Widely used anemia drugs Procrit, Epogen and Aranesp can increase the risk of life-threatening side effects and death in certain patients, the federal government said in ordering a “black box” warning for the drugs in March 2007.
The U.S. Food and Drug Administration cited reports of studies showing a higher incidence of side effects and a “greater number of deaths” in patients treated with the agents, which are used to stimulate the body’s production of red blood cells.
It noted particular concern for patients most likely to aggressively use Procrit, Epogen and Aranesp, such as those with kidney disease undergoing dialysis, for which an increased risk of blood clots, strokes, heart attacks and death was noted. Also, certain cancer patients experienced accelerated tumor growth when they used the drugs.
If you or someone you love suffered severe side effects or death as a possible result of using one of these anemia drugs, you may want to contact a Procrit attorney or an Epogen attorney or an Aranesp attorney.
The FDA noted that certain cancer patients on chemotherapy suffered more rapid tumor growth if they used higher-than-recommended doses of the anemia drugs. In particular, it cited patients with head and neck cancer taking radiation therapy and patients with metastatic breast cancer receiving chemotherapy.
But it added that even when used in recommended doses, the drugs increased the risk of death among cancer patients not taking chemotherapy. And it also reported a higher incidence of potentially dangerous blood clots when Procrit, Epogen or Aranesp were used in patients scheduled for major surgery (to produce more red blood cells and thus hopefully reduce the need for transfusions).
Further, the FDA said there had never been any hard evidence that the drugs could – as advertised to consumers – increase energy levels or reduce fatigue in patients undergoing therapy for cancer.
The drugs are manufactured and marketed by Amgen Inc. and a Johnson & Johnson subsidiary, Ortho Biotech Products, L.P. and are known collectively as erythropoieses-stimulating agents, or ESAs. The three drugs were reported to have had total U.S. sales of $10 billion in 2006.
Kline & Specter, PC, with more than 40 experienced attorneys, several of whom are also highly regarded doctors, is one of the nation's leading law firms with the ability to litigate pharmaceutical drug lawsuits. Contact a Procrit lawyer or an Epogen lawyer or an Aranesp lawyer today.