The FDA said a 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.
In May 2006, the FDA told manufacturers of ADHD products to revise product labeling for doctors to reflect concerns about adverse cardiovascular and psychiatric events. To help patients understand these risks, an additional part of this revised labeling process is the creation of a patient medication guide for each individual product.
“Medicines approved for the treatment of ADHD have real benefits for many patients but they may have serious risks as well,” said Steven Galson, managing director, director, Center for Drug Evaluation and Research (CDER).
“In our ongoing commitment to strengthen drug safety, FDA is working closely with manufacturers of all ADHD medicines to include important information in the product labeling and in developing new patient medication guides to better inform doctors and patients about these concerns,” Mr Galson added.