What is Zyprexa?

Olanzapine (trade name Zyprexa), belongs to the thienobenzodiazepine group of drugs, which are atypical antipsychotics. Zyprexa is similar to clozapine or resperidone.

What is Zyprexa used for?

Zyprexa is used to treat a wide range of disorders including bipolarism, manic depression, anxiety, schizophrenia and other psychotic conditions. Zyprexa works by inhibiting certain dopamine and serotonin receptors that are believed to be linked to schizophrenia and other psychotic disorders including depression.

When did Zyprexa first come on the market?

Zyprexa won FDA approval in 1996.

What is the treatment involved?

Typically, people begin Olanzapine or Zyprexa treatment in low doses, and increasing them until they reach a therapeutic dose. It is not unusual for people to not see results for some time, until the dosage is increased to the proper levels and the drug has been in a patients system for several weeks. Once the drug is effective it can not be stopped or symptoms will return.

What company makes Zyprexa?

Eli Lilly manufacturers Zyprexa.

What is the problem with Zyprexa?

The drug has been linked to serious physical side effects, such as drastic changes in patients blood sugar levels. The major problem caused by Zyprexa is that some individuals develop diabetes while taking the drug. However, Zyprexa may also cause serious side effects in otherwise healthy patients being treated for mental disorders.

What are common side effects?

The conditions most commonly reported in connection with Zyprexa use have been: diabetes mellitus, pancreatitis, hyperglycemia (elevated blood sugar level), and diabetic ketoacidosis and in some cases Diabetic Coma induced by severe insulin deficiency.

Recent Developments

In September of 2003, the FDA asked Eli Lilly to add a new warning to the popular schizophrenia drug Zyprexa, warning patients that Zyprexa has been linked to diabetes and other blood sugar disorders. In a recent study, Zyprexa and two other atypical antipsychotics that are used to treat schizophrenia were found to cause diabetes 50 percent more often than older drugs. Last year, Britain's Medicines Control Agency warned that several patients taking Eli Lilly's top selling drug Zyprexa (used to treat schizophrenia) had developed diabetes-related complications. In the Medicine Control Agency's Current Problems newsletter, the regulatory body said that the antipsychotic drug "can adversely affect blood glucose."

Forty reports "of hyperglycemia (elevated blood sugar), diabetes mellitus, or exacerbation of diabetes have been received in the UK. Four were associated with ketoacidosis and/or coma including one with a fatal outcome," according to the newsletter. "The precise mechanism of this suspected adverse drug reaction has not yet been elucidated and is currently being investigated further.

This follows an emergency report issued in April 2002 by the Japanese Health and Welfare Ministry to Eli Lilly Japan KK concerning side effects of Zyprexa after the deaths of two diabetic users of the drug. It said seven other patients had lost consciousness or become comatose after taking the drugs in the last 10 months. The Japanese Ministry said no new diabetes patients should be treated with the drug and ordered Eli Lilly to warn doctors to closely monitor diabetics already on the medication.

In July 2002 a study at Duke University further showed a connection between Zyprexa and diabetes. The study documented nearly 300 cases of diabetes in people using Zyprexa, with many of the cases developing within 6 months of Zyprexa use.

A paper written in late 2001 in the Journal of Clinical Psychiatry reports the FDA has been alerted 19 case reports of diabetes associated with the use of Zyprexa. Of the 19 patients seven had newly diagnosed hyperglycemia. The sugar disorder developed within a week of taking Zyprexa in two patients and within six months for eight others. One patient ultimately died of necrotizing pancreatitis, a condition in which cells in the pancreas die.

What are the early warning signs of diabetes?

Abnormal thirst and a dry mouth • Frequent urination • Nausea or vomiting • Rapid breathing • Extreme fatigue or lack of energy • Constant hunger • Slow-healing wounds • Recurrent infections • Blurred vision Specifics of the Zyprexa Studies:

On July 1, 2002, Duke University issued a Press Release about the most recent finding that links the new anti-psychotics to early onset diabetes. The team of researchers--Elizabeth A. Koller, M.D. from the FDA, and Murali Doraiswamy, M.D. from Duke-- analyzed FDA's adverse drug report database, MedWatch (which receives 10% of adverse drug reports). They identified 289 cases of diabetes in patients who had been prescribed olanzapine (a.k.a. Zyprexa), Eli Lilly's most profitable drug.

The researchers reported: "Of the 289 cases of diabetes linked to the use of olanzapine, 225 were newly diagnosed cases. One hundred patients developed ketosis (a serious complication of diabetes), and 22 people developed pancreatitis, or inflammation of the pancreas, which is a life- threatening condition. There were 23 deaths, including that of a 15-year- old adolescent who died of necrotizing pancreatitis, a condition where the pancreas breaks down and dies. Most cases (71 percent) occurred within six months of starting the drug and many cases were associated with moderate weight gain." The evidence from pre-marketing trials was also alarming: Whitaker wrote: " Of the 2,500 patients in the trials who received olanzapine, twenty died. Twelve killed themselves...Twenty-two percent [ ] suffered a 'serious' adverse event, compared to 18 percent of the haloperidol patients. Two- thirds of the olanzapine patients didn't successfully complete the trials...."(p. 281) According to the Duke researchers, many cases of diabetes have also been reported with other antipsychotic drugs. In 1994, a Duke team first reported a Diabetes link to the first 'atypical' antipsychotic drug, clozapine: last year, 384 reports of diabetes last year were associated with clozapine. Whereas the British Medical Control Agency and the Japanese Health & Welfare Ministry have issued warnings about the risk of diabetes for patients prescribed Zyprexa, FDA has remained silent. It is astounding to AHRP that the FDA has approved a clinical trial that exposes teenagers-- who are not even diagnosed with schizophrenia-- to a drug that puts them at risk of diabetes. The trial is being conducted at Yale University. [See, AHRP complaint filed with the federal Office of Human Research Protection at: http://www.researchprotection.org/Initiatives/YaleComplaint.html

If you or a family member have suffered serious side effects or a fatal injury after ingesting a dangerous prescription drug, you or the family member may be eligible to file a claim against the manufacturer. Call our team of professional attorneys at Dyer, Garofalo, Mann & Schultz for a FREE consultation, or complete our online form..

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