April 11, 2003:
Risperdal Linked to Stroke
Two highly promoted, best selling neuroleptic drugs (also
called, antipsychotics) are linked to life-threatening drug-induced
conditions. The Boston Globe reports (below) that elderly people who are
prescribed Risperdal are at increased risk of stroke. The manufacturer,
Johnson and Johnson, sent letters of warning to Canadian physicians and
pharmacists last October, citing “37 reports of stroke or related events like
blood clots or hemorrhages, including 16 deaths, among patients who have taken
its drug. “
However, the company has not yet sent out similar warning letters to U.S.
healthcare professionals. Johnson & Johnson announced that ''An update to the
Risperdal label is indeed being made, and we will be sending out letters to
health-care professionals soon.'' Why the delay? What about warnings in their
advertisements that reach patients directly?
The Wall Street Journal reports (abstract below) that warnings have been
issued all over the world--except the U.S.— about the high risk of diabetes
for patients prescribed Eli Lilly’s Zyprexa. FDA's own expert team had
gathered information about the possible link between atypical antipsychotics
and diabetes. However, the WSJ reports, "Officials with the division say that
in recent years, they have gradually moved away from requiring manufacturers
to warn about "possible" side effects. The division now aims, instead, to
define risks with more certainty, the officials say."
As we all know, there is almost never certainty about a drug's causal adverse
effect. But there one can infer a probability when it occurs with regularity.
Perhaps the FDA's reluctance to warn the public about potential danger from
best selling drugs, is the agency's commitment to protect the profit margin of
drug companies such as Eli Lilly--even if the drug puts patients lives at
risk.
See also: Duke Warning Zyprexa-Diabetes link at:
http://www.ahrp.org/infomail/0702/12b.html
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
http://www.ahrp.or
Contact: Vera Hassner Sharav
212-595-8974
e-mail: veracare@ahrp.org
http://www.boston.com/dailyglobe2/101/nation/Stroke_risk_cited_in_widely_used_drugP.shtml
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.
© Copyright 2003 Globe Newspaper Company.
Drug Debate: New Antipsychotics Pose a Quandary For FDA, Doctors --- Eli
Lilly's Big Seller, Zyprexa, Can Help Schizophrenics; Is It Linked to
Diabetes? --- Warnings Abroad, Not in U.S.
Wall Street Journal
Apr 11, 2003;
By Geeta Anand and Thomas M. Burton;
Start Page: A1
Abstract:
The young woman was hospitalized for a week and released, still taking
Zyprexa, in addition to insulin, which controls blood-sugar levels. Dr.
[Thomas Johnson] says that neither he nor doctors at the hospital initially
considered any potential connection between Zyprexa and the patient's
blood-sugar problem because the drug's label lacks any alert on the topic.
After he found reports on the Internet about the drug and diabetes, he took
the patient off Zyprexa. Her blood sugar returned to normal, he says.
A team of researchers, led by Elizabeth Koller, a former FDA official, and Dr.
[P. Murali Doraiswamy] of Duke, catalogued the number of diabetes-related
complications reported to the FDA in patients taking Zyprexa and Risperdal,
the drug made by Johnson & Johnson unit Janssen Pharmaceutica. The researchers
reported the possible Zyprexa side-effect cases last July in the journal
Pharmacotherapy: Over an eight-year period, 288 diabetes cases, of which 75
resulted in severe illness and 23 in death. Of the millions who had taken
Risperdal over an overlapping nine-year period, Dr. Koller's group found 132
diabetes cases, 31 of which involved life-threatening complications and five
that ended in death. The findings were based on voluntary reports to the FDA,
which scientists estimate reflect between 1% and 10% of actual cases.
Robert W. Baker, a senior clinical research scientist at Lilly, says the
company has spent millions of dollars on research evaluating the diabetes
question. Roughly a quarter of Zyprexa patients gain more than 25 pounds while
on the medication, Lilly researchers say, and obesity! is linked with
diabetes. But Dr. Baker says the evidence suggests Zyp rexa itself doesn't
cause diabetes-related problems. He says the research suggests that the
Zyprexa patients who developed diabetes probably had elevated blood-sugar
levels before taking the medication.
Last Updated on
04/14/04
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