The FDA is sifting safety data on Johnson & Johnson's epoetin drug, which has come under a red flag thanks to a German stroke study. The study was testing high doses of Eprex (sold in the U.S. as Procrit) as a treatment for stroke patients. But it turns out that patients taking the J&J anemia drug appeared more likely to die than patients treated with placebo were. Some 14 percent of the Eprex patients died, versus 9 percent of the control group.
J&J took a proactive stance on this data: It notified the FDA of the findings last week. Now, the agency is taking a look at the German trial. It's also going to monitor several other ongoing trials that are testing the neurological effects of epoetin alfa, which also is sold by Amgen under the name Epogen.
As you know, this isn't the first time anemia drugs have come under the safety spotlight. In July, the FDA added warnings to this class of meds, aimed at limiting their use in cancer patients. Studies had shown that the drugs might cause tumors to spread and raise the risk of bleeding, too. Patients whose cancer is curable shouldn't use them, an FDA advisory panel said.