Article: FDA Announces Ongoing Safety Review of Procrit / Epogen


Less than two years after the New England Journal of Medicine reported on two studies that called into question the overuse Johnson and Johnson's Procrit and Amgen's Epogen, the Federal Food and Drug Administration (FDA) released an unrelated Early Communication about an Ongoing Safety Review concerning these drugs. Epoetin alpha (the generic name of Procrit and Epogen) is in the class of drugs known as erythropoiesis stimulating agents (ESAs) that are approved by the FDA to treat certain patients with anemia.

The FDA release 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.

In fact, about half of the deaths in both groups occurred within seven days after starting the drug, and about four times the number of patients in the experimental group died of bleeding within the brain (intracranial hemorrhage) than that of those in the control group.

An FDA official remarked that "the finding of increased mortality of patients receiving epoetin alfa suggests that, until additional data and analyses are available, it is important to evaluate whether the potential benefits for patients enrolled in other neuroprotection studies of the drug outweigh the risks."

The FDA has committed itself to working with the manufacturers of ESAs to better evaluate these risks and benefits. Meanwhile, the agency urges patients and healthcare professionals to report adverse effects associated with the use of ESAs to their MedWatch Adverse Event Reporting program via telephone (1-800-332-1088), fax (1-800-FDA-0178), mail (send FDA FORM 3500 to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787), or online.

You may also wish to contact a qualified pharmaceutical injury attorney for an evaluation of your case. You may be entitled to compensation.

See also:
Procrit / Epogen Lawyers