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