A new study has found that using the anemia medications Epogen and Procrit may cause extensive heart damage when taken after a heart attack. The compelling research has called the use of such drugs into question, as the risks seem to heavily outweigh any possible benefit. Last year, the FDA announced that it was restricting the prescription of both Epogen and Procrit under a risk evaluation and mitigation strategy (REMS) to identify high risk users and negative side effects.
What’s the problem?
May 26, 2011 – According to a study published in the current issue of the Journal of the American Medical Association (JAMA), using the anemia drugs Epogen and Procrit (epoetin alfa) following a heart attack serves little purpose and could actually increase the risk of permanent heart damage. The new research challenges a previously held assumption by the medical community that such drugs are effective at reducing heart damage.
The study involved 222 patients given either Epogen or Procrit or a placebo, and found that there was no difference in efficacy when it came to the prevention of heart attacks or the treatment of heart tissue damage from previous attacks. However, five participants who took the drugs experienced new heart attacks, blocked arteries, or died. None of the patients given placebos experienced any adverse side effects. The new JAMA study seems to support prior research suggesting that Epogen and Procrit may increase the risk of heart attacks, strokes, blood clots and death.
FDA Warning on Epoetin Alpha
An FDA Early Communication about epoetin alfa was prompted by preliminary findings from a clinical trial in Germany examining the use of epoetin alfa to treat acute ischemic stroke. 16 percent of the group of patients who received epoetin alfa died within ninety days after the start of the trial compared with nine percent of those who received placebo.
“Over a period of ninety days after the start of the trial, there were more deaths in the group of patients who received epoetin alfa compared to patients who received the placebo (16% versus 9%). Roughly half of all deaths in both groups occurred within the first seven days after starting the drug, with death from intracranial hemorrhage (bleeding within the brain) occurring among approximately 4% of patients who received epoetin alfa compared to 1% of patients in the placebo group.”
Manufactured by Amgen, Epogen and Procrit are FDA approved medications prescribed to treat kidney disease, anemia, HIV and cancer. The drugs are designed to stimulate bones to increase the production of red blood cells. Epoetin alfa is also commonly used in individuals preparing to undergo major non-heart surgery to reduce the number of transfusions such patients must receive.
By 2002, Epogen and Procrit were reportedly prescribed to nearly half of all cancer patients. In 2008, Procrit amassed a staggering $2.46 billion in sales. After reports of serious side effects and adverse events associated with the medications, the FDA in 2007 required the drugs to include a ‘black box’ warning on their packaging alerting consumers to the risk of heart attacks, strokes, blood clots and death. A black box warning is the strictest label warning a medication can carry allowed by law.