Johnson & Johnson plans to contact thousands of U.S. physicians advising them of a possible increased risk of stroke among elderly patients taking its well-known antipsychotic drug risperi-done (Risperdal®). The company might also change the package insert label of the medication, which has annual global sales of $2.1 billion, to note a possible risk of stroke.
In October 2002, the company had sent a similar warning letter to Canadian physicians and pharmacists citing 37 reports of stroke or related events such as blood clots and hemorrhages, including 16 deaths, among patients who had taken Generic Risperdal.
The company also cited two clinical trials in which a higher proportion of elderly patients with dementia taking Risperdal® experienced strokes or related events than patients who took placebo. J&J did note, however, that the elderly are generally at increased risk of stroke.
Although this drug has been approved only for schizophrenia, it is widely used to control behavioral disorders in elderly patients with dementia and Alzheimer’s disease, such as delusions, aggression, and anxiety.
Risperdal® and rival schizophrenia drugs already include information in their labels about strokes that have been observed in patients taking them in either clinical trials or after the drugs reached the market. The labeling for Risperdal® will be changed, however, to include more specific information about strokes in the elderly.
Some think that physicians might be hurting patients by using Risperdal® to treat dementia, and they suggest that the incidence of stroke among elderly Alzheimer’s patients should spur U.S. regulators to further examine whether younger schizophrenia patients are also prone to stroke.
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Others feel that it would be impossible for many patients with dementia to live at home without this drug. Dr. Norman Sussman, a professor of psychiatry at New York University Medical Center, for instance, says that physicians must weigh the possibly higher stroke risk associated with Risperdal® against the higher quality of life it offers to patients with dementia.