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QUICK REFERENCE #48: What is the focus of a newly developed Patient Medication Guide pertaining to medications used to treat attention-deficit/hyperactivity disorder (ADHD)?

• The FDA has announced that manufacturers of medications for the treatment of ADHD will develop and provide Patient Medication Guides for distribution to patients, families, and caregivers. This new regulatory step follows the May 2006 labeling revision that described concerns regarding adverse cardiovascular and psychiatric events. Excerpts of the text of the FDA’s Feb 21, 2007 news release follow:


The US Food and Drug Administration (FDA) today directed the manufacturers of all drug products approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) to develop Patient Medication Guides to alert patients to possible cardiovascular risks and risks of adverse psychiatric symptoms associated with the medicines, and to advise them of precautions that can be taken.

. . . An FDA review of reports of serious cardiovascular adverse events in patients taking usual doses of ADHD products revealed reports of sudden death in patients with underlying serious heart problems or defects, and reports of stroke and heart attack in adults with certain risk factors. Another FDA review of ADHD medicines revealed a slight increased risk (about 1 per 1,000) for drug-related psychiatric adverse events, such as hearing voices, becoming suspicious for no reason, or becoming manic, even in patients who did not have previous psychiatric problems.

FDA recommends that children, adolescents, or adults who are being considered for treatment with ADHD drug products work with their physician or other health care professional to develop a treatment plan that includes a careful health history and evaluation of current status, particularly for cardiovascular and psychiatric problems (including assessment for a family history of such problems).

SOURCE: The Complete Practitioner: Mental Health Applications (March 2007), with text excerpted from an FDA news release.

The full text of the news release is available online at http://www.fda.gov/bbs/topics/NEWS/2007/NEW01568.html.

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