Zyprexa: Rampant Off-Label Use

Brooklyn, NYYet another example of an anti-psychotic drug allegedly presenting links to diabetes and weight gain is Zyprexa, manufactured by Eli Lilly & Co. and prescribed for the treatment of schizophrenia and bipolar mania.

However, patients may be getting more than they bargained for, with the possibility of hyperglycemia, diabetes, blood sugar disorders and pancreatitis. And while patients currently prescribed Zyprexa for approved conditions should never abruptly stop taking the medication without consulting a physician, the fact remains: Zyprexa may present certain side effects that you might just as soon not have.

It's a major concern - and not a new one either, if the events of the last few years have any indication.

For example, the Japanese Health and Welfare Ministry, and the Great Britain Medicines Control Agency issued warnings regarding Zyprexa and diabetes-related complications. That was in 2002, and a year later the U.S. Food and Drug Administration (FDA) ordered an upgrade to the Zyprexa warning label for product sold in the United States, to include reference to a risk for hyperglycemia.

If you are currently taking Zyprexa, rest assured that the drug is still considered safe and effective for the treatment of that for which it was approved in the first place - schizophrenia, and bipolar disorder.

However, there has been a fair bit of off-label activity going on, and not all of it, apparently, at the behest of doctors. And if you have yet to hear about any concerns linking Zyprexa with the onset of diabetic disorders, it's because the manufacturer allegedly did its best to keep that characteristic of the drug quiet.

According to the Harvard Medical School, off-label use of Zyprexa accounts for about 2% of its sales. Even though it is illegal for the manufacturer to market the drug for use beyond the treatment of schizophrenia and some bipolar disorders, doctors can legally use their own discretion in prescribing and advising patients.

In another case of Eli Lilly maximizing its product usage, the drug company tried to get FDA approval for the use of Zyprexa for dementia in elderly patients. But the data from clinical trials exposed a heightened risk of death and stroke in patients taking the drug.