Healthy Skepticism Library item: 13158

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

FDA cautions on UCB's cough drug usage
Pharmaceutical Business Review 2008 Mar 12
http://www.pharmaceutical-business-review.com/article_news.asp?guid=8559F5BF-C659-497E-A334-CE0EAD572DA2

Full text:

The FDA has issued an alert on the safe and correct use of Tussionex Pennkinetic extended-release suspension in response to numerous reports of adverse events – including death – associated with the misuse and inappropriate use of this potent cough medication.

Adverse event reports associated with Tussionex have included life-threatening side effects and deaths in patients, including children. The reports show that Tussionex is sometimes prescribed or given to children less than 6 years old, for whom this medication is not approved. UCB, the manufacturer of Tussionex Pennkinetic extended-release suspension, has agreed to update the labeling, including information that Tussionex should not be prescribed to or used in children less than 6 years of age, as well as the need for accurate dosing.

Tussionex is a prescription cough medicine containing hydrocodone, a narcotic ingredient, and the antihistamine chlorpheniramine. The product is approved for use in adults and children over the age of six years old, and should be given no more frequently than every 12 hours.

Curtis Rosebraugh, acting director of the FDA’s Office of Drug Evaluation II, said: “There is a real and serious risk for overdosing if this medication is not used according to the labeling.”