Safety Alert for Tussionex Prescription Cough Medicine

March 2008

In the midst of a hard-hitting flu season, a safety alert has been issued on the very medicine that some doctors may prescribe to alleviate their patients’ symptoms. The U.S. Food and Drug Administration (FDA) is warning doctors and consumers about the life-threatening hazards of misusing the prescription cough medication, Tussionex.

The FDA has received numerous reports of adverse reactions to Tussionex Pennkinetic Extended-Release Suspension, including death. The medication contains hydrocodone, a narcotic that can cause life-threatening breathing problems or death when too much is ingested. Tussionex is approved for use in adults and children over the age of six and should not be taken more than once every 12 hours.

The FDA has found that health professionals sometimes prescribe, and patients sometimes take, more than one dose of Tussionex every 12 hours. Another common misuse is giving the medication to children under the age of six. The manufacturer of Tussionex has agreed to update the drug’s label, making dosage and prescribing instructions more clear.