The FDA has just issued one of its ‘‘early communications ‘ about preliminary results from a German study that is investigating whether an anti-anemia drug can improve the neurological functioning of patients who have experienced a stroke.

Three months after the start of the study, 16 percent of the patients who had received the drug, epoetin alfa, had died compared to 9 percent of those patients who did not receive the drug, according to the agency. And so the FDA is conducting what it calls an ongoing safety review (here is the back story).

In the US, epoetin alfa is marketed as Procrit by Johnson & Johnson, and Epogen by Amgen, and in Germany, marketed as Eprex by J&J. The drug part of the class of erythropoiesis-stimulating agents (ESAs) approved for use in treating certain patients with anemia, but no ESA is approved in the US for treating stroke patients.

Most of the patients enrolled in the German study were not anemic and they were administered a relatively high daily dose of the drug (40,000 units) for three days, according to the FDA .

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 will work with the manufacturers of ESAs and other sponsors of clinical studies to evaluate the risks and benefits associated with the investigational uses of these ESA products as potential “neuroprotective agents.”