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A Black Box Warning For Strattera

For the second time in less than a year, the FDA has issued a grave warning for Strattera, the popular drug prescribed for children and adults who have attention deficit hyperactivity disorder (ADHD). This announcement -- reports of suicidal thinking in some patients -- has forced mega-drugmaker Eli Lilly to stamp their ADHD drug with a black-box label.

The new warning comes on the heels of a review of clinical trials that identified small, but very significant risk of suicidal thoughts among patients who took Strattera. Significant, because more than three million patients have been prescribed Strattera since it became available, and 75 percent them are children.

Business analysts expect Lilly to take another hit at the cash register, after a FDA warning late last year that Strattera could cause severe liver damage sent sales downward.

The reason I post reminders about these black-box drug warnings: Many people -- other than informed consumers -- won't notice them. Most consumers take for granted that the FDA is looking out for their health, when, in fact, expert insiders like Dr. David Graham have shown us the agency will do whatever it can to protect the interest of its real partners, the pharmaceutical industry.

MSNBC September 29, 2005

Yahoo News September 29, 2005

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