On March 11, 2008, the Food and Drug Administration (FDA) issued a public health advisory concerning the safety of UCB’s Tussionex Pennkinetic Extended-Release Suspension, a prescription cough medicine containing hydrocodone and the antihistamine chlorpheniramine.

The FDA noted two specific issues. First, the cough medicine was being improperly prescribed for children under age six. Children this young have a particular susceptibility to respiratory depression, a life-threatening condition brought on by hydrocodone overdose, and therefore use of a product such as Tussionex is contraindicated. The FDA has received reports of death in patients less than six years old due to respiratory depression.

Secondly, the FDA found that Tussionex has been prescribed more frequently than the labeled dosing interval of every 12 hours. In addition, misinterpretation of dosing directions and patient use of inappropriate measuring devices has led to excessive dosing of the product. Life-threatening breathing problems and death have been associated with hydrocodone overdose in older children, adolescents, and adults.

Patients are advised not to increase their dosing frequency, and they should use a properly marked measuring device. If they are unable to control cough with a dose every 12 hours, they should consult a physician.

Some symptoms of hydrocodone overdose include:

• trouble breathing
• slow or shallow breathing
• slow heartbeat
• severe sleepiness
• cold, clammy skin
• trouble walking or talking
• feeling faint, dizzy, or confused.

The manufacturer of Tussionex Pennkinetic Extended-Release Suspension, UCB Inc., plans to update the product label to include this information.

Source: Peggy Peck, “FDA Issues Warning on Prescription Cough Medicine Linked to Deaths,” MedPage Today, March 11, 2008.