FDA issues warning on UCB's cough medicine

The US Food and Drug Administration has issued an alert on the safe and correct use of Belgian drugmaker UCB's prescription cough medicine Tussionex pennkinetic extended-release suspension in response to numerous reports of serious adverse events, including death. The medicine, which contains the narcotic hydrocodone and the antihistamine chlorpheniramine, is approved for use in adults and children over the age of six years, and should be given no more frequently than every 12 hours extended-release.

"There is a real and serious risk for overdosing if this medication is not used according to the labeling," said Curtis Rosebraugh, Acting Director of the FDA's Office of Drug Evaluation II. Adverse event associated with Tussionex have included life-threatening side effects as a results of patients taking more than the recommended dose or taking the medication more frequently than every 12 hours. The reports also show that Tussionex is sometimes prescribed or given to children less than six years old.