| Consumer Alert! Avastin FDA Warns That Cancer Medication Could Cause Ovary Failure; Jaw Death and Bleeding Also Indicated
Consumers take note -- the U.S. Food and Drug Administration has issued a new warning about the cancer drug Avastin (bevacizumab) and the effect it can have on ovary function.
On Sept. 30, 2011, the FDA added new language to Avastin’s label that warns women of the increased potential for ovarian failure. At the same time, the FDA also identified osteonecrosis --- or bone death of the jaw and bleeding in venous thrombosis patients -- as additional risks associated with Avastin.
If you believe that you have suffered ovarian failure, osteonecrosis of the jaw, excessive bleeding or other severe side effects due to Avastin, call now to talk with the defective drugs attorneys at Janet, Jenner & Suggs, LLC. We have nationwide experience with dangerous product lawsuits, and we are committed to helping victims of unsafe drugs.
Call now: 1-888-4-MED-LAW or contact our drug injury lawyers online. The call and the consultation are free.
New Warning About Avastin
The warning about Avastin’s effect on ovary production came in response to a study involving 179 women who were receiving chemotherapy for colon cancer. Out of the study participants who took Avastin as part of their regimen, 34 percent developed amenorrhea, a condition where menstruation stops for at least three months. Only 2 percent of the women in the study who had not used Avastin developed the condition.
Nearly one-quarter of the women who experienced ovarian failure began menstruating again after they stopped taking Avastin.
The study was inconclusive regarding Avastin’s long-term effects on women’s fertility.
Background on Avastin
The best-selling cancer drug in the world and one of the most expensive medications, Avastin (bevacizumab) was developed, made and marketed by Genentech, Inc., a subsidiary of Roche AG, a Swiss pharmaceutical company. The FDA first approved Avastin in 2004.
Avastin works by halting the growth of new blood vessels, particularly those that supply blood to cancerous tumors. It has been prescribed as a part of chemotherapy regimens for patients with colon cancer, kidney cancer, lung cancer, brain cancer and other types of cancer. The FDA approved Avastin for the treatment of metastatic breast cancer in 2008, even though an advisory panel opposed that approval because studies showed the drug slowed tumor growth without prolonging survival.
In December 2010, an FDA advisory panel recommended removing Avastin’s indication for the treatment of breast cancer. The FDA panel’s decision was based on the results of four clinical studies that showed that Avastin did not increase overall survival and did not provide sufficient benefits to breast cancer patients to overcome the risks posed by the drug. The FDA has not made a final decision on whether to follow the panel’s recommendation. The FDA panel upheld its recommendation in June 2011 after an appeal from the pharmaceutical company, although the FDA had not taken action on it by October 2011.
If the FDA follows the panel’s recommendation to remove Avastin’s breast cancer indication, it would merely prevent Genentech from marketing Avastin for the treatment of breast cancer. Doctors would still be able to prescribe the medication to breast cancer patients, although some insurance companies will not pay for such “off-label” uses.
Avastin Sales
Avastin is Roche’s best-selling medication, and the company stands to lose about $1 billion if the FDA acts on the panel’s recommendation to remove the breast cancer indication, according to an Associated Press article. The pharmaceutical company grossed about $6.5 billion on Avastin during 2010, according to the AP.
Starting in October 2011, Blue Shield of California — one of the nation’s largest health insurance companies — will no longer cover new Avastin prescriptions for breast cancer patients. According to an Associated Press article, the insurance company based its decision on the FDA’s findings that Avastin did not provide enough benefits to breast cancer patients to justify its side effects. Several smaller health insurers already decline coverage of new Avastin prescriptions for breast cancer patients, and more are expected to follow suit.
New Avastin Warning
The FDA’s latest action on Avastin came on Sept. 30, 2011, when it added a warning to the drug’s label indicating that Avastin puts women at increased risk of ovarian failure. The FDA recommended that doctors advise female patients that Avastin could cause their ovaries to stop releasing eggs. The warning was not connected to the issue over whether Avastin should lose its approval for the treatment of breast cancer.
The new label also states that the FDA has received reports of bone death in the jaw that are apparently related to Avastin use, although the FDA said it is not clear whether Avastin causes osteonecrosis. The updated label also indicates that a study has shown increased bleeding associated with Avastin in patients who are receiving anti-coagulation treatments after experiencing a clotting event.
Side Effects of Avastin
In addition to ovarian failure, osteonecrosis of the jaw and bleeding, Avastin has also been associated with the following serious side effects:
- Perforations or holes in body parts, including the stomach, nose and intestines;
- Severely high blood pressure;
- Heart attack;
- Heart failure; and
- Seizures.
Get Help From Our Avastin Lawyers Now
Immediately contact your doctor or health care provider if you suffer any serious side effects related to Avastin. If it is an emergency, call 911. You should also contact your doctor or other health care professional about changing to another medication.
Then call the MEDLAW Legal Team of Janet, Jenner & Suggs, LLC. The drug injury attorneys at Janet, Jenner & Suggs have received national recognition for our efforts to help people who have suffered because of dangerous prescription drugs. We believe that pharmaceutical companies should be held responsible for the consequences of their products.
We take care of your drug injury case directly, unlike many law firms that advertise aggressively on the Internet and then hand the cases off to other attorneys. The legal team at Janet, Jenner & Suggs is made up of litigators who have the experience and resources necessary to give you the representation you deserve.
If you suspect that you or a loved one has suffered serious side effects related to Avastin (bevacizumab), contact our drug injury lawyers now. You can reach us at (877) 425-3448, or use our online contact form.
We have a physician-attorney, a nurse-attorney and more than 30 staff members on our in-house medical legal team. As a leading pharmaceutical liability law firms, our personal injury lawyers represent consumers nationwide who have been harmed by the medications that were supposed to help them.
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