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Issue Warnings on ADHD Drugs, FDA Tells Their Manufacturers

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The U.S. Food and Drug Administration last week directed the manufacturers of all drugs approved for the treatment of attention deficit hyperactivity disorder to develop new patient medication guides to alert people to possible cardiovascular risks and risks of adverse psychiatric symptoms associated with taking the medicines.

The guides, which are given to patients, families, and caregivers when a medicine is dispensed, contain information that could help prevent serious problems, the federal agency said in a press release.

A review by the FDA revealed reports of sudden death in patients with underlying serious heart problems or defects, and reports of stroke or heart attack in adults with certain risk factors. Another review found a slightly increased risk for drug-related psychiatric events, such as hearing voices, becoming suspicious for no reason, or becoming manic.

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See Also
For more stories on this topic see Safety and Health. For background, previous stories, and Web links, read Student Health.

Vol. 26, Issue 25, Page 8

Published in Print: February 28, 2007, as Issue Warnings on ADHD Drugs, FDA Tells Their Manufacturers

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