U.S. FDA probing deaths in anemia drug study

U.S. health officials said on Friday they were reviewing a higher rate of deaths among patients treated with a Johnson & Johnson anemia drug in a German study of stroke patients.

Sixteen percent of patients who were treated with the drug Eprex had died three months after the study began, compared with 9 percent who got a placebo, the Food and Drug Administration said in a statement.

The study was testing if Eprex could improve brain function in stroke patients, an unapproved use of the drug. The 522 patients were given relatively high doses of Eprex for three days or a placebo. Most were not anemic, the FDA said.

Eprex is known generically as epoetin alfa. J&J also sells epoetin alfa under the name Procrit. Amgen Inc sells a version under the name Epogen.

The blockbuster drugs are part of a class called erythropoiesis-stimulating agents (ESAs), which are approved for treating patients with kidney disease and cancer.

The safety of ESAs came under scrutiny in recent years after other studies found tumor growth or shorter survival for some patients given high doses. The FDA ordered strong new warnings on the medicines in July.

The agency said on Friday it was aware of other trials testing the potential neurological effects of epoetin alfa.

The higher death rate in the German study “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 said.

J&J reported last week that early data showed Eprex patients in the German study died more frequently than placebo patients, and said it was doing additional analyses to better understand the findings. The company alerted the FDA to the findings, J&J spokesman Mark Wolfe said on Friday.

The study was initiated by the researcher, Wolfe said. J&J provided funding and supplies of the drug but was not involved in the trial’s design or conduct, he said.

Roughly half of the deaths in both groups occurred within seven days after starting treatment, the FDA said. Death from bleeding in the brain was reported for about 4 percent of Eprex patients compared with 1 percent in the placebo group.

The FDA said it expected to receive more data within the next several weeks and would announce its conclusions when its review was complete.

Wolfe said J&J is not currently doing any research of epoetin alfa for stroke treatment but has supported independent researchers testing potential neurological benefits.

Amgen is not supporting or sponsoring any studies of ESAs for brain protection and has not found evidence of widespread use for that purpose, company spokeswoman Emma Hurley said.

By Lisa Richwine
WASHINGTON (Reuters)