FDA sharpens Zyprexa warning for teens

Two Zyprexa-related events last week underscore the difficulties--and opportunities--Eli Lilly faces with the antipsychotic drug. First, the FDA announced that weight gain and metabolic problems are more prevalent in adolescents taking Zyprexa than they are in adults. The warning comes after a study published last fall showed that children and adolescents who went on Zyprexa gained an average of 17 pounds in 12 weeks, the Los Angeles Times reminds us.

Second, the company reported earnings, stating that in 2009 it spent $693 million on costs related to Zyprexa litigation, much of which centers on allegations that it failed to warn patients of the drug's links to weight gain and, allegedly, diabetes.

This is something of an "it could be worse" story: As BNet Pharma points out, Wall Street looks at that $693 million in legal spending and sees a decrease from $1.9 billion year-over-year. So, Lilly's shelling out less to defend and/or settle Zyprexa cases than it had been; given the big marketing settlement with the U.S. Justice Department last year, that's understandable.

And, too, the FDA could have worded its cautionary tale more strongly, issuing a flashing red light rather than a yellow one. "When deciding among the alternative treatments available ... clinicians should consider the potential long-term risks," the agency advises, "... and in many cases this may lead them to consider prescribing other drugs"--i.e., not Zyprexa--"first in adolescents."

- read the FDA alert
- get more from the LA Times
- see the BNet post

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