Safety Alerts & Recalls

What does this mean?

Today's alert reinforces the dangers associated with using medications more frequently or in higher doses than those recommended in the approved prescribing information.

If you are using this medication, make sure that you:

* Use a medicine syringe or other device designed to measure liquid medications (DO NOT use a household teaspoon) when measuring your doses. Ask your doctor or pharmacist if you are unsure how to measure the medicine;

* Talk to your doctor If the cough is not controlled despite taking the prescribed dose at the recommended interval;

* Call your doctor right away if you have taken this medicine and have trouble breathing, slow heartbeat, severe sleepiness or cold, clammy skin.

Public health advisory on the proper use of Tussionex

The FDA issued an public health advisory today regarding the safe and correct us of Tussionex Pennkinetic Extended-Release Suspension. The alert follows numerous reports of serious problems - including death - associated with the misuse of this medication.

Tussionex is a prescription cough medicine containing hydrocodone, a narcotic ingredient, and the antihistamine chlorpheniramine. The product is approved for use in adults and children over the age of six years old, and should be given no more frequently than every 12 hours ("extended-release"). Too much hydrocodone, particularly when used in combination with chlorpheniramine, can cause life-threatening breathing problems and death.

The alert emphasizes that patients SHOULD NOT take this medication more frequently than every 12 hours, and SHOULD NOT take more than the recommended dose. It also emphasizes that this medication SHOULD NOT be used in children less than 6 years old, for whom this medication is not approved.

For more information, please visit: more information here

Source: FDA
Publication Date: 2008-03-11
Last Updated: 2009-12-06

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