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(Ivanhoe Newswire) -- Many biological medicines, including antibodies, vaccines and insulin, are approved each year; but a quarter of them are later cited for safety issues.
Biologicals, or medicines created from living organisms, are a growing part of medical treatment. More than 250 biologicals have been approved since 1982. They represent 24 percent of all new medicines approved in the United States between 2003 and 2006; but concerns surrounding their risks have landed them in the hot seat.
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From 1995 to June 2008, researchers in the Netherlands examined 174 biological medicinal products approved in either the United States or Europe. During that time, safety-related regulatory actions were made against 41 of the biologicals (23.6 percent), including 19 black box warnings for serious health hazards. Researchers reported none of the treatments were withdrawn for safety reasons. Most of the safety actions were made within five years of the drugs approval.
Health care professionals should be aware of the specific risks related to the relatively new class of biologicals to be able to provide a link between the use of the biological and the patient presenting with a clinical problem, study authors wrote.
Researchers say many of the safety-related regulatory actions may be related to the drugs mode of delivery. Most biologicals, they say, are given intravenously or by injection, which can cause infusion reactions.
SOURCE: JAMA, 2008;300:1887-1896
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