EBD Blog

Wednesday 21 February 2007 the US Federal Drug Administration ordered that medications for treating ADHD must carry warnings about possible risks associated with taking them. The drugs place people taking them at risk for cadiovascular problems and adverse psychiatric reactions. Here are the first paragraphs of the press release:

The U.S. 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.

“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, 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.”

Patient Medication Guides are handouts given to patients, families and caregivers when a medicine is dispensed. The guides contain FDA-approved patient information that could help prevent serious adverse events. Patients being treated with ADHD products should read the information before taking the medication and talk to their doctors if they have any questions or concerns.

The drugs that are affected by this order include these: Adderall Tablets, Adderall XR Extended-Release Capsules; Concerta Extended-Release Tablets; Daytrana Transdermal System; Desoxyn Tablets; Dexedrine Spansule Capsules and Tablets; Focalin Tablets, Focalin XR Extended-Release Capsules; Metadate CD Extended-Release Capsules; Methylin Oral Solution, Methylin Chewable Tablets; Ritalin Tablets, Ritalin SR Sustained-Release Tablets, Ritalin LA Extended-Release Capsules; Strattera Capsules.

Link to the full FDA press release.