Zyprexa is an antipsychotic medication that works by changing the
actions of chemicals in the brain. Zyprexa is used to treat the symptoms
of psychotic conditions such as schizophrenia and bipolar disorder. Zyprexa
may also be used for other purposes.
Zyprexa Has Side Effects
Dizziness, somnolence, dry mouth, dyspepsia, constipation, ALT (SGPT) increased,
personality disorder, increased appetite, weight gain, akathisia, asthenia,
tremor, postural hypotension. Rare cases of Priapism and leukopenia.
Zyprexa has been linked to an increased risk of diabetes.
There have been 288 reported diabetes cases in Zyprexa patients, with 23 of
them being fatal.
A class action Zyprexa lawsuit accuses Lilly & Co., the manufacturer of Zyprexa of
aggressively promoting Zyprexa as a safe and effective drug for psychotic
disorders, while concealing the risks of side effects from doctors and from
the patients.
The Japanese Health and Welfare Ministry and the Great Britain Medicines Control
Agency issued emergency warnings concerning Zyprexa and diabetes-related complications.
British Medical Journal Study - British Medical Journal assessment of independent
effect of olanzapine (the trade name of Zyprexa) and risperidone on risk of diabetes among patients
with schizophrenia
Patients should understand that it could be dangerous to stop taking any medication including Zyprexa,
especially abruptly, and should talk with their physicians to decide whether
the benefits and risks of taking Zyprexa is appropriate for them.
National Institute for Mental Health on Antipsychotic Medications
Important Zyprexa News
Eli Lilly & Company, the maker of the Zyprexa drug has set aside $690 million
to pay patients who took Zyprexa before September 2003 and suffered damages.
Injuries that may be compensated under the fund include:
Diabetes
Pancreatitis
Diabetic Coma
Ketoacidosis
Hyperglycemia
Also this notice was posted by the FDA:
March 1, 2004
Re: Safety data on Zyprexa ® (olanzapine) - Hyperglycemia and Diabetes
Dear Doctor,
Eli Lilly and Company would like to inform you of important labeling changes regarding Zyprexa (olanzapine). The Food and Drug Administration (FDA) has asked all manufacturers of atypical antipsychotic medications, including Lilly, to add a Warning statement describing the increased risk of hyperglycemia and diabetes in patients taking these medications, including Zyprexa. In addition to Zyprexa, the atypical antipsychotic class includes Clozaril ® (clozapine, Novartis), Risperdal ® (risperidone, Janssen), Seroquel ® (quetiapine, AstraZeneca), Geodon ® (ziprasidone, Pfizer), and Abilify ® (aripiprazole, Bristol Myers Squibb and Otsuka American Pharmaceutical). Accordingly, the Zyprexa prescribing information has been updated with the following information:
WARNINGS
Hyperglycemia and Diabetes Mellitus
Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics including Zyprexa. Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population. Given these confounders, the relationship between atypical antipsychotic use and hyperglycemia-related adverse events is not completely understood. However, epidemiological studies suggest an increased risk of treatment-emergent hyperglycemia-related adverse events in patients treated with the atypical antipsychotics. Precise risk estimates for hyperglycemia related adverse events in patients treated with atypical antipsychotics are not available.
Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control. Patients with risk factors for diabetes mellitus (e.g., obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug.
Should you have any questions or concerns regarding this important safety information, please contact your Eli Lilly and Company sales representative or contact the Lilly medical department at 1-800-Lilly-Rx . Please refer to the full prescribing information for Zyprexa included with this letter. As always, we request that serious adverse events be reported to Lilly at 1-800-Lilly-Rx or to the FDA MedWatch program by phone (1-800-FDA-1088 ), by fax (1-800-FDA-0178 ) or by email (www.fda.gov/medwatch).
Sincerely,
Dr. Paul Eisenberg
Vice President, Global Product Safety
Eli Lilly and Company