FDA Calls for Strongest Warning on ADHD Drugs

By Shae, March 2006

The Food and Drug Administration advisory panel voted 8-7 to add a “black box” warning to stimulants used to treat attention-deficit hyperactivity disorder (ADHD) because of cardiac risks. This recommendation came after shocking reports of the deaths of 25 people, 19 of them children, using these medications (USA Today).

The affects of these medications are immense. About two million children and one million adults are prescribed medications for ADHD each month. Of the stimulant drugs used to treat ADHD, the four biggest sellers in 2005 are: Adderall XR, $974 million; Concerta, $837 million; Ritalin LA, $132 million; and Metadate CD, $91 million. FDA’s counterpart in Canada, Health Canada, pulled Adderall off the market a year ago due to these cases of sudden death, heart attack, or stroke (IMS Health).

In 2003, about 4.4 million children aged 4 to 17 (7.8 percent of U.S. children) reported having been diagnosed with ADHD at some point. Furthermore, 4.3 percent of American children in this age range have never even been diagnosed and are still taking medication.

The advisory panel admits that it could take years to conduct the necessary studies to answer all of the questions to confirm whether the ADHD drugs really increase the risk of cardiovascular problems or not. However, it is imperative that patients and parents of patients are aware of the risks involved with these stimulants.

Sources

  • Rubin, R. (2006, March 10). Warning advised on ADHD drugs. USA Today.
  • Gardner, A. (2006, March 11). FDA Panel calls for strongest warning on ADHD drugs. MSN Health and Fitness. Retrieved March 17, 2006, from http://health.msn.com/centers/adhd
  • IMS Health
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