A black box warning is the most severe warning that the FDA can place on a product without withdrawing it from the market.
The FDA began analyzing the drugs, known as tumor necrosis factor (TNF) blockers, when reports emerged that dozens of children had developed cancer while taking the drugs. TNF blockers are used to treat inflammatory and autoimmune diseases such as Crohn's disease and rheumatoid arthritis. They include adalimumab (marketed as Humira), certolizumab pegol (marketed as Cimzia), etanercept (marketed as Enbrel), golimumab (marketed as Simponi) and infliximab (marketed as Remicade.'
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Interesting, but how many people actually read the warnings on the leaflet enclosed within the box?
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