File this under ‘going from bad to worse.’ Just a few weeks after the FDA decided to rescind the breast cancer indication for Avastin, the med sold by Roche’s Genentech unit is now linked to an increased risk of causing a fatal reaction when combined with chemotherapy, according to a study in the Journal of the American Medical Association (here is the abstract).

The side effects occurred in 2.5 percent of patients given Avastin and other meds, compared to 1.7 percent for patients treated with just chemo. The study examined 16 clinical trials of Avastin for breast, lung and other cancers involving 10,217 patients. The most common side effects leading to death were hemorrhage, gastrointestinal tract perforation and infections in patients with weakened immune systems.

And the risk of fatal side effects did not vary based on the type of tumor or the amount of Avastin administered. However, the risk was greated with Taxotere, which is sold by Sanofi-Aventis, and similar meds. For its part, Genentech noted risks are outlined in the product labeling. Avastin, you may recall, is approved in combination with chemo for treating several cancers, including colon, lung, kidneys and brain (read the background on the FDA decision on breast cancer here).

“We have to optimize use of Avastin in cancer patients so we can reduce fatal events and improve patient safety,” Shenhong Wu, the lead author and assistant professor of hematology and oncology at Stony Brook University School of Medicine in New York, tells Bloomberg News. “Physicians and patients have to be aware and recognize the risks, monitor closely and manage adverse events appropriately.”

“Is (Avastin) a boon or a bust? The jury is still out,” writes Daniel Hayes of the University of Michigan Comprehensive Cancer Center in a JAMA editorial. “Although (Avastin) has benefit, it is currently not possible to determine in whom or for how long. Thus, oncologists are forced to dilute the potential effects of (Avastin) by exposing all treated patients, and society, to enormous costs and occasional life-threatening toxic effects. These unfortunate circumstances are sad for those who pay the bills—and sadder for patients with solid tumors.” Avastin can cost about $80,000 a year.

Meanwhile, Roche released its latest earnings report today and cuts its sales forecast for Avastin by about 20 percent to roughly $7.5 billion this year, from $9.6 billion, reflecting the FDA decision. Roche, however, has experienced several setbacks over the past year or so, including a delay in a hoped-for diabetes med (look here), a decline in demand for Tamiflu and the unexpected FDA rejection of its T-DM1 biologic for advanced breast cancer (see this). Consequently, Roche is eliminating 4,800 jobs, or 6 percent of its global workforce (back story).