The FDA said Tussionex Pennkinetic Extended-Release Suspension, which contains hydrocodone and the antihistamine chlorpheniramine, leads to serious adverse events including deaths. The medicine was improperly prescribed for children younger than six and/or at a dosing frequency of less than every 12 hours.
Hydrocodone is a narcotic ingredient present in Tussionex and its overdosing can cause life-threatening side effects and deaths in patients, including children. It resulted from taking more than the recommended dose or taking the medication more frequently than every 12 hours.
There have been reports when Tussionex is sometimes prescribed or given to children younger than 6 years, for whom the medication isn't approved. Patients who are unable to control cough with a dose every 12 hours should consult their physicians before increasing the dose frequency, the FDA said.
Symptoms of hydrocodone overdose include trouble breathing; slow or shallow breathing; slow heartbeat; severe sleepiness; cold, clammy skin; trouble walking or talking; or feeling faint, dizzy, or confused.
Tussionex Pennkinetic Extended-Release Suspension is manufactured by UCB Inc. of Smyrna, Ga. The UCB is now working with FDA to update the label, including information that the cough medicine should not be prescribed for children younger than six.
Previous instructions by FDA include that liquid cough and cold medicines are unsafe and ineffective when used in children younger than two.
