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FRIDAY, JAN 4 (News Locale) - The Food and Drug Administration in the US has announced that it was analyzing new data provided by Amgen and Johnson & Johnson, which showed new health risks from their anemia drugs called erythropoiesis-stimulating agents (ESAs).
ESAs are drugs that are bioengineered from a natural protein called erythropoietin. This protein, which is released in the kidney stimulates the bone marrow to elaborate more red blood cells and thus increases hemoglobin levels in the body.
Interestingly, soon after the FDA announcement came, Amgen shares dropped almost two percent to close at $45.69 on NASDAQ on Thursday, equivalent to a 5-year low, while Johnson & Johnson shares gained 2 cents to close at $65.93 on the New York Stock Exchange.
According to FDA Deputy Commissioner Janet Woodcock, that the regulators may come up with stringent actions against the use of such drugs following their review of the studies that established that patients with breast or advanced cervical cancer who were treated with the medicines either died sooner, or had faster tumor growth, than the patients who were not administered the drugs.
For instance, the studies state that 14 percent of the breast cancer patients using Amgen’s Aranesp died after three years, compared with just 9.8 percent of patients not taking the drug.
Another study on women suffering from cervical cancer revealed that 66 percent of patients not taking Johnson & Johnson's Procrit were alive and free of cancer growth, compared with 58 percent of those taking the drug.
According to reports, during their investigations the researchers applied Amgen's Aranesp or Johnson & Johnson's Procrit to force a patient's level of oxygen-carrying hemoglobin to 12 grams per deciliter or higher.
A statement issued by the FDA said that the researches by the scientists were reliable and matched with the earlier data related to tumor growth and death.
It said that the issue would come up for discussion with a panel comprising advisors from outside the organization at a public meeting scheduled in a few months’ time. The FDA is now also planning to re-examine the risks and benefits of ESAs for patients with chemotherapy-induced anemia.
In the meantime, the FDA has advised doctors and patients to review and discuss the risks and benefits of ESAs mentioned in the product label.
Last November, the FDA had issued new "black box" warnings for three ESAs. Aranesp and Epogen are manufactured by Amgen while Procrit is manufactured by Johnson & Johnson.
Procrit and Epogen are artificial forms of erythropoietin or epo, which is present in human kidney and boosts the production of hemoglobin. Many analysts believe that the drugs are prescribed unnecessarily as it provides a source of revenue to kidney dialysis centers and oncologists.
These drugs had been marketed as having potential to reduce feeling of fatigue in cancer patients, those suffering from HIV and chronic kidney failure. But the new labels will say that there is no evidence to back these claims.
A study published last November in the New England Journal of Medicine revealed that patients who were suffering from kidney disease and were treated with high doses of Procrit were more prone to heart attacks compared to other patients.
Over 1 million Americans use any of the three drugs, with sales of the drugs totaling more than $10 billion last year.
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