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<Home> <Newsletter> <Second Issue> <Genetic Engineering> <Fourth of Biotech drugs carry serious side effects>

Main Topic: C) GENETIC ENGINEERING

Fourth of Biotech drugs carry serious side effects

 

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.

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.

To read more about this subject, you may go to:
www.foxnews.com/story/o,2933,442208,00.html

 

       
     
IOMS Newsletter - 12 August 2009  
Issue No. 002/09
 
 
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