Unsafe Use of Extended-Release Tussionex Suspension

Posted on April 29, 2008

FDA is cautioning healthcare professionals, patients and caregivers about the unsafe use of Tussionex Pennkinetic Extended-Release Suspension. This product is a long-acting cough suppressant containing hydrocodone, a narcotic antitussive, and chlorpheniramine, an antihistamine. Overdoses of hydrocodone can result in respiratory depression and death. FDA has reviewed over a hundred adverse event reports associated with this product. Twenty four reports were in children under the age of six, nine of whom died.

Tussionex is not approved for children under six because of the risk of respiratory depression and death. Even though it is specifically contraindicated in this age group some physicians are prescribing this product for them. Also, family members may take a prescription for an older family member and give it to younger children.

Irrespective of the child's age, parents are also running into trouble when they try to measure the dose. For example, they may be using ordinary teaspoons, which can vary in size. Pharmacists can contribute to the problem if they mis-state the dose on the prescription label. In one case, the physician's order of 2 mL was written as two teaspoons on the label.

Another problem with any long-acting or extended-release medication is that patients or caregivers may be tempted to use it more often than it is prescribed. Some of the reports also indicated that physicians were prescribing it to be taken more often than every 12 hours.

To help avoid these overdoses, FDA is working with the manufacturer to strengthen the prescribing information and the instructions for use. But preventing these kinds of tragedies requires understanding and vigilance from everyone involved.

• Prescribers should not prescribe the product for children under six. They should specify that it not be taken more often than every 12 hours and also specify the dose on the prescription in milliliters.

• Pharmacists should clearly state the dose in milliliters on the prescription label, give the patient or parent a measuring device that can deliver this dose in milliliters, and counsel them on how to use it.

• Patients or parents should understand that they should not use more of the drug than prescribed, or use it more often than prescribed or give it to anyone under the age of six. The proper device should be used to measure the dose. In addition, this medicine should not be mixed with any other fluids before taking it or giving it to someone else, because this could increase the release rate of the drug and that could result in an overdose. Patients and parents should also be alert to the symptoms of hydrocodone overdose, including, respiratory depression, extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold, clammy skin and sometimes bradycardia or hypotension.

Additional Information:

FDA MedWatch Safety Alert. Long-Acting Hydrocodone-Containing Cough Product (marketed as Tussionex Pennkinetic Extended-Release Suspension). March 11, 2008.
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tussionex

FDA Press Release. FDA Issues Alert on Tussionex, a Long-Acting Prescription Cough Medicine Containing Hydrocodone. March 11, 2008.
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01805.html