FDA: Preliminary Safety Findings on Epoetin Alfa to Treat Acute Ischaemic Stroke

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Title: FDA: Preliminary Safety Findings on Epoetin Alfa to Treat Acute Ischaemic Stroke
URL: http://www.pslgroup.com/dg/22DA26.htm
Doctor's Guide
September 26, 2008

ROCKVILLE, Md -- September 26, 2008 -- The US Food and Drug Administration (FDA) has been made aware of preliminary safety findings from a clinical trial conducted in Germany investigating the use of epoetin alfa (Eprex) to treat acute ischaemic stroke.

Over a period of 90 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% vs 9%).

Roughly half of all deaths in both groups occurred within the first 7 days after starting the drug, with death from intracranial haemorrhage occurring among approximately 4% of patients who received epoetin alfa compared with 1% of patients in the placebo group.

Treatment of anaemia was not a goal of the trial and most patients were not anaemic. Additional trial baseline and outcome data are currently being analysed.

The trial was a double-blind, placebo-controlled, multicentre investigation in 522 adult patients with an MRI-confirmed ischaemic stroke in the area of the middle cerebral artery.

Patients were randomised to either receive treatment with a placebo or epoetin alfa administered as an intravenous dose of 40,000 units daily for 3 days. Recombinant tissue plasminogen activator (r-tPA) was also used when clinically indicated.

The goal of the trial was to determine whether a relatively high dose of epoetin alfa (40,000 units daily) administered for 3 days would improve the ability of patients to care for themselves after their strokes.

The clinical trial utilised doses of epoetin alfa that were considerably higher than the doses recommended for the treatment of anaemia as described in the FDA-approved labelling for the product.

The FDA is aware of other clinical trials using epoetin alfa for potential neuroprotective effects. The finding of increased mortality in patients receiving epoetin alfa in the German trial suggests the need to closely monitor patients enrolled in other ongoing trials for adverse outcomes and to evaluate whether the potential benefits for enrolled patients outweigh the risks in these trials.

The FDA anticipates the receipt of additional data within the next several weeks. As soon as the review of these data is complete, the FDA will communicate their conclusions and recommendations to the public.

The FDA urges both healthcare professionals and patients to report side effects from the use of erythropoiesis stimulating agents to the FDA's MedWatch Adverse Event Reporting program:

· On-line at

www.fda.gov/medwatch/report.htm

· By returning the postage-paid FDA form 3500 available in PDF format at

www.fda.gov/medwatch/getforms.htm

to 5600 Fishers Lane, Rockville, MD 20852-9787

· Faxing the form to 1-800-FDA-0178

· By phone at 1-800-332-1088

SOURCE: US Food and Drug Administration

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