FDA Alert Issued on Safe Use of Tussionex

March 12, 2008

The U.S. Food and Drug Administration issued an alert on March 11 on Tussionex Pennkinetic Extended-Release Suspension, a prescription-only cough syrup manufactured by UCB Inc., of Smyrna, Ga., to warn of adverse events associated with misuse of the drug.

WEDNESDAY, March 12 (HealthDay News) -- The U.S. Food and Drug Administration issued an alert on March 11 on Tussionex Pennkinetic Extended-Release Suspension, a prescription-only cough syrup manufactured by UCB Inc., of Smyrna, Ga., to warn of adverse events associated with misuse of the drug.

Adverse event reports show that the medication has been prescribed and taken above the recommended dose or more frequently than every 12 hours. There are also adverse event reports of children under the age of 6 years, in whom the drug is contraindicated, being given the medicine.

There have been cases of life-threatening side effects and deaths, the FDA alert states. One of the two active ingredients, the narcotic hydrocodone, can cause life-threatening breathing problems and death, and the medicine should be administered using a medical syringe or other accurate measure to avoid underdosing or overdosing.

"There is a real and serious risk of overdosing if this medication is not used according to the labeling," said Curtis Rosebraugh, M.D., acting director of FDA's Office of Drug Evaluation II, in a statement. This "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."

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