Healthy Skepticism Library item: 1045

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Pierson R.
Stroke risk cited in widely used drug
Reuters 2003 Apr 11
http://web.archive.org/web/20030422094006/http://www.boston.com/dailyglobe2/101/nation/Stroke_risk_cited_in_widely_used_drugP.shtml

Full text:

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.