One in four biologics gets safety warning

New generation biologics are raising some red flags on the safety side. According to a new study, nearly one in four new biological drugs end up bearing serious safety warnings. Serious side effects typically raise their heads within five years after these drugs hit the market, the researchers found. The survey might confound some doctors who consider biologics to be safer than traditional meds.

One reason these biotech drugs result in side effects is that many of them work by suppressing the body's immune system. That way, brain and fungal infections can sneak in. The report specifically mentions Abbott Laboratories' Humira and Schering-Plough and Centocor's Remicade--both of which treat rheumatoid arthritis and other autoimmune diseases. Both also bear safety warnings, including a "black box" infection warning added to the labels last month.

Also mentioned are Genentech's Rituxan and Erbitux, from Bristol-Myers Squibb and ImClone. (Generally thought of as cancer meds, they are also used for other conditions, too.) Genentech just revised Rituxan's label after a man died of the rare but potentially fatal brain infection PML.

That's not to say that traditional meds don't get dinged with safety warnings, too. But the Associated Press couldn't find any similar studies for comparison.

- read the story in the Boston Globe

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