The FDA has warned doctors that Strattera, a drug used to treat attention deficit hyperactivity disorder (ADHD), can cause suicidal thinking in some children and adolescents. Manufacturer Eli Lilly & Co. responded by announcing that a black-box warning will be added to the drug's label in the United States.
Eli Lilly says that of over 1,300 patients examined in Strattera's clinical trials, five reported having suicidal thoughts, and one attempted suicide. None of the more than 850 patients taking a placebo experienced these effects. There was no evidence of increased suicidal thoughts in adults.
The warning comes as the result of a general FDA review of psychiatric drugs and their possible association with suicide. Last year, the FDA ordered that all antidepressants must bear warnings that they "increase the risk of suicidal thinking and behavior" in children who take them. Strattera, whose sales reached $667 million last year, is the only ADHD drug approved in the United States that is not also a stimulant, making it a popular choice.
This is the second time in less than a year that the FDA has issued a grave warning for Strattera. While this most recent warning only applies to children and adolescents, bear in mind that of the more than 3 million patients who have been prescribed Strattera since it became available, 75 percent of them are children.
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 partner, the pharmaceutical industry.