Information on Long-Acting Hydrocodone-Containing Cough Product (marketed as Tussionex Pennkinetic Extended-Release Suspension)

FDA ALERT [3/11/2008] - FDA is highlighting important information about how to safely use Tussionex Pennkinetic Extended-Release Suspension, a long-acting hydrocodone-containing cough product.    

FDA has received reports of life-threatening adverse events and death in patients, including children, who have received Tussionex Pennkinetic Extended-Release Suspension (Tussionex).  The reports indicate that healthcare professionals have prescribed Tussionex for patients younger than the approved aged group of 6 years old and older, more frequently than the labeled dosing interval of every 12 hours, and that patients have administered the incorrect dose due to misinterpretation of the dosing directions and use of inappropriate devices to measure the suspension.  Overdose of Tussionex in older children, adolescents, and adults has also been associated with life-threatening and fatal respiratory depression. 

Tussionex is contraindicated for use in patients less than 6 years of age because of their susceptibility to life-threatening and fatal respiratory depression.  Prescribers should be familiar with the dosing recommendations of Tussionex before prescribing.  In addition, patients and caregivers should use a properly marked measuring device to measure Tussionex to prevent overdose.  FDA has worked with the manufacturer of Tussionex to update the prescribing information.

This information reflects FDA's current analysis of data available concerning this drug. FDA intends to update this when additional information or analyses become available.

 

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Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this sheet.