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The Food and Drug Administration has stated that it is
reviewing new data that provide further evidence of the risks of anemia drugs manufactured
by Amgen Inc and Johnson & Johnson that are administered to cancer
patients.
The main anemia drugs reviewed by the FDA are Amgen’s Aranesp,
Epogen and Johnson & Johnson’s Procrit also known as
eythropoiesis-stimulating agents or ESAs.
A study conducted by Amgen revealed that patients with
breast cancer or advanced cervical cancers who were on anemia drugs had 14 percent
higher rate of dying or had more rapid tumor growth as compared to 9.8 percent
in the placebo group. The study that revealed these data had 733 patients who
received chemotherapy and surgery for breast cancer.
“FDA is reviewing these data and may take additional action.
In the meantime, FDA recommends that health care providers review the risks and
benefits of ESAs outlined in the product label and discuss this information
with their patients," said in a statement FDA Deputy Commissioner Janet
Woodcock.
Another study of women with cervical cancer showed 66
percent of patients not being on treatment with Procrit were alive and free of
cancer growth, compared with 58 percent of those taking the drug.
Erythropoiesis-stimulating agents are drugs synthetically
engineered from a natural protein produced by kidney. This protein is
responsible for stimulating the bone marrow to manufacture more red blood
cells. The FDA approved these drugs in chronic kidney failure and in cancer
patients who have anemia because of chemotherapy.
This is not the first time when the FDA reviewed the drugs. In
March and November last year, the health agency revised boxed warnings to
reflect new data on health risks posed by these drugs. They already contain a
blackbox warning due to their cancer risk.
An FDA advisory committee will discuss the new data and
revisit the drugs’ risks and benefits in the next few months.
Both Amgen and Johnson & Johnson said they would
continue to work closely with the FDA on any additional label updates.
Moreover, they would continue to provide safety updates to health-care
providers.
Shares of Amgen Inc. rose 44 cents Thursday to $46.13 in after-hours
trading, following an earlier close at $45.69. Johnson & Johnson shares
rose 2 cents to close at $65.93.
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