The FDA has directed the makers of all drug products approved for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) to develop patient-medication guides to alert patients to possible associated cardiovascular risks and risks of adverse psychiatric symptoms and to advise them of precautions.
The handouts are given to patients, families, and caregivers when a drug is dispensed. Patients using ADHD products should read the information before taking the medication and should talk to their doctors if they have any concerns.
The new guides reflect changes ordered last May in the warnings section of the physician labeling.
From 1993 to February 2005, the FDA received 27 reports of unexpected death in patients under 18 years of age who had taken one of the medications. It is not clear whether the deaths resulted from the ADHD drugs or from underlying cardiovascular problems.
The following drugs are the focus of the revised labeling and new patient guides: canadian Adderall, Concerta, Daytrana Transdermal System, Desoxyn, Dex-edrine Spansule, Focalin, Metadate CD, Methylin oral solution and chewables, Ritalin, and Strattera.