On February 21, 2007, the U.S. Food and Drug Administration (FDA) sent letters to manufacturers of all medications used to treat attention deficit hyperactivity disorder (ADHD), ordering them to warn patients of possible cardiovascular and psychiatric risks. Manufacturers must include new FDA-approved language in Patient Medication Guides to reflect these warnings within the next 30 days.
Strokes and heart attacks have been reported in adults with particular risk factors. Serious cardiovascular adverse events – including sudden death – have been reported in patients with underlying heart problems or defects.
Psychiatric risks include the development of hallucinations, delusions, and mania, even in patients without a history of these or other psychiatric problems. The risk for these events is approximately 1 per 1000.
There has been dissent within the FDA over the issue of getting information about these risks to the public. In 2006, the FDA’s Drug Safety and Risk Management Committee called for placing “black box” warnings on drugs used to treat ADHD, due to concern over possible heart risks. However, an FDA pediatric advisory panel decided instead that adding information on cardiovascular and psychiatric risks to labels would suffice. The FDA ultimately went with the latter decision.
The drugs which are required to carry the new warnings include: Adderall, Adderall XR, Concerta, Daytrana, Desoxyn, Dexedrine, Focalin, Focalin XR, Metadate CD, Methylin Oral Solution, Methylin Chewable Tablets, Ritalin, Ritalin SR, Ritalin LA, and Strattera. Strattera must carry a black-box warning, stating that it may cause children to have suicidal thoughts.
“Medicines approved for the treatment of ADHD have real benefits for many patients but they may have serious risks as well,” said Steven Galson, M.D., Director of the 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.”
The FDA intends to inform physicians as well as patients and families about the need for taking a thorough medical history, performing a physical examination, and watching patients closely for adverse symptoms.
Attention deficit hyperactivity disorder affects between 3 and 7 percent of school-aged children and approximately 4 percent of adults. The primary characteristics of ADHD are: difficulty paying attention, hyperactivity, and poor impulse control. It is believed that about 2.5 million children and 1.5 million adults are currently being treated with ADHD drugs. The number of adults aged 20 to 44 who take ADHD medications has risen dramatically – a 139 percent increase from 2000 to 2005.
Food and Drug Administration
Press release: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01568.html