Important Information for the Safe Use of Tussionex Pennkinetic Extended-Release Suspension - Full Version
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On March 11, 2008 the Food and Drug Administration issued a public health advisory titled: Important Information for the Safe Use of Tussionex Pennkinetic Extended Release Suspension.
I am Mandy Eisemann from F-D-A's Center for Drug Evaluation and Research.
FDA is issuing this public health advisory to alert patients, caregivers, and healthcare professionals to important information on the safe and appropriate use of Tussionex Pennkinetic Extended-Release Suspension. Tussionex is a prescription cough medicine containing hydrocodone and the antihistamine, chlorpheniramine that is made to be given every 12 hours because of the extended-release properties of the medicine.
Hydrocodone, the narcotic ingredient in this medicine that controls cough, can cause life-threatening breathing problems and death when given above or more frequently than the recommended dose. Tussionex should not be used in children less than 6 years old.
FDA is highlighting the following important information on the safe use of Tussionex:
- Do not give to children less than 6 years old. FDA has received reports of death due to respiratory depression with use of Tussionex in patients less than 6 years old.
- Healthcare professionals should not prescribe and patients should not take Tussionex more often than every 12 hours. Taking this cough medicine more often than every 12 hours may result in a narcotic overdose. Too much hydrocodone can cause life-threatening breathing problems and death. If the cough is not controlled when taking Tussionex every 12 hours, talk to your doctor before taking more.
- Healthcare professionals who prescribe and patients who use Tussionex should be aware of the signs of hydrocodone overdose including the following: trouble breathing; slow or shallow breathing; slow heartbeat; severe sleepiness; cold, clammy skin; trouble walking or talking; or feeling faint, dizzy, or confused. If these signs occur, patients, parents, or caregivers should get medical attention right away.
- Patients and parents should use a device designed to accurately measure Tussionex. Household teaspoons or tablespoons vary in size and can result in giving too much of the medicine. Use a syringe or spoon specifically designed to measure liquid medicine.
FDA has received reports of death and life-threatening side effects in patients, including children, who have received Tussionex. The reports indicate that doctors have inappropriately prescribed this medicine for patients less than 6 years old and at doses more frequent than every 12 hours. In addition, 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.
FDA has worked with the manufacturer of Tussionex Pennkinetic Extended-Release Suspension, UCB, to update the label, including information that Tussionex is not to be prescribed or used in children less than 6 years old and the need for accurate measurement and dosing.
There are cough products containing hydrocodone that can be given every 4 to 6 hours. FDA is reviewing safety information for these products and will provide updates as new information is available. We urge healthcare providers and patients to report serious side effects that may be associated with the use of Tussionex Pennkinetic Extended Release Suspension to us at the FDA's MedWatch adverse event reporting program by phone at 1-800-F-D-A-ten-88 or by the Internet at F-D-A dot GOV slash M-E-D-W-A-T-C-H.
Updated information about drugs with emerging safety concerns is available 24 hours a day at our Web site W-W-W dot F-D-A dot GOV slash C-D-E-R.
Date created: March 13, 2008
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