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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 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.org Contact: Vera Hassner Sharav 212-595-8974 e-mail: veracare@ahrp.org
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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
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