Avastin was originally approved by the FDA in 2008 to treat individuals suffering from breast cancer, and is designed to function by stopping the growth of blood vessels that feed tumors. The drug was fast-tracked through the FDA’s accelerated approval program in order to allow cancer patients earlier access to the drug under the assumption that Avastin could safely and effectively treat their condition. Because the drug was approved according to preliminary data only, there was a significant risk involved for patients who took the drug before testing was complete. Avastin was required to undergo further clinical trials, but in the meantime, the drug was available to millions of people suffering from cancer. Once testing was complete and numerous studies were performed, the harmful nature of Avastin was brought to light and the FDA announced that it was revoking its approval of the use of Avastin for breast cancer treatment. This FDA decision was due in large part to research associating Avastin with potentially life-threatening conditions like stroke, heart attack, heart failure and GI tract perforations.
Gastrointestinal perforations are a rare but extremely dangerous complication that can take place anywhere in the GI tract, including the stomach, small bowel and colon. According to the National Institutes of Health, gastrointestinal perforations result in leakage of intestinal contents into the abdominal cavity, causing an inflammation known as peritonitis. Common symptoms of GI tract perforation include severe abdominal pain, fever, chills, nausea and vomiting. Individuals suffering from GI tract perforation typically take antibiotics and may require surgery, which poses a considerable risk for cancer patients already weakened by chemotherapy. GI tract perforations are a severe condition which can result in fatality.
The dangers associated with Avastin have been evident for quite some time. In 2009, the FDA required Genentech to include a black box warning on Avastin’s label, warning consumers about the potential for the medication to cause GI tract perforations. The FDA also encouraged patients who already had a GI perforation to permanently discontinue the use of Avastin. Avastin is believed to either damage the structure and function of gastrointestinal vasculature, which can result in perforation of the normal bowel, or prevent the healing of gastrointestinal ulcers which could develop into perforations.
According to research, Avastin significantly increases the risk of potentially life-threatening GI tract perforations, compared to individuals who were treated with a control medication. According to a study published in The Lancet Oncology, a meta-analysis of seventeen randomized trials involving 12,294 patients with a variety of solid tumors, patients treated with Avastin had twice the risk of developing this condition as patients treated with the control mediation. According to this study, lower doses of Avastin increased an individual’s risk of developing GI perforations by 61 percent while at a higher dose, the risk increased by 167 percent. Furthermore, researchers discovered a mortality rate of 21.7 percent in patients who developed GI tract perforations. This is one of the first studies to discover a direct connection between Avastin and GI tract perforation.
FDA approval for cancer treatment should be contingent upon evidence that the drug extends or improves the quality of patients’ lives, while effectively and safely treating the condition. According to recent research, Avastin does neither. In fact, Avastin taken in combination with other cancer treatments, such as chemotherapy, is believed to increase a cancer patient’s treatment-related risk of death by 1.5 times, compared to those taking the same cancer treatment without Avastin. Among those taking Avastin, 23.5 percent of deaths were caused by hemorrhages, 12.2 percent were caused by a blood disorder called neutropenia, and 7.1 percent of deaths were caused by GI tract perforation.
When it comes to cancer treatments, the risks involved are commonly significantly higher than that of other medications. However, the possible benefits of the drug, including effectively and safely treating the condition, typically outweigh the risks. Unfortunately, for breast cancer patients, Avastin neither prolongs survival rate nor offers a safe alternative to other cancer treatments. Because of the harmful side effects associated with Avastin, the FDA has withdrawn its approval for using the drug to treat breast cancer patients. However, despite Avastin’s potential to cause significant harm, the drug is still used to treat kidney, colon, lung and brain cancers.
Victims of serious injury associated with Avastin use are not at fault and may be entitled to reimbursement for their injuries. The only way to protect your rights is to contact an Avastin attorney to discuss the benefits of filing a defective drug lawsuit. If you or a loved one has suffered from GI tract perforations, an Avastin lawyer may be able to help you collect the compensation you deserve. Avastin attorneys are extremely experienced in defective drug litigation and have the knowledge and skills necessary to help Avastin victims develop a successful case against the drug’s manufacturing company.