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  Vol. 299 No. 16, April 23/30, 2008 TABLE OF CONTENTS
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Cough Drug Warning

Bridget M. Kuehn

JAMA. 2008;299(16):1891.

Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The Food and Drug Administration (FDA) is warning patients and physicians about serious health risks associated with misuse of Tussionex Pennkinetic Extended-Release Suspension, a prescription cough medicine containing hydrocodone.

The medication, which is FDA-approved for use in children older than 6 years and in adults, should not be given more frequently than every 12 hours. However, the agency has received reports of serious adverse events, including death, in patients younger than 6 years who were given the drug and in adults who have taken more than the recommended dose. In some cases, physicians prescribed the drug to children younger than 6 years; in others, a physician or other clinician advised patients to take more than the recommended dose.

The product's labeling has been updated to reflect these risks. The FDA is reminding physicians that this product is contraindicated for children younger than 6 years and advising them . . . [Full Text of this Article]







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