Fast facts about Zyprexa
By ROB FARLEY
Published December 16, 2007
Generic name: olanzapine
Manufacturer: Eli Lilly and Co.
FDA approval: 1996, for adults suffering from schizophrenia, and later for bipolar disorder.
"Off label" uses: Doctors prescribe it for depression, anxiety, ADHD and eating disorders, and as a sleep aid.
Common side effects: weight gain, sleepiness, constipation, dry mouth, increased appetite, feeling weak, indigestion, tremors (shakes) and dizziness.
Current status: Lilly has asked the FDA to approve Zyprexa for adolescents, 13 and older, with schizophrenia or bipolar disorder. The head of the FDA's Division of Psychiatric Products has recommended approval.
Lilly's take: Approval would address an unmet need for adolescents suffering from devastating disease. Says spokeswoman Carole Witsken Puls: "Physicians are in the best position to evaluate the benefits and risks of potential treatment options for their individual patients."
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Zyprexa in court
Individual claims: Over the past two years, Eli Lilly has paid $1.2-billion to settle lawsuits from some 30,000 people, most of whom claim Zyprexa caused them to develop diabetes. Hundreds more cases are pending.
Lilly's take: Only a small number of those who gain weight on Zyprexa develop diabetes, which can be caused by family history, lifestyle and diet. No data establishes causation between Zyprexa and diabetes.
The company's medical director, Sara Corya, says the focus on weight gain and diabetes distracts from just how devastating bipolar disorder and schizophrenia can be. People suffering these illnesses are often homeless, psychotic. "Some can't distinguish between reality and the voices they are hearing in their heads."
Those realities need to be balanced against the possible side effects. Zyprexa has been a lifesaving medication for millions of people.
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State claims: Nine states have sued Eli Lilly claiming the company promoted Zyprexa for off-label uses and downplayed its risks. Each state wants to be reimbursed hundreds of millions of dollars in Medicaid dollars paid for Zyprexa.
Florida has not sued and won't comment, though Eli Lilly has said that it received a subpoena in 2005 from the state's Medicaid Fraud Control Unit, seeking documents related to the sales, marketing and promotional practices of Zyprexa.
Lilly's take: The company is cooperating with the investigations. It does not promote off-label uses or downplay the side effect risks.
"The information on weight gain and blood glucose levels has been on the label since it was approved in 1996," says spokeswoman Marni Lemons.
In the 11 years since, there have been 28 label updates to Zyprexa as new information emerged. "We've worked hard to keep physicians, patients and caregivers informed about any side effects of Zyprexa."