1 in 4 new bio meds cause serious side effects

1 in 4 new bio meds cause serious side effects

CHICAGO - 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, the first major study of its kind found.

Included in the report released Tuesday were the arthritis drugs Humira and Remicade, cancer drugs Rituxan and Erbitux, and the heart failure drug Natrecor. All wound up being flagged for safety.

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The new study, by Dutch researchers, 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. These can include brain and fungal infections and cancer.

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Concerning results

Among the drugs under examination are Genentech Inc.’s psoriasis drug Raptiva, which just last week the 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. Exubera was approved by the FDA in 2006 but Pfizer Inc. stopped selling it last year.

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.

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For example, non-steroid arthritis medicines including ibuprofen can reduce pain by decreasing inflammation, but they can cause stomach bleeding.

Biologic rheumatoid arthritis medicines Remicade, Enbrel and Humira are designed to ease painful joints by keeping the body’s immune system from attacking itself, the underlying problem in the disease. But they are much more expensive and have been linked with higher risks for potentially fatal infections. Also, the FDA is investigating possible cancer risks.

http://www.msnbc.msn.com/id/27294158/

Sam,

It is scary, isn't it? I would like to see more study done on new drugs being introduced to combat illnesses that are already well controlled by other drugs, like Exubera.

However, I hate to see drugs for people battling diseases we don't have good tools for combating further delayed. If you're dying of cancer, or MLS, or MS, I think patients be well informed and make decisions for themselves.

Anyway, that's my $0.02.