult the prescribing information to determine the correct dose and dosing frequency of Tussionex. Tussionex is an extended-release formulation that should not be prescribed at an interval less than 12 hours.
  • Discuss with the patient the amount of and frequency of Tussionex to be given. Instruct patients not to take, and parents not to administer Tussionex more frequently than every 12 hours.

Be sure to follow dosing instructions to avoid a potential Texas drug injury or death.

Click here to read more http://www.fda.gov/bbs/topics/NEWS/2008/NEW01805.html