Epogen, Procrit May Increase Heart Attack Damage: Study
The findings of recent research suggest that using the anemia drugs Epogen and Procrit following a heart attack is not only ineffective, but may cause further heart damage.
A study published in the current issue of the Journal of the American Medical Association (JAMA), calls into question a growing trend in the health care community to prescribe the anemia drug erythropoietin, which is marketed as Epogen and Procrit, to heart attack patients.
Use of the intravenous drug following a heart attack grew after prior research suggested that the medications could reduce heart damage. However, U.S. researchers now say that they found the opposite to be true.
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The researchers conducted a clinical trial involving 222 patients given either Epogen or Procrit or a placebo. They found no difference in efficacy when it came to the prevention of heart attacks and the treatment of heart tissue damage from previous attacks. However, five of the patients receiving the anemia drugs suffered another heart attack, developed new blockages in previous clogged arteries or died. No patients given the placebo suffered these problems.
Epogen (Epoetin alfa) and Procrit (Epoetin alfa) are prescribed to patients with kidney disease, anemia, HIV and cancer to stimulate bones to increase the production of red blood cells. They are also prescribed to patients preparing to undergo major non-heart surgery to reduce the number of transfusions such patients must receive. Amgen manufactures both drugs, though Procrit is sold and marketed by Johnson and Johnson.
In 2008, Procrit accounted for $2.46 billion in sales. Researchers estimate that by 2002, Epogen and Procrit, as well as a similar drug, Aranesp, were being prescribed to nearly half of all cancer patients.
A number of prior studies have suggested that the drugs may increase the risks of heart attack, strokes, blood clots and death, causing sales to drop in recent years.
In 2007, the FDA issued a public health advisory regarding the drugs, saying that side effects of the Anemia drugs could increase the risk of injury or death at high doses. The FDA required that the drugs add a “black box warning” alerting patients to the risk of blood clots, strokes, heart attacks and death. The black box warning is the strongest label warning the FDA can require of a medication.
In February 2010, the FDA announced that it was restricting the prescription of the anemia drugs under a risk evaluation and mitigation strategy (REMS). Doctors and hospitals that wish to prescribe the drugs now have to undergo special training to identify high risk users and negative side effects. Cancer patients using the drugs are of special concern, because some studies indicate that ESAs can stimulate tumor growth. Amgen is required to oversee hospitals and doctors using the drugs as part of a cancer treatment program to ensure they are compliant with all aspects of the REMS.
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