FDA issues warning about combination cough medicine.

Deaths and life-threatening side effects associated with the misuse of a long-acting prescription cough medicine that contains hydrocodone have prompted the Food and Drug Administration to issue a public health advisory about the dangers of the product when not used properly.

The product, marketed as Tussionex Pennkinetic Extended-Release Suspension, combines the narcotic hydrocodone and the antihistamine chlorpheniramine, which is approved for adults and for children over age 6. It should not be given more frequently than every 12 hours and is contraindicated in children under age 6, according to the FDA advisory.

The FDA has received "numerous" reports of deaths and other adverse events in adults and children "associated with the misuse and inappropriate use of this potent cough medicine," the statement said.

The reports indicate that physicians and other health professionals have prescribed Tussionex for children under age 6, or more frequently than the labeled dosing interval of every 12 hours. The reports also indicate that patients have taken the incorrect dose because they have misinterpreted the dosing directions or have used inappropriate devices to measure the suspension.

"There is a real and serious risk for overdosing if this medication is not used according to the labeling," Dr. Curtis Rosebraugh, acting director of the FDKs Office of Drug Evaluation II, said in the statement. Overdoses in children older than 6 years, adolescents, and adults have also resulted in life-threatening and fatal cases of respiratory depression.

Tussionex is manufactured by UCB Inc., which has agreed to update the labeling to include information that it should not be used in children under age 6, and that it should be dosed accurately.

In addition to the warning not to use the product in children younger than age 6 years, the advisory recommends that health care professionals consult the prescribing information to determine the correct dose and dosing frequency of Tussionex. The FDA's other recommendations for using the product safely include the following:

* Health care professionals should not prescribe Tussionex to be taken more frequently than every 12 hours.

* Health care professionals and patients who use the product should be aware of the signs of hydrocodone overdose.

* Prescribers should clearly state the prescribed volume in milliliters. Pharmacists should clearly state directions in milliliters on the prescription container, and provide a measuring device that derivers the volume in milliliters. (The FDA has received some reports indicating that the volume prescribed by the physician was incorrectly converted to another volume on the prescription label, such as 2 mL to 2 teaspoons).

* Patients should be counseled about the amount of Tussionex that should be given and at what frequency.

More information is available at www.fda.gov/cder/drug/infopage/ hydrocodone.

BY ELIZABETH MECHCATIE

Senior Writer