Since first being approved by the U.S. Food & Drug Administration (FDA) in 2004, the popular cancer drug Avastin has been linked to a large number of severe side effects which have given rise to numerous lawsuits around the country. Adverse events associated with Avastin include ovarian failure, strokes, heart attacks and more. Avastin users who suffered harmful side effects after taking the drug may be eligible to file a lawsuit against the manufacturer for their injuries.
Developed by Roche Holding AG, Avastin was approved by the FDA in 2004 for the treatment of certain varieties of lung, brain, kidney, colon and breast cancers when combined with chemotherapy. It was then granted accelerated approval for use with paclitaxel to treat breast cancer in February 2008. The medication works by restricting blood flow to tumors, thereby starving them and inhibiting their growth.
Side Effects of Avastin
Avastin side effects may include:
- severe high blood pressure
- neurological damage
- eye infections & inflammation
- streptococcus endophthalmitis
- heart attacks
- heart failure
- kidney damage
- impaired wound healing
- blood clots
- pulmonary embolism (PE)
- perforations in the nose, stomach and intestines
- jaw decay
- osteonecrosis of the jaw (ONJ)
- ovarian failure
- Worsening of coronary artery disease
- Worsening of peripheral artery disease
- Reversible Posterior Leukoencephalopathy Syndrome, a neurological disease characterized by headache, vision loss, confusion, and seizures
Avastin Ovarian Failure
In response to information stating that Avastin may affect fertility in some women, the FDA announced in October 2011 that it was requiring warning labels of the drug to be updated to include information about the risk of ‘ovarian failure.’ The administration has advised doctors to counsel women of childbearing age about the possibility that taking Avastin could potentially cause their ovaries to stop releasing eggs prematurely. Signs and symptoms of Avastin-induced ovarian failure may include:
- irregular periods (different length or bleeding or change in flow)
- hot flashes
- night sweats
- decrease in sex drive
- painful sex
- thinning and drying of vagina
The data leading up to the FDA’s decision to update Avastin’s warning labels came from a clinical trial involving 179 women with colon cancer who were being treated with chemotherapy (roughly half of whom also took Avastin). The study results found that nearly 35% of women from the Avastin group experienced ovarian failure, compared to just 2% of women receiving chemotherapy alone. Ovarian function returned in approximately 20% of the participants after discontinuing treatment with Avastin, but the long-term effects of the drug continue to remain largely uncertain.
According to new research conducted by a team at Johns Hopkins University, using Avastin in an ‘off-label’ capacity to treat wet age-related macular degeneration (AMD) was highly correlated with an increased risk of stroke and death when compared to Lucentis, a drug specifically designed to treat the condition. AMD affects more than two million Americans over the age of 50, and is the leading cause of blindness in the United States. That number is expected to double by the year 2020, as members of the ‘baby boomer’ generation continue to age.
When compared side by side, Avastin users were linked with an 11% increased risk of death and a 57% increased risk of stroke over Lucentis users. Avastin has not been approved by the FDA to treat AMD, but has been found in recent studies to be just as effective as Lucentis. The main difference between the two – as well as the likely motivation for prescribing Avastin in many situations – is that Avastin is $50 a shot while Lucentis is approximately $2,000 a shot.
Symptoms of a stroke caused by Avastin may include:
- trouble with walking
- difficulty speaking and understanding others
- paralysis or numbness on one side of the body or face
- trouble with seeing in one or both eyes
Another recent study published in the Journal of the American Medical Association (JAMA) found that Avastin may significantly increase the risk of death in some cancer patients. According to the research, the risk of death from Avastin is 2.5% when used with chemotherapy compared to a 1.7% death rate among patients being treated with chemotherapy alone.
Avastin Breast Cancer Approval Pending
In other developments, an independent advisory panel has unanimously recommended that Avastin’s approval for breast cancer be revoked. The recommendation was based on data from four clinical trials that found the drug failed to extend the lives of metastatic breast cancer patients. Avastin did show the ability to delay the onset of the condition by one to three months, but at the risk of potentially life-threatening side effects. Regardless of whether the FDA revokes Avastin’s approval for the treatment of breast cancer, the drug will remain on the market indefinitely to treat the other forms of cancer for which it is approved. Despite the controversy surrounding the drug, Avastin has enjoyed widespread success and is currently the country’s best-selling cancer medication, with annual sales topping $7 billion.