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Zyprexa / Olanzapine
Zyprexa, also known as Olanzapine, is manufactured by Eli Lilly & Co. The drug is used in treating schizophrenia, bi-polar disorders and some other psychotic mental disorders. The Food & Drug Administration (FDA) approved Zyprexa's use as a schizophrenia treatment in 1996 and approved the drug for treatment of bi-polar disorder in 2000. Zyprexa, Eli Lilly's top-selling drug ($2.5 billion in sales in 2002), has been prescribed to over 6 million people worldwide since its debut.
The most common side effects of Zyprexa use include, but may not be limited to, drowsiness, weight gain, restlessness, dizziness, increased appetite, constipation and fatigue.
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. Currently, however, no warning exists on Zyprexa's product information recommending that potential users monitor blood glucose levels. Eli Lilly contends that people with schizophrenia are more prone to develop diabetes anyway.
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 Zyprexa side effect that is associated with the use of nearly all antipsychotic drugs. Symptoms of NMS include, but are not limited to, 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. TD may cause patients taking antipsychotic drugs to lose their ability to control voluntary movements and is sometimes irreversible. TD occurs most frequently in elderly women although it can affect anyone.
In 2002, medical journalist and author Robert Whitaker published a report revealing eye-opening clinical trial data for Zyprexa that was allegedly not made available to physicians prescribing the medication. According to Whitaker, 20 of the 2,500 patients who took part in Zyprexa trials died; 20 committed suicide; and 22 percent suffered a serious adverse event. Two-thirds of the patients did not complete the trial.
Furthermore, off-label Zyprexa use is a growing problem in the medical community. Physicians continue to prescribe the medication for "off-label" symptoms such as anxiety and depression, even though the drug has not been FDA-approved to treat the conditions. Off-label users may increase their risk of developing a negative side effect because the drug has not been properly tested to treat these disorders. In July 2003, the FDA approved Zyprexa for use with lithium or depakote to treat bipolar mania.
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 March 2004, Britain's Committee on Safety of Medicines warned physicians that elderly patients taking Zyprexa to treat dementia, an off-label use, face three times the risk of suffering a stroke. The FDA and Lilly also 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.
See your doctor if you have experienced serious health problems due to Zyprexa side effects. In addition, it may be important to contact an attorney who can help you protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit.
Napoli Kaiser Bern Zyprexa clients will find professional representation and devoted lawyers that Napoli Kaiser & Bern is known for at the new and distinct firm - Napoli Bern, LLP. The team at Napoli Bern has years of experience in prosecuting defective-drug actions on behalf of their clients.
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