Preliminary data from a study funded by Johnson & Johnson’s Ortho Biotech unit found that individuals who were given Procrit (which is also marketed as Epogen) following an ischemic stroke had a greater incidence of death than those who received a placebo.
The study evaluated the side effects of Epoetin alfa, which is a drug marketed in the United States as Procrit by Johnson & Johnson’s Ortho Biotech and Epogen by Amgen. Outside the U.S. it is sold as Exprex or Erypo. Although the drug is not approved for treatment following an ischemic stroke, the data raises serious concerns about the potential side effects of Procrit, Epogen and other drugs containing Epoetin alfa.
Epogen and Procrit are anemia drugs that the FDA has approved for treatment of patients with chronic kidney failure who are undergoing dialysis, cancer patients under going chemotherapy, HIV patients whose anemia is caused by AZT (zidovudine) and for patients scheduled for major non-heart surgery, to reduce the number of transfusions. However, the drugs have been widely prescribed off-label for a number of uses.
Johnson & Johnson released a statement yesterday disclosing the preliminary findings from an experimental study designed to evaluate the effects of Epoetin alfa in patients who suffered an acute ischemic stroke. Among patients who were given the drug within six hours of suffering from symptoms of stroke, data revealed that there was a higher rate of death than among those who had taken a placebo.
The U.S. FDA and European regulatory authorities have been notified about the findings, and Johnson & Johnson indicated in their statement that the drugs should only be used strictly in accordance with their approved indications and dosing recommendations.
Procrit and Epogen are members of a class of medications known as erythropoiesis stimulating agents (ESAs), which also includes Amgen’s Aranesp (darbepoetin alfa) . A number of concerns about potential side effects of these widely used drugs have emerged over the past two years.
In March 2007, the FDA added a “black box” warning to Epogen, Procrit and Aranesp about potential side effects which could increase the risk of blood clots, strokes, heart attacks or death when given at high doses. They have also been linked to an increased rate of tumor growth when given to patients with certain types of cancers.
The manufacturers of these drugs have also faced intense scrutiny surrounding the promotion of these drugs, which has led to wide overuse for unapproved conditions, such as symptoms of anemia. The drug makers have been accused of paying doctors hundreds of millions of dollars each year in return for prescribing the anemia drugs to their patients.