Zyprexa warnings not sufficient
Wednesday, November 19th, 2008Labels on the antipsychotic drug Zyprexa don’t warn patients of all its potential side effects.
That’s according to the FDA which says it is looking into requiring the drugs’s manufacturer, Eli Lilly, to include information about some of the drug’s more recently publicized risks and adverse effects such as weight gain, in children, hyperglycemia, and other metabolic effects.
While Zyprexa—a potent brain tranquilizer that calms hallucinations related to schizophrenia and bipolar mania—is only approved for the treatment of schizophrenia and bipolar disorder, it was marketed for use in milder cases of bi-polar disorder and for dementia.
Also, internal Lilly documents and e-mail messages confirm Lilly marketed Zyprexa off-label. It was later found that Zyprexa can cause severe weight gain and an increase in blood sugar in many patients. According to the American Diabetes Association, Zyprexa is likelier to cause diabetes than most other medicines for schizophrenia and bipolar disorder.
Last month, Lilly, in its ongoing Zyprexa scandal, agreed to pay $62 million to 32 states and Washington, D.C. to settle claims it improperly marketed Zyprexa. CNN reported in an earlier release that, since 2005, Lilly has paid out over $1 billion in liability claims connected to Zyprexa. CNN also pointed out that Lilly faces more problems, including a civil and criminal investigation led by federal prosecutors in Philadelphia.