FDA Denies Expanded Use of Xgeva Pending Clinical Trial

Posted on April 30, 2012

The Food and Drug Administration has voted to deny an expansion of a drug currently on the market due to the dangers that might be posed by the new function that the drug’s makers were hoping to market it for.

Xgeva, a drug made by Amgen, has since 2010 been used to prevent bone injuries related to cancer.  But recently, the makers of the drug petitioned the FDA to allow the drug to go to market for a stated use of preventing bone metastases in those persons suffering from prostate cancer resistant to castration.  The FDA has denied that request, saying that an additional clinical trial would be needed.

In February, the Oncologic Drugs Advisery Committee came to a 12 to 1 conclusion that the benefits of this added treatment would not outweigh the risks.  It was discovered that such usage entailed a 5% risk that a patient would suffer some complications in their bones, compared with a 15% lower risk of the aforementioned metastases.  This, combined with no demonstrable effect on survivability of the disease, led to their decision.

I pay close attention to these kinds of developments as a personal injury attorney in San Jose.  With so many drugs coming to market, someone in a position such as mine has to be well versed in the dangers that certain drugs might pose to a consumer.  I hope as a Bakersfield personal injury lawyer that all drugs are guaranteed safe before they’re bestowed upon the general public.

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