Earlier this year, drug maker Eli Lilly and Co. issued a nationwide
warning regarding the increased risk of stroke and death in elderly
patients taking the company's number one drug, Zyprexa.
Zyprexa is commonly used to treat patients with schizophrenia and some
bipolar disorders. The drug does not have approval from the Food and
Drug Administration for uses beyond these conditions. But doctors may
also routinely prescribe Zyprexa to treat the symptoms of anxiety, delusions,
and aggression in elderly patients with dementia. Even though the manufacturer
cannot market the drug for such use, doctors have the legal power to
use their own discretion in advising patients. This "off-label" use of
Zyprexa accounts for roughly 2% of sales.
Eli Lilly was considering seeking FDA approval for the use of Zyprexa
for dementia in elderly patients. In preparation, the company conducted
clinical trials to establish the safety and effectiveness of the drug.
A review of the data from these trials exposed the increased risk of
death and stroke. In the studies, 3.5% of elderly patients taking Zyprexa
for dementia died of all causes, compared to 1.5% of patients taking
a placebo. Patients taking the drug were also significantly more likely
to suffer a stroke than patients taking a placebo. According to Eli Lilly,
the effectiveness of Zyprexa for treating dementia in the elderly has
not been established.
Despite this news, some doctors continue to defend the use of Zyprexa
for elderly patients. They believe the benefits the drug may bring in
helping patients with dementia live at home longer and lead somewhat
more normal lives outweighs the risks.
Physicians and caregivers for elderly patients with dementia need to have
a conversation about their goals and what treatment option may best suit
the patient's situation.
November 2004 Update
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