Eli Lilly and Co. on Friday said it has warned doctors that its schizophrenia treatment Zyprexa, its best-selling drug, significantly raises the risk of death and stroke in elderly patients suffering from dementia.
The Indianapolis-based company said it sent a letter to U.S. doctors on Jan. 15 warning that Zyprexa, which had global sales of $4.3 billion in 2003 and accounts for half of Lilly’s profit, increased the risks in five clinical trials among elderly patients with dementia.
“I don’t think we have a sense of why,” said Lilly spokesman Dan Collins. Higher stroke and death risks have not been seen in other populations, he said.
Similarly, Johnson & Johnson last April warned U.S. doctors that its own schizophrenia drug, Risperdal, raises the risk of stroke among elderly patients with dementia.
Drugs widely used in treating dementia patients
Zyprexa and Risperdal, J&J’s second-biggest drug with 2003 sales of $2.5 billion, are widely used to control behavioral disorders among dementia patients, such as delusions, aggression and anxiety.
Lilly’s warning letter said 3.5 percent of elderly patients with dementia taking Zyprexa in the trials died of all causes, more than twice the death rate of 1.5 percent seen among those taking placebos.
Public Citizen, a consumer watchdog group, has criticized doctors for routinely prescribing schizophrenia drugs to treat symptoms of dementia, including Alzheimer’s disease, even though the medicines are not approved for that use.
Doctors may legally prescribe drugs for uses not approved by the U.S. Food and Drug Administration, although drugmakers are allowed to market their products only for specifically approved uses.
Some doctors have defended such “off-label” use of schizophrenia drugs, saying it would be hard for many dementia patients to live at home without them and that the increased risk of stroke must be balanced against the higher quality of life the medicines may provide.
Collins said Lilly could not advise doctors whether to prescribe Zyprexa for dementia because it is not officially approved for that use by U.S. regulators.
“It is the professional judgment of doctors how they monitor medicines,” said Collins. He said about 2 percent of Zyprexa sales are for elderly patients with dementia.