FDA issues warnings about three top selling drugs

March 12, 2007

I took all of these during chemo. :-(Cyndi

FDA issues strong warning on three top-selling drugs

By Liz Szabo, USA TODAY

The Food and Drug Administration issued its strongest possible warning Friday for three top-selling drugs commonly used to treat anemia in cancer patients and those undergoing kidney dialysis.

In a public health advisory, the FDA warned that high doses of Procrit, Aranesp and Epogen may increase the risk of blood clots, strokes, heart attacks and deaths in patients with chronic kidney failure.

Recent studies suggest that the drugs, which are commonly prescribed to cancer patients receiving chemotherapy, may actually make tumors grow faster and increase the risk of death, if given in high doses, says the FDA's Richard Pazdur, who announced the new "black box" warning.

The drugs are synthetic versions of a natural protein called erythropoietin, which raises the number of oxygen-carrying red blood cells. Without erythropoietin, patients may become anemic, making them feel weak and exhausted.

In chemo patients, doctors often prescribe the drugs to raise red blood counts and avoid riskier treatments, such as transfusions, Pazdur says.

Scientists don't know why they may fuel tumor growth, says the FDA's Patricia Keegan. It's possible, however, that tumors contain receptors for erythropoeitin, which make spur their growth, Keegan says. The drugs also may affect tumor blood supplies.

To reduce these risks, the new label urges doctors to use the lowest possible doses, Pazdur says.

Studies have raised concerns about the drugs for several years.

The FDA has revised their labels three times since 1997. An FDA advisory committee discussed the drugs' safety in 2004 and plans to review the issue again at a meeting in May, when it may revise their labels further.

Doctors will be more careful to keep their doses low, however, and to use the drug only as approved, says Mark Heaney, a hematologist at New York's Memorial Sloan-Kettering Cancer Center.

"For a long time, we considered these drugs almost like giving water," Heaney says.

Procrit also has been touted as a way to make patients feel stronger. An ad on Procrit's website says, "Find your energy during chemo."

Pazdur notes that the drugs aren't approved to treat the symptoms of anemia, such as fatigue, in cancer patients. The FDA is reviewing company claims about the drugs' effects on quality of life, Pazdur says.

California-based Amgen Inc. manufactures all three drugs, although Ortho Biotech LP, a subsidiary of Johnson & Johnson, markets and distributes Procrit.

Ortho Biotech spokeswoman Stephanie Fagan says the company is evaluating its marketing claims "to make sure they are consistent with the new label."

Both Fagan and Amgen's chief executive officer, Kevin Sharer, say their companies are committed to patient safety. Sharer said the two companies are sending letters to doctors to educate them about safety risks.

The drugs are some of the top 10 best-selling drugs. Aranesp had sales of $3.9 billion last year. Epogen's sales were $3.2 billion, according to IMS Health, which tracks the pharmaceutical industry.

Hospitals spend more on epoetin alpha, the ingredient in Procrit and Epogen, than any other drug, spending nearly $1.2 billion in 2004, according to a 2006 article in the American Journal of Health-System Pharmacy. Hospitals spent nearly $380 million on Aranesp, which ranked third among hospital drug expenses.

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March 12, 2007

Yes, I'm upset, but not totally surprised. I got a pamphlet from a chemo nurse when they first started giving them to me. It outlined the side effects, but no real dangers. I looked at the websites when i started getting all that pain, but again, no dangers listed. Hopefully all that will change now, and people will be better informed. You're right, there are NO drugs without side effects...

Cyndi

In a message dated 3/12/2007 2:39:33 P.M. Pacific Daylight Time, barbara3 writes:

My God, Cyndi.... Hugs and I'm sorry Those drugs were in question since 1997? And your doctor gave them to you knowing that they do not work and may make your cancer worse? How criminal is that?

Sorry for being cynical but I wonder how much money did she receive from that Amgen for her to prescribe those drugs....

In my opinion no doctor can be trusted especially the younger ones.

Everybody, please remember that there are NO drugs without side effects and the newer the drug the worse damage it does to people. Big pharma under this administration went completely berserk and it seems there is no stopping that greed So criminal!

Barbara