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Dangerous deception--Hiding the evidence of adverse drug effects

Article Abstract:

The New York Times reported on September 30, 2006 that the Food and Drug Administration had issued a warning that the antifibrinolytic drug aprotinin widely used to reduce perioperative bleeding in patients undergoing cardiac surgery, could cause renal failure, congestive heart failure, stroke, and death. In a study involving 4374 patients who underwent coronary revascularization it was found that patients who were given aprotinin had an incidence of postoperative renal failure requiring dialysis that was more than twice that among patients who received different agents.

Author: Avorn, Jerry
Publisher: Massachusetts Medical Society
Publication Name: The New England Journal of Medicine
Subject: Health
ISSN: 0028-4793
Year: 2006
Complications and side effects, Risk factors, Stroke (Disease), Stroke, Heart failure, United States. Food and Drug Administration, Antifibrinolytic agents

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Keeping science on top in drug evaluation

Article Abstract:

The article reviews the drug-approval procedures followed in the U.S. relevant to science and vested interests of pharmaceutical companies.

Author: Avorn, Jerry
Publisher: Massachusetts Medical Society
Publication Name: The New England Journal of Medicine
Subject: Health
ISSN: 0028-4793
Year: 2007
Product development, Pharmaceutical preparations, HEALTH SERVICES, All Other Miscellaneous Ambulatory Health Care Services, Disease Testing Programs, Methods, Usage, Drugs, Pharmaceutical industry, Science, Scientific method, Drug evaluation

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Subjects list: United States
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