The U.S Food and Drug Administration issued an alert on the safe use of Tussionex Pennkinetic Extended Release Suspension. The alert is in reposnse to numerous reports of adverse events including death due to improper use of the product.
The prescription cough medicine contains hydrocodone, which is a narcotic, and the antihistamine chlorpheniramine...
...and is approved for adults and children over 6 years of age. The dosage should not be exceeded nor taken more often than every 12 hours.
“There is a real and serious risk for overdosing if this medication is not used according to the labeling,” said Curtis Rosebraugh, M.D., M.P.H., acting director of the FDA's Office of Drug Evaluation II. “Today’s action is an example of the FDA working with drug manufacturers throughout a product’s lifecycle to keep health care professionals and patients informed of new safety data.”
Tussionex should not be used by anyone under 6 years of age, should not be taken more often than every 12 hours and patients should not exceed the recommended dosage.
Should anyone taking the medication experience trouble breathing, slowed heart beat, severe sleepiness and/or cold clammy skin they should contact a health care professional immediately.
The manufacturer, UBC Inc., has agreed to update labeling to include the age and dosage warnings.
[Source: FDA]
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