Nearly a fourth of widely used new-generation biological drugs for several common diseases produce serious side effects that lead to safety warnings soon after they go on the market. Included in the report were the arthritis drugs Humira and Remicade, cancer drugs Rituxan and Erbitux, and the heart failure drug Natrecor.
The new study is the first comprehensive examination of these newer medicines, a driving part of the biotech revolution. The drugs are known as biologicals because they're made from living material and they typically affect the body's disease-fighting immune system. Many relieve severe symptoms by suppressing that system. It's that same mechanism that can result in side effects often not seen with traditional chemical-based medicines, said Dr. Charles Bennett, a Northwestern University drug safety expert.
The study appears in Wednesday's Journal of the American Medical Association. It involved 136 biologics approved in the United States and 105 in the European Union between January 1995 and June 2007. A total of 41, or nearly 24 percent, got safety warnings issued through June 2008. The results are a concern, and they underscore the need for closer scrutiny of drugs after their approval, Researchers said the study also is reassuring because most problems showed up relatively soon after the drugs became available, which minimized the potential for widespread harm.
Bonnie - it is not reassuring that the problems show up relatively soon after approval. They should be showing up before approval!
This is why I have a "wait 1-2 years rule for new meds."
Tuesday, October 21, 2008
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