Anemia drugs draw scrutiny
MINNEAPOLIS - US regulators said they're reviewing whether tests of anemia drugs from Amgen Inc. and Johnson & Johnson should continue in stroke patients after a German study linked a J&J version to increased deaths.
Johnson & Johnson informed regulatory agencies worldwide last week of the trial, which found 16 percent of patients getting its drug to protect the brain died within three months, compared with 9 percent of those on a placebo. The drugs, forms of epoetin alfa, aren't approved in the United States for treating stroke patients and most of the study participants weren't anemic.
Clinical trials in addition to the German study remain underway to determine if the drugs, which boost levels of oxygen-carrying red blood cells, can also protect the brain and help stroke patients recover more fully, the US Food and Drug Administration said yesterday about its safety review. Patients in those trials need to be closely monitored, the agency said.
More information should be available in several weeks and will be used to make recommendations on the drugs, FDA said.
J&J said Sept. 17 that stroke patients taking its drug Procrit, sold in Europe as Eprex, had a higher death rate in the German study. The trial, which started in 2003, was designed by independent investigators in Europe. J&J provided the drug and funding.
Amgen isn't supporting any studies of epoetin alfa for stroke patients and hasn't found any evidence of its widespread use for the condition, said a spokeswoman in an e-mail.
The FDA ordered changes July 30 to prescribing information for Procrit and Amgen's Aranesp after studies found safety risks in cancer patients. Procrit is identical to Epogen, Amgen's anemia medicine for kidney patients, and is sold by J&J under a licensing agreement.