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Stroke risk cited in widely used drug

By Ransdell Pierson, Reuters, 4/11/2003

NEW YORK -- Johnson & Johnson said yesterday it will soon send letters to thousands of US physicians advising them of possible increased risk of stroke among elderly patients taking its blockbuster antipsychotic drug Risperdal. A Johnson & Johnson spokeswoman said the company also plans to change the package insert label of the pill, which has annual global sales of $2.1 billion, to note possible stroke risk. ''An update to the Risperdal label is indeed being made, and we will be sending out letters to health-care professionals soon.''

The diversified health-care company last October sent a similar warning letter to Canadian doctors and pharmacists. It cited 37 reports of stroke or related events like blood clots or hemorrhages, including 16 deaths, among patients who have taken its drug. Moreover, the company cited two clinical trials of elderly dementia patients in which ''a higher proportion of patients taking Risperdal experienced strokes or related events than those who received placebo [sugar pills].''

Johnson & Johnson noted in the Canadian warning letter that the elderly are generally at increased risk of stroke. Risperdal is Johnson & Johnson's second-biggest-selling medicine. Although only approved 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 seen in patients taking them in either clinical trials or after the drugs reached the market. Risperdal's label will be changed, however, to include more specific information about strokes in the elderly.

Larry Sasich, a pharmacist and research analyst for consumer watchdog group Public Citizen, said worrisome safety trends have cropped up in various clinical trials that tested Risperdal in Alzheimer's patients. He said 29 cases of stroke and stroke-related events were seen among 764 patients tested in four specific trials, or in about 4 percent of patients, compared with only 2 percent of those who received placebos. ''And there were four deaths among patients taking Risperdal, compared with only one death in those taking placebos,'' Sasich said.

''The Risperdal label clearly states that there is no evidence this drug is safe or effective in treating dementia, and it looks like doctors are hurting people by prescribing it for this condition,'' Sasich said. Sasich said the incidence of stroke among elderly Alzheimer's patients should spur US regulators to further examine whether younger schizophrenia patients are also unacceptably prone to them. ''Public Citizen is ignoring the clinical reality that it would be impossible for many dementia patients to live at home without these drugs,'' said Dr. Norman Sussman, a professor of psychiatry at New York University Medical Center. Sussman said doctors routinely use Risperdal and similar schizophrenia drugs like Eli Lilly and Co.'s Zyprexa to treat dementia symptoms, even though they are not approved for that use.

This story ran on page A6 of the Boston Globe on 4/11/2003