Special Alerts:

[Posted 02/21/2007] FDA notified healthcare professionals that the manufacturers of all drug products approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) have been directed 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. Patient Medication Guides (http://www.fda.gov/cder/Offices/ODS/medication_guides.htm) are handouts given to patients, families and caregivers each time a medicine is dispensed. The guides contain FDA-approved patient information that could help prevent serious adverse events.

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. 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). For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#ADHD, http://www.fda.gov/cder/drug/infopage/ADHD/default.htm and http://www.fda.gov/bbs/topics/NEWS/2007/NEW01568.html.

[Posted 08/21/2006] The FDA and GlaxoSmithKline notified healthcare professionals of changes to the BOXED WARNING, WARNINGS and PRECAUTIONS sections of the prescribing information for dextroamphetamine sulfate (Dexedrine), approved for the treatment of Attention-Deficit Hyperactivity Disorder and narcolepsy. The warnings describe reports of sudden death in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2006/safety06.htm#Dexedrine, http://www.fda.gov/medwatch/safety/2006/Dexedrine_DHCP_Letter.pdf and http://www.fda.gov/medwatch/safety/2006/Dexedrine_PI.pdf.