This inquiry revolves around the pediatric use of the drugs to investigate any relationship to the development of cancer.  In a related story, another pharma company is working with the FDA on a safety study produced in Europe with adverse effect reported, so the approval in Europe with additional statistics may delay the some of the future action of the FDA here as well.  Warning labels may be the ultimate outcome once all the relative information can be evaluated.  BD  image

Sometimes rare safety issues with one or two drugs can sink the fortunes of other drugs in the same class of therapies. Yesterday, the FDA issued a communication that it was looking into possible safety issues with some of the best-selling biopharmaceuticals on the market.

TNF-inhibitor-based drugs on the market include Amgen (Nasdaq: AMGN) and Wyeth's (NYSE: WYE) more-than-$3 billion-a-year Enbrel, Johnson & Johnson (NYSE: JNJ) and Schering Plough's (NYSE: SGP) more-than-$3 billion-a-year Remicade, and Abbott Labs' (NYSE: ABT) Humira, which is expected to bring in around $4 billion in sales this year. Needless to say, any reluctance by doctors to prescribe the drugs, or a tightening of FDA restrictions on these compounds' use, could have a very negative impact on some of big pharma's top lines.

Cancer Concerns Fuel FDA Inquiry

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