Anemia drug safety debate overblown: doctors

Debate about the safety of a group of anemia drugs widely used in cancer patients should focus on a minority of patients who got the drugs for unapproved uses, doctors said on Sunday.
Risk of death or blood clots is higher in patients who received these drugs, called epoetins, "off-label" for conditions not indicated for the treatment, said the author of a large study highlighted at the American Society of Oncology in Chicago.
The drugs are approved to treat anemia caused by chemotherapy in cancer patients and in people with kidney failure, but doctors have prescribed them more widely. Combined sales of the medicines topped $10 billion last year.
The drugs -- Amgen Inc.'s Aranesp and Epogen and Johnson & Johnson's Procrit -- pose no greater risks for 90 percent of the patients in the study, said Dr. Charles Bennett, hematologist-oncologist at Northwestern University and the study's author.
"We break no new ground," he said at the cancer meeting, where his data drew attention from doctors after a medical newsletter wrote about his analysis last week.
The so-called meta-analysis, which reviewed data from a collection of randomized trials since 2003, rekindled concerns that prompted U.S. health regulators in March to impose a "black box" warning on the drugs after studies showed an increased risk of death in cancer patients not on chemotherapy.
"What we do have is what people said all along: When the drug is used on label, there are no hidden safety signals," Bennett said in an interview.
Amgen's Roy Baynes, vice president of clinical development, said certain patients, such as those with head and neck cancer where doctors are trying to drive hemoglobin levels higher, should not use the drug off-label.
Dr. Jeffrey Crawford, professor of oncology at Duke University Medical Center, said he fears too much focus on the new analysis may cause patients needless worry. He acknowledged risks for some patients and urged more studies.
"There is an elevated risk of (blood clots) with these drugs that patients need to know about," he said.
But for the 90 percent of patients for whom the drug is approved, doctors are unlikely to change their clinical practices, he said. "I feel very confident with the current guidelines of use," Crawford said.