Long-Acting Hydrocone-Containing Cough Product (Tuxxionex Pennkinetic Extended-Release Suspesnsion) (March 11, 2008)

FDA has issued the warning of life-threatening adverse events and death in patients who have received Tussionex due to imprecise dosing. Life-threatening and fatal resipratory depression has occured in children, adolescents, and adults. The drug is contraindicted in children under 6 years of age due to their increased susceptibility to these adverse events.