ADHD Drug Dexedrine to Receive Stronger Warning Label

By Elizabeth Rhein

Published on August 23, 2006

Dexedrine is a stimulant used to treat attention deficit hyperactivity disorder, or ADHD, in children, teens, and adults. The FDA has asked GlaxoSmithKline and the makers of other ADHD drugs to alert patients and doctors to the possible increased risk of heart problems associated with the medications. This particular side effect may be responsible for fatalities among children and teens with heart conditions not related to the ADHD drugs.

In addition to agreeing to change the warnings on Dexedrine’s packaging, GlaxoSmithKline sent a letter to healthcare providers detailing the issue. The letter is available on the FDA website.

The planned changes to the drug’s labeling follow a months-long discussion about the need for stronger labeling on stimulants used for ADHD treatment. In February 2006, an advisory committee recommended to the FDA that ADHD drugs be given the so-called “black box" warning, the most severe caution, following reports of deaths among children who were given the drugs. One month later, a different FDA pediatric advisory committee advised against the warning, recommending instead that doctors be given in-depth information about the drugs' risks. This is the option the FDA adopted.

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