Before a new drug can be approved by the FDA and enter the market, it must comply with certain regulations to ensure its safety and effectiveness. Unfortunately, there are a number of deceptive practices which can be employed by the manufacturing company in order to expedite the FDA approval process. In some cases, the pharmaceutical company may withhold the more serious side effects associated with the medication in an attempt to avoid rejection by the FDA. Sometimes, the FDA will immediately approve a new drug based upon preliminary information with the condition that further clinical trials will be performed in the meantime. These misleading practices make potentially dangerous drugs available to consumers without full and accurate knowledge of the risks to which they may be subjecting themselves. These risks may result in the development of life-threatening and potentially fatal side effects by consumers who were inadequately informed by the companies responsible for the safety of their drugs. Unfortunately, consumers are vulnerable to the misleading practices of drug manufacturing companies on a daily basis. The only way to effectively stand up to the deception of big drug companies is to contact a qualified attorney and file a defective drug lawsuit.
Recent studies have revealed the harmful nature of Avastin, linking the drug to life-altering complications which may even result in death. In response to these discoveries, the FDA recently announced that the agency is recommending removing the breast cancer indication from the Avastin label because the drug has not been shown to be effective or safe for that use.
In order for a medication to be approved by the FDA and remain on the market, the benefits of the drug must outweigh the drug’s potential for harm. After reviewing the results of several clinical studies involving women with breast cancer who took Avastin, the FDA determined that the drug does not prolong overall survival in breast cancer patients or provide an adequate benefit in slowing the progression of the disease to outweigh the significant risk to Avastin consumers. In other words, not only are individuals with breast cancer who take Avastin unlikely to live longer, but they are also at risk for developing serious side effects linked to the drug. Based upon all data collected, the FDA has ruled that the risks of Avastin significantly outweigh the benefits of its use.
Avastin, a drug which has accumulated more than $5.5 billion in global sales, has been shown to increase the risk of potentially fatal side effects by nearly 50% when used in combination with chemotherapy, as compared with chemotherapy treatment alone. In fact, according to the Journal of the American Medical Association, about 2.5% of cancer patients who combine Avastin with chemotherapy treatment die from the treatment rather than from their disease. In another analysis involving 10,000 patients being treated for tumors, 5,589 of them were treated with Avastin and chemotherapy. Of the Avastin group, 148 died, compared to only 72 patients being treated with chemotherapy alone who died. The most prevalent danger of Avastin is that it is virtually impossible to determine which patients will benefit from the drug and which patients will suffer the consequences.
There are a number of severe adverse side effects linked to the use of Avastin, including:
According to research, severe and sometimes fatal instances of gastrointestinal perforation occurred more often in people who took Avastin, and was seen in 0.3% to 2.4% of those people. Most cases of GI perforation occurred within only fifty days of beginning Avastin therapy and included symptoms like abdominal pain, nausea, vomiting, fever and constipation. Severe and sometimes fatal stroke or heart problems were experienced by 2.4% of people who took Avastin and included symptoms like blood clots, stroke, heart attack and chest pain.
Despite the substantial potential for harm associated with this drug, Avastin has not yet been removed from the market and the FDA’s decision will not affect the drug’s approval for treating brain, kidney, lung and colon cancers. This means that Avastin will remain on the market, available to consumers who may not be aware of the drug’s potential for harm. Victims of serious injury or death related to the use of Avastin are not at fault. If you or a loved one has suffered from an Avastin injury, contact an Avastin attorney to discuss the benefits of filing a defective drug lawsuit against the drug’s manufacturing company. A number of Avastin injury cases may be investigated across the country and if you have experienced an adverse side effects of Avastin, you may be entitled to compensation for your injuries. Pharmaceutical companies should be held accountable for the dangers associated with their medications. Avastin lawyers are experienced in defective drug litigation and have the knowledge and skills necessary to stand up for your rights and help injury victims develop a successful case against Avastin’s manufacturer.