Zyprexa - Olanzapine

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Modified on 2010/09/13 07:35 by Chrissie Cole
Zyprexa Drug Information

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Zyprexa , known generically as olanzapine, is manufactured by Eli Lilly & Co.  This drug is an atypical antipsychotic indicated for the treatment of schizophrenia and bipolar disorder.  The Food and Drug Administration (FDA) approved Zyprexa for use as a schizophrenia treatment in 1996, and approved the drug for treatment of bipolar disorder in 2000.  The most common side effects of Zyprexa include drowsiness, weight gain, restlessness, dizziness, increased appetite, constipation and fatigue.

Zyprexa Advisory Information

Zyprexa has been associated with pancreatitis. Zyprexa is also linked to the development of two very serious illnesses, Neuroleptic Malignant Syndrome (NMS) and Tardive Dyskinesia (TD). NMS is a potentially fatal side effect associated with the use of nearly all antipsychotic drugs. Symptoms of NMS include acute kidney failure, body temperature in excess of 106 degrees (hyperpyrexia), rigid muscles, irregular pulse or blood pressure, rapid heart beat (tachycardia), and irregular heartbeat. Tardive dyskinesia may cause patients taking atypical antipsychotics to lose the ability to control voluntary movements, and is sometimes irreversible. TD occurs most frequently in elderly women, although it can conceivably affect anyone.

The FDA and Lilly have notified healthcare professionals of a revision to the WARNINGS section of Zyprexa labeling, describing the increased risk of hyperglycemia and diabetes in patients taking Zyprexa. FDA has asked all manufacturers of atypical antipsychotic medications, including Lilly, to add this Warning statement to labeling.

Zyprexa History

2010

On September 10, a federal appeals court threw out a class certification against Eli Lilly & Co. over Zyprexa. The US Second Circuit Court of Appeals found that a lower court judge erred in certifying a class of insurance companies and other third-party payers in 2008.

The third-party payers alleged in part, that they overpaid for Zyprexa, as a result of misrepresentations by Lilly regarding the safety and efficacy of the drug – namely it was more effective than other similar drugs.

February 2008

The FDA approved Eli Lilly's extended release injectable form of olanzapine, termed Zyprexa Adhera.  This formulation of  the antipsychotic was developed to treat mentally ill patients who have problems consistently taking Zyprexa by oral administration.  Adhera is a once or twice monthly shot of extended release olanzapine that precludes the need for a daily regimen of Zyprexa tablets.  The FDA reported more substantial risk of profound sedation with Zyprexa Adhera than with other forms of Zyprexa, including Symbyax.

September 2007

In 2007, the Institute for Safe Medication Practices and the Division of Public Health Sciences, Wake Forest University School of Medicine, conducted a longitudinal Adverse Events Reporting System Review of the U.S. FDA's most dangerous drugs. The study found Zyprexa to be one of the most dangerous drugs on the market with some of the highest number of suspect drug deaths.  Zyprexa was the thirteenth deadliest drug in the study, according to the FDA reports.  Over the eight years of the dangerous drug study, Zyprexa was found to have been involved in over 1,000 deaths in an 8-year period.

June 2007

In June 2007, Eli Lilly made settlements worth hundreds of millions of dollars to settle three-fourths of outstanding personal injury claims for alleged diabetes and pancreatitis caused by Zyprexa.  In the same year, Lilly sought permission from the FDA to market Zyprexa as a treatment for schizophrenia in adolescents.


January 2004

In January 2004, Eli Lilly issued a warning to physicians stating that Zyprexa was linked to a significantly higher risk of stroke and death when used by elderly patients.  In addition, the company modified the drug's warning label to reflect heightened risk of diabetes mellitus and hyperglycemia.


August 2003

A July 2002 Duke University study revealed the link between Zyprexa and the onset of diabetes. Nearly 300 cases of diabetes were identified in the study, most occurring within six months of starting Zyprexa treatment. In August 2003, researchers with the Department of Veterans Affairs, Boston University and the University of Illinois at Chicago released findings from a study conducted on three antipsychotic medications, including Zyprexa, that also linked the drug to an increased rate of diabetes. Numerous other studies have linked Zyprexa use with serious diabetic conditions, including diabetic coma, caused by severe insulin deficiency.

Drug Injury

Please consult with your physician about any questions you may have concerning Zyprexa. If you are experiencing any of the side effects mentioned above, it may be important for you to discuss treatment alternatives to your current medication.  You should never stop taking any medication before first consulting with your primary care physician. 



See Also

  1. Antidepressants & Other Psychiatric Drugs
  2. Diabetes
  3. Neuroleptic Malignant Syndrome
  4. Pancreatitis: Overview
  5. Stroke
  6. Tardive Dyskinesia
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