The
following information is from Eli Lilly and Company. Contact the
company for a copy of any referenced enclosures.
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
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Safety Summary
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