Results From Large Long-Term Study Show Association Between These Erythropoiesis-Stimulating Agents And Venous Thromboembolism

(Posted by Tom Lamb at DrugInjuryWatch.com)

In late October 2009 we learned that the results from the Trial to Reduce Cardiovascular Events with Aransep Treatment (TREAT) indicated that the anemia drug Aranesp might cause an increased risk for stroke in patients with diabetes and chronic kidney disease.

Just a couple of weeks later we have been presented with a possible explanation as to why this might be so.

From a November 10, 2009 article by HealthDay reporter Steven Reinberg, "Anemia Drugs May Cause Deadly Blood Clots", we get this new information about erythropoiesis-stimulating agents (ESAs) such as Procrit (epoetin alfa) and Aranesp (darbepoetin alfa):

"These drugs hit the market in the mid-1990s, and by 2002, 50 percent of patients on chemotherapy were receiving them," said lead researcher Dr. Dawn Hershman, co-director of the breast program at the Herbert Irving Comprehensive Cancer Center at New York-Presbyterian Hospital/Columbia University Medical Center in New York City.

Initial testing of these drugs was done on only 12 weeks of use, she noted. "Right from the beginning, there was concern that these drugs would cause some side effects, but the initial studies did not find any risk of thrombosis."

Her longer study was more informative. "We confirmed that these agents can increase the risk of thrombosis by twofold," Hershman added…. [emphasis added]

Hershman thinks the findings raise questions about the drug's approval process and whether adequate post-marketing research was undertaken to ensure their long-term safety.

These drugs do have a place, she said. "But we have to figure out what the best indication is and use every agent with caution. We should think about the drugs that we give."

The underlying study, "Patterns of Use and Risks Associated With Erythropoiesis-Stimulating Agents Among Medicare Patients With Cancer", was published in the November 10, 2009 online edition of the Journal of the National Cancer Institute in advance of its print publication in the December 2 edition of this medical journal.

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