FDA Told Anemia Drugs Pose Safety Risk

A panel of outside experts tells the Food and Drug Administration that three drugs used to treat anemia in patients with kidney failure, HIV or cancer pose health risks. The experts recommend stronger warning labels.

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The Food and Drug Administration is taking another look at a popular class of drugs that are commonly prescribed for patients with cancer or HIV or kidney failure. Recent reports suggest those drugs leave some patients worse off, even sometimes causing death. The FDA asked a panel of outside experts for help. And yesterday, those experts told the agency there really is something to worry about.

NPR health reporter Joanne Silberner is covering this story.

And Joanne, what are these drugs?

JOANNE SILBERNER: Well, there is three: Aranesp, Epogen and Procrit. Some people may remember Procrit because it was heavily advertised. And what they do - when you have chemotherapy or kidney dialysis or HIV, that can knock down your red blood cells, make you anemic. These products bring it back up. And they carry more oxygen and you feel better.

INSKEEP: Which should be good, but what did the advisory committee say?

SILBERNER: They want stronger warning labels, definitely stronger warning labels, because they're concerned doctors are overusing these drugs a bit. They want more research. And this wasn't voted on, but I think they want the drugs less heavily promoted.

INSKEEP: When we talk about causing some patients to be worse off, is this a matter of percentages, maybe 100 people are healthy but there maybe 40 people out there or 10 people or two people out the who are actually harmed. Is that how it works?

SILBERNER: Well, it's hard to tell how many. Because the problem here is that most of the studies have to do with doctors who prescribe the drugs at a higher value than the FDA would like to see. The FDA would like to see them prescribed just to the point where you're just getting out of anemia. But doctors are boosting blood levels up to normal levels, and that's where the problems are being seen. Now they're going back and asking for more data back at these lower levels that are the ones that are supposed to be used.

INSKEEP: What exactly are the problems? What are the side effects that people have?

SILBERNER: Well, they're pretty significant: heart attacks, death, stroke. With some of the cancers they're starting to think that maybe, especially in the higher doses, these drugs actually promote the progression of cancer. One advisory committee member said he asked the company, said this is a miracle road drug for cancer. The answer is nobody knows.

INSKEEP: Well, now, let me ask about these warnings. You mentioned that this advisory committee wants warnings. Didn't the FDA already issue some warnings about these very drugs?

SILBERNER: Yeah. If you look at the label, it's actually pretty sobering. They do warn about them, and they remind doctors please do not use these drugs to bring the red blood cell levels back to, you know, high or normal levels. Just bring them back to the point where you don't need a transfusion anymore.

INSKEEP: So, why would anybody want to take these given that they're now going to be warnings on top of warnings on top of warnings?

SILBERNER: Good question. It's really this issue of anemia. The only treatment before the drugs came along for anemia is blood transfusion. So now the American blood supply is pretty - is chronically low. It can be hard to find blood to transfuse. You know, it's a big process. You have to get it dripped in. There is less of a risk now, though, of infections, which is what was happening. In the beginning, when these drugs were approved, there was no question that transfusions were pretty risky.

INSKEEP: So what does this mean for a drug company when news like this comes out?

SILBERNER: Well, their stocks went down yesterday pretty precipitously, I think nine percent in one of the companies that make it. These drugs are huge moneymakers. There were $10 billion in sales last year. And, you know, it may means something to doctors, too. Doctors make money prescribing these drugs, especially oncologists. One of the advisory committee members yesterday said that they make as mush as $1,000 for administering it.

INSKEEP: Joanne, thanks very much.

SILBERNER: Thank you.

INSKEEP: That's NPR's Joanne Silberner.

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