FDA issues Tussionex alert

The FDA has issued a health advisory regarding the safe and appropriate use of Tussionex (hydrocodone bitartrate/chlorpheniramine maleate extended-release suspension, from UCB) after receiving reports of life-threatening adverse events, including death. Adverse events occurred when healthcare professionals inappropriately prescribed Tussionex for patients <6 years of age or prescribed a dosing interval more frequent than every 12 hours.

Additionally, parents and caregivers have given this medicine too frequently and have not carefully measured the suspension, resulting in overdoses. Overdose of Tussionex in older children, adolescents, and adults has also been associated with life-threatening breathing problems and death.

For more information visit www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107208.htm.