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Information for Healthcare Professionals: Long-Acting Hydrocodone-Containing Cough Product (marketed as Tussionex Pennkinetic Extended-Release Suspension)

FDA ALERT 3/11/08:  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.


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 page.

Healthcare professionals who prescribe Tussionex Pennkinetic Extended-Release Suspensioncontaining hydrocodone, a narcotic cough suppressant, and the antihistamine, chlorpheniramine should be fully aware of all the prescribing information.  Following are highlights of the updated important safety information from the prescribing information.

Recommendations and Considerations for Healthcare Professionals

  • Tussionex 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.  The safety and effectiveness of Tussionex have not been evaluated in children less than 6 years of age. 

     
  • 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.  Because it contains a narcotic, prescribing too high of a dose or too frequent a dose in a patient of any age can result in serious respiratory depression and possibly death.     
     
  • Prescribers should clearly state the prescribed volume in milliliters.  Pharmacists should clearly state the directions in milliliters on the prescription container, double-check volume conversions, provide a measuring device that can deliver the volume in milliliters as prescribed, and counsel patients how to correctly measure the suspension.  Some of the reports received by FDA indicate that medication errors occurred due to the incorrect conversion from the volume prescribed by a physician to the volume indicated on the prescription label (e.g., 2 milliliters from a physician’s order was converted to 2 teaspoons on the prescription label).

     
  • Discuss with the patient the amount of Tussionex to be given and the frequency of dosing.  Instruct patients not to take and parents not to administer it more frequently than every 12 hours.  If the cough is not controlled, patients or parents should talk to their doctor.

Information for the patient: Prescribers and pharmacists should discuss the following information about Tussionex with patients and their caregivers:

  • One of the two ingredients in Tussionex is hydrocodone, a narcotic.  Too much hydrocodone can cause life-threatening breathing problems and death.  Call your doctor right away if you have
    • trouble breathing or slow or shallow breathing
    • slow heartbeat
    • severe sleepiness
    • cold, clammy skin

       
  • Read and understand the directions that you receive with your Tussionex prescription.  This medicine is made to be taken every 12 hours (“extended-release”).  Do not take more often because you may overdose on hydrocodone.  Talk to your doctor if your cough is not controlled when taking the medicine every 12 hours.

     
  • Do not mix Tussionex with any other fluids.  Tussionex is designed to be slowly released over 12 hours.  Mixing with other fluids prior to giving the medicine may result in increasing this release rate and can result in an overdose.

     
  • For Tussionex, use a medicine syringe or other device designed to measure liquid medications.  A household teaspoon or tablespoon should not be used because they vary in size and you may receive too much or too little of the medicine.  Ask your doctor or pharmacist if you are unsure how to measure the medicine. 

Background Information and Data

FDA has reviewed over 100 adverse event reports, including reports of medication errors, associated with the use of Tussionex.  Thirty-three of the cases involved children less than 18 years of age, twenty-four of which were in children less than 6 years of age.  In the reports involving children less than 6 years old, there were 9 reports of death, 7 additional reports of respiratory depression, and 2 reports of somnolence.  Most cases over 6 years of age were associated with accidental or intentional overdose. 

The reports indicate:

  • Doctors prescribed Tussionex more frequently and at higher doses than recommended in the prescribing information.
  • There is confusion when converting from the dosing units written on the prescription to the dosing units provided on the prescription instructions (e.g. milliliters to teaspoon).
  • Parents administered Tussionex at higher doses than prescribed due to confusion in dosing (converting milliliters to teaspoonful or using a household tablespoon)
  • Parents administered Tussionex to their children under 6 years of age when it had not been prescribed for the child.

FDA has worked with the manufacturer of Tussionex Pennkinetic Extended-Release Suspension, UCB, Inc., to update the prescribing information with a contraindication for use in children less than 6 years of age and with other information for safe use of the product, including the need for use of an accurate dosing device.

There are cough products containing hydrocodone that can be given every 4 to 6 hours (short-acting hydrocodone cough products).  FDA is reviewing safety information for these products and will provide updates as new information is available.

 

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