(RxWiki News) Avastin®, a cancer drug, has been shown to increase patient death from adverse events when used in conjunction with chemotherapy or biological therapy, according to new analysis of previous studies.
Senior author Dr. Shenhong Wu said this new information should change the way patients and practitioners think about the drug, adding he believes the risk-benefit ratio for the therapy has shifted in favor of risk.
Avastin® (bevacizumab) was approved by the Food and Drug Administration (FDA) in 2008 to be used in conjunction with chemotherapy for the treatment of breast cancer. The approval was based on one clinical trial in patients with metastatic HER2-negative breast cancer, which found the drug was effective at preventing cancer recurrence but not overall survival.
Three studies that were done following approval have shown no overall survival benefit and the FDA recommended revoking approval of the drug to treat breast cancer. The recommendation did not affect the drug's use in treating advanced lung, colon, kidney and brain cancers, just breast cancer.
Wu and cohorts analyzed date from 16 completed randomized controlled Avastin® trials involving more than 10,000 patients with different forms of cancer and found 2.5 percent of patients taking the drug died compared to 1.7 percent of those taking chemotherapy alone, accounting for a 46 percent increase in risk of death from adding Avastin® to chemotherapy.
The most common causes of death included hemorrhage, low white blood cell count and gastrointestinal perforations.
The authors of the study note Avastin® works well in some patients, but added predicting which patients for whom it will be effective is currently impossible.
Meanwhile the FDA has issued notification that cardiovascular risks (including heart attack) of the diabetes drug rosiglitazone (which is found in Avandia®, Avandamet® and Avandaryl®) have been added to the physician labeling and patient Medication Guide.
Dr. Joseph V. Madia cautioned that almost all drugs have side effects and the same drug does not work the same for everyone, therefore it is of utmost importance to review with your physician the risks of taking a drug along with the possible benefits.