Procrit Attorney - Epogen (Epoetin Alpha) Lawyers

Epoetin Alpha is a synthetic form of erythropoietin, a hormone that controls red blood cell production. It is marketed under the trade names Procrit (Johnson & Johnson) and Epogen (Amgen) for the treatment of anemia, a condition in which a decreased number of red blood cells or hemoglobin in the blood make it less able to carry oxygen.

Prior to the availability of modern anemia drugs, anemic patients relied mostly on transfusions to maintain adequate red blood cell counts. But in November 2006, the New England Journal of Medicine reported on two studies that called into question the overuse of these drugs, which were selling for nearly $10 billion annually at the time. Among these drugs, Procrit and Epogen were top sellers.

While the new drugs are very effective in boosting red blood cell counts, many experts fear that doctors have become too reliant on them without sufficiently appreciating the risks of boosting hemoglobin in kidney patients. Some of these risks include:

• Heart attack
• Stroke
• High blood pressure

Then in April 2008, after an extensive safety review, the US Food and Drug Administration (FDA) announced its decision to require safety-related changes to the labeling for Procrit, Epogen, and other Erythropoiesis-Stimulating Agents (ESAs). The requirements were in line with recommendations that were made by an Oncologic Drugs Advisory Committee meeting in March 2008 under new authorities afforded by the FDA Amendments Act of 2007.

The changes include replacement of the Patient Package Insert with a Medication Guide, and modification of the wording in the Dosage and Administration, and Indications and Usage sections, and certain sections of the Boxed Warnings. Some of the modifications include statements regarding when to initiate and discontinue ESA dosing, and a warning that ESAs should not be used in patients undergoing myelosuppressive therapy with a favorable prognosis.

Although these changes should be lauded, they provide no solace to patients who've been injured by ESAs, or to their families. If you or a loved one has been injured by Procrit, Epogen, or any other ESA, you may be entitled to compensation. By law, however, you may have a limited time to act. To know your rights, it is advisable to consult with a qualified pharmaceutical injury attorney.