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Zyprexa Weight Gain
Side Effect: The information below is based on a clinical trial
database for olanzapine consisting of 8661 patients with approximately
4165 patient-years of exposure. Weight Gain was a significant issue for
those taking Zypresa. In a placebo-controlled, 6-week study, weight gain
was reported in 5.6% of olanzapine patients compared to 0.8% of placebo
patients. Olanzapine patients gained an average of 2.8 kg, compared to
an average 0.4 kg weight loss in placebo patients; 29% of olanzapine
patients gained greater than 7% of their baseline weight, compared to 3%
of placebo patients. A categorization of patients at baseline on the
basis of body mass index (BMI) revealed a significantly greater effect
in patients with low BMI compared to normal or overweight patients;
nevertheless, weight gain was greater in all 3 olanzapine groups
compared to the placebo group. During long-term continuation therapy
with olanzapine (238 median days of exposure), 56% of olanzapine
patients met the criterion for having gained greater than 7% of their
baseline weight. Average weight gain during long-term therapy was 5.4kg.
In March of 2003, it was reported by FDAnews.com that personal injury
attorneys were expected to file up to 10 lawsuits against Eli Lilly
alleging the drugmaker failed to adequately disclose “serious side
effects” associated with its schizophrenia and acute bipolar mania drug
Zyprexa (olanzapine), plaintiffs’ lawyers announced last week. The San
Francisco-based firm Hersh & Hersh recently filed two lawsuits over the
drug and is filing 30 more on behalf of individuals who claim the drug
led to such illnesses as diabetes, hyperglycemia and pancreatitis.
Eli Lilly lists many side effects on their web site, including:
dry mouth, dizziness, and feelings of weakness. Some patients also
reported constipation, upset stomach, increased appetite, or mild
trembling. More significantly, Eli Lilly reports that some people who
have taken ZYPREXA have reported weight gain. Their web site also states
that some people have experienced seizures while taking ZYPREXA and
similar medications.
Zyprexa has been linked to diabetes, hyperglycemia, and neuroleptic
malignant syndrome, carrying fears so great that it led Japan and the
European Union to include warnings about the sometimes-fatal Zyprexa
side effects. In November 2001, the Journal of the American Medical
Association medical officers from the FDA’s Center for Drug Evaluation
and Research and a Duke University Medical Center physician first
reported a possible link between Zyprexa and hyperglycemia in
adolescents. Other FDA staff members then published a report in a
December 2001 American Journal of Medicine linking Zyprexa to diabetes.
Both Zyprexa reports used information from the FDA’s adverse drug
reaction database.
The FDA has identified at least 384 reports of diabetes because of
Zyprexa use, with the majority of cases appearing with six months of
the start date. The Japanese Ministry of Health, Labor and Welfare, as
well as the British medical equivalent to the FDA received reports of
serious hyperglycemia and diabetes amongst Zyprexa patients and issued
warnings accordingly. In the U.S., no such action was taken to warn
physicians and patients of Zyprexa risks.
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