Loading ...Users of Avastin may need to determine whether they have legal claims against the drug’s manufacturer. On Thursday, the FDA withdrew its approval of Avastin, a breast cancer drug that was generating over a billion dollars for its manufacturer Genentech. The government’s action came after extensive testing failed to prove the drug was any more effective than standard chemotherapy. Since Avastin was not providing the benefits that the cancer patients were seeking, the FDA found that the severe health risks that the drug posed were unacceptable. These side effects are known to include: severe high blood pressure, heart attacks, heart failure, massive bleeding, perforations in the stomach, and perforations in the intestines.
In announcing the FDA’s action, Commissioner Margaret Hamburg said, “I did not come to this decision lightly.” She added, “Despite the hopes of investigators, patients, industry and even the FDA itself, the results of rigorous testing can be disappointing.” Those tests had been designed to prove whether Avastin was allowing any definitive group of breast cancer patients to live longer or to enjoy a higher quality of life after their breast cancer had metastasized. The tests could not identify any specific subset of breast cancer patients who consistently showed improvement with the Avastin infusions, although scientists had hoped to identify certain types of tumors containing unique genetic markers, where the drug might show demonstrable benefits. Clearly, the FDA did not believe those tests were successful.
In the wake of this decision, many users of the drug are evaluating their legal options. For those who took Avastin, and later suffered heart attacks, heart failure, perforations of the stomach or intestines, or the onset of high blood pressure, their may be viable legal claims. Although many of these side effects were known (at least to some doctors and specialist) prior to Thursday’s action by the FDA, Genentech’s
