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FDA Issues Advisory on ADHD Drug Strattera

Rare Reports of Suicidal Thinking Cited; Drug to Get 'Black Box' Warning Label

Be Aware, but Don't Panic

FDA warnings are generally "very positive and very necessary," says Rothe. However, he says those warnings often get blown out of proportion by the media and misunderstood by the public.

"Every time there's one of these warnings, the media presents this as, 'This is real high danger stay away from this.' The problem is that any medication is going to have side effects," says Rothe.

"The way it's presented to the public is that it it's some kind of catastrophic alarm that people should stay away from the medications. What it really means is that you just have to be careful and that people need to be treated carefully and by the right specialists and with enough frequency between visits so that the treatment can be conducted safely," says Rothe.

"The brain is the most complicated organ in the human body," he continues. "We've been to the moon and we still don't understand a lot of how the brain works. ... So this is all very new stuff," says Rothe.

Depression's Effects?

Rothe also notes that about a quarter of children with ADHD also have depression. "Could it be that what they're really seeing is symptoms of depression that's happening at the same time?" he asks.

"In adolescents, it's very common to be overwhelmed by a problem and think, 'Oh, just like Romeo and Juliet, I should commit suicide' or whatever, but that doesn't mean that the person's going to do it," says Rothe.

"That would be very interesting to hear how [the trials] defined suicidal thoughts or ideas. Did [the patients] really feel like they were going to do it?" Rothe asks.

"The follow-up [with patients taking Strattera] needs to be done much more carefully, and that would be my message," he says.

Contact Information

The FDA offers this contact information in its advisory:

Health care professionals are encouraged to report any unexpected adverse events associated with Strattera directly to Lilly at (800) LillyRx or to the FDA MedWatch program at (800) FDA-1088; by fax at (800) FDA-0178; by mail to MedWatch, Food and Drug Administration, HFD-410, 5600 Fishers Lane, Rockville, MD, 20857-9787; or online at www.fda.gov/medwatch/report.htm.

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