According to a press conference given by the Food and Drug Administration Commissioner Marget Hamburg the FDA is rescinding its approval of the breast cancer drug Avastin. The drug was approved on an accelerated basis which required further successful tests to confirm safety. Following two additional tests the drug failed approval. The risks associated with Avastin are severe hypertension hemorrhaging heart attack or heart failure.
Commentary
In the past some accelerated approval drugs have proved to be a real problem for the public. On the one hand there certainly exists a need on the market for a drug with the purported benefits but on the other hand it still needs to be safe. The FDA did not note in their press conference any reports of incidents but the listing of side effects is severe enough that consumers should be made aware of potential problems.
Texas Defective Drug Attorney Michael Grossman
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