FDA Reviewing Epogen and Procrit Side Effects After Study Identifies Risk of Death

The FDA has issued an “Early Communication” about their ongoing safety review of a potential increased risk of death associated with Procrit and Epogen, which are used to treat anemia.

Epoetin alfa, which is the active pharmaceutical ingredient in both Procrit (marketed by Johnson & Johnson) and Epogen (marketed by Amgen), was recently linked to an increased risk of death in a German study where high doses of the drug were given following an ischemic stroke.

Both drugs are part of a class of medications known as erythropoiesis-stimulating agents (ESAs), which are approved to treat anemia that may develop in patients with chronic kidney failure, those with HIV who are on zidovudine and cancer patients who are on chemotherapy. Procrit and Epogen are also approved for patients undergoing major surgery (except heart surgery) to reduce the number of blood transfusions needed.

Procrit and Epogen have been widely used off-label in recent years and drug makers have faced scrutiny surrounding their promotion of the drugs, which included payments to doctors for millions of dollars each year in return for prescribing the anemia drugs.

Last week Johnson & Johnson released a statement disclosing findings from a clinical study they funded in Germany to evaluate the impact of epoetin alfa on neurological function in patients who had suffered acute ischemic strokes. The study involved 522 patients who were given either a placebo or relatively high doses of epoetin alfa intravenously for three days.

Three months after the study began, data indicated that there were substantially more deaths among users of epoetin alfa than the placebo. Approximately 16% of the stroke patients given epoetin alfa died , compared with 9% who received the placebos. About half of the deaths in both groups occurred within the seven days after starting the therapy.

On September 23, 2008, the FDA released a statement known as an “Early Communication,” indicating that they were reviewing the data from this study to evaluate the potential connection between Procit and Epogen and increased mortality. An “Early Communication” does not mean that the regulatory agency has reached a conclusion about whether there is a cause and effect relationship, but is designed to communicate the FDA’s current analysis of data concerning the drug.

The FDA anticipates they will receive additional data needed to complete their review within the next several weeks. Once conclusions and recommendations are determined, the FDA will communicate those to the public.

Doctors have been urged to follow approved uses of Epogen and Procrit in correct dosages. Patients enrolled in other clinical studies of the drugs involving unapproved uses, such as for neuroprotection purposes, will need to be carefully monitored to see if the potential benefits of the drugs outweigh the risks involved.