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Nearly a fourth of widely
used new-generation biological drugs that treat several common diseases
produce serious side effects that lead to safety warnings soon after
they go on the market.
The new study, by Dutch
researchers, is the first comprehensive examination of these newer
medicines. It involved 136 biologics approved in the U.S. and 105
in the European Union between January1995 and June 2007. A total
of 41, or nearly 24 percent, got safety warnings issued through
June 2008.
Included in the report
released in October 2008, were the arthritis drugs Humira and Remicade,
cancer drugs Rituxan and Erbitux, and the heart failure dug Natrecor.
Among the drugs under
examination are the drug Raptiva, which the U.S. Food and Drug Administration
warned may contribute to a life-threatening brain illness and infections;
and Exubera, an inhaled insulin product, linked with lung cancer
risks, and which was approved by the FDA in 2006 but Pfizer Inc.
stopped selling it in 2007.
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The lead author Thijs
Giezen of the university of Utrecht said that the results are a
concern, and they underscore the need for closer scrutiny of drugs
after their approval, but it is also reassuring because most problems
showed up relatively soon after the drugs became available, which
minimized the potential for widespread harm.
Dr. Charles Bennett,
a Northwestern University drug safety expert, who was not involved
in the study, said that many of these drugs are genetically engineered
and because they typically resemble naturally occurring proteins,
many doctors have assumed they were safer than traditional chemical-based
medicines. He said the results of the study, simply show that doctors
and patients should be aware that the drugs have many potential
side effects that may not be listed on the label.
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