Researchers publishing in the August 27th issue of the online journal Clinical Drug Investigation, report that use of the cancer drug Avastin has been linked to high blood pressure and gastrointestinal bleeding.
This is not the first bad news associated with Avastin.
The drug was approved by the Food and Drug Administration (FDA) to treat breast cancer in 2011 and while it did slow tumor progression there was no change to the quality of life or eventual fatality rate. Both Health Canada and the FDA have since revoked approval of Avastin as a treatment for metastatic breast cancer because it lacked any evidence that the benefits outweighed the risks.
In the most recent findings, researchers from the Pharmacy Department of Changhai Hospital in Shanghai, China compiled a review of 15 clinical trials that included nearly 7,000 patients. The Chinese researchers found the use of Avastin was associated with a threefold risk of hypertension, a statistically significant finding. There was also a doubling of the risk of gastrointestinal hemorrhage and perforation.
In conclusion, researchers urge caution in using Avastin to treat metastatic colorectal cancer. This is significant because, although ruled out as a breast cancer treatment, Avastin is still used to treat patients with metastatic colorectal and kidney cancers and advanced nonsquamous non-small cell lung cancer.
Adverse Events Inc. monitors about 4,000 FDA-approved medications and has also uncovered similar findings about Avastin and hypertension.
Drug Safety Monitor, an online journal from Adverse Events, tapped into the FDA’s Adverse Events Reporting System (FAERS) to identify 78 cases of hypertension and 53 cases of perforation or gastrointestinal hemorrhage in patients with advanced colon cancer taking Avastin.
Avastin, made by Roche Holding AG, is an antiangiogenic meaning it blocks the formation of blood vessels that feed a tumor.
Most recently Avastin was associated with 52 serious reports of necrotizing fasciitis that occurred between November 1997 and September 2012, worldwide. There were 17 fatalities including one Canadian death, according to a news release issued by the company.
The drug company reported $6.3 billion in sales last year, according to the Wall Street Journal.