FDA may limit anemia drug use for kidney disease

Oct 14, 2010 By MATTHEW PERRONE , AP Health Writer

(AP) -- The Food and Drug Administration is considering new restrictions on widely used anemia drugs that appear to double the risk of stroke in patients with kidney disease.

The FDA posted its safety review of the three blood-boosting medications from Amgen Inc. on Thursday, focusing on their use in patients with chronic who are not yet sick enough to receive dialysis.

The medicines - Procrit, Aranesp and Epogen - are multibillion dollar sellers because of their ability to boost oxygen-carrying , reducing the need for painful blood transfusions. But sales have fallen sharply since 2007, when the FDA added the first of several safety warnings to the drugs, based on evidence they can cause tumor growth and hasten death in cancer patients. The drugs are no longer used in patients with several types of cancers.

Anemia, which causes weakness and shortness of breath, is a side effect of chemotherapy and .

Now the FDA is reviewing a study published last year that showed kidney disease patients taking Aranesp were twice as likely to experience stroke compared with those taking a dummy treatment. The goal of the study was to show that the drug could prevent heart attack, stroke and other heart-related problems, as had been assumed for years.

But FDA reviewers, using the chemical name for Aranesp, said in their posting that the "evidence raises considerable doubt about the safety and advisability of using darbepoetin in this manner."

Amgen has argued that its drugs should continue to be used because they help avoid blood transfusions, which carry their own risks. But the FDA's scientists point out that 15 percent of patients who took the company's drug still needed transfusions, compared with 25 percent of those taking a .

"Treatment did not eliminate the risk of requiring (red blood cell) transfusions," states the FDA review.

On Monday the agency will ask a panel of outside experts to review the data and make recommendations on how to safely use the drugs. Panelists could recommend bolstered warning labels, additional studies or lower doses of the drugs. The FDA is not required to follow the group's advice, although it often does.

Amgen, based in Thousand Oaks, Calif., makes all three drugs. Procrit is sold by Johnson & Johnson's Centocor Ortho Biotech division, under a long-standing agreement between the companies.

Last year the drugs - known as erythropoiesis stimulating agents - had combined sales of $6.3 billion, according to health data firm IMS Health.

Pre-dialysis kidney patients contributed 30 percent of Aranesp's revenue last year, estimates Robyn Karnauskas, an analyst at Deutsche Bank. New FDA restrictions would shave $86 million in sales off the drug, he estimates, which would have a minimal effect on Amgen's revenue. Amgen, one of the giants of the biotech drug industry, had total revenue exceeding $14.6 billion last year.

Explore further: More than a quarter of emergency contraceptives in Peru falsified or substandard

not rated yet
add to favorites email to friend print save as pdf

Related Stories

Study finds stroke risk from anemia drug Aranesp

Oct 31, 2009

(AP) -- A new study raises fresh safety concerns about widely used anemia medicines, finding that the drug Aranesp nearly doubled the risk of stroke in people with diabetes and chronic kidney problems who are not yet sick ...

Anemia drugs under scrutiny

Mar 13, 2008

U.S. drug regulators are contemplating further restrictions on the use of drugs to combat anemia in cancer patients.

FDA questions safety of Glaxo kidney cancer drug

Oct 01, 2009

(AP) -- Federal regulators said Thursday an experimental kidney cancer drug from GlaxoSmithKline may cause liver problems, potentially outweighing its ability to slow the disease.

Recommended for you

Study recalculates costs of combination vaccines

Apr 17, 2014

One of the most popular vaccine brands for children may not be the most cost-effective choice. And doctors may be overlooking some cost factors when choosing vaccines, driving the market toward what is actually a more expensive ...

Drug watchdog urges vigilance in cancer drug theft

Apr 17, 2014

Europe's medicine watchdog urged doctors Thursday to be vigilant in administering the cancer drug Herceptin, vials of which had been stolen in Italy and tampered with before being sold back into the supply chain.

User comments : 0

More news stories

Treating depression in Parkinson's patients

A group of scientists from the University of Kentucky College of Medicine and the Sanders-Brown Center on Aging has found interesting new information in a study on depression and neuropsychological function in Parkinson's ...

Impact glass stores biodata for millions of years

(Phys.org) —Bits of plant life encapsulated in molten glass by asteroid and comet impacts millions of years ago give geologists information about climate and life forms on the ancient Earth. Scientists ...

Researchers successfully clone adult human stem cells

(Phys.org) —An international team of researchers, led by Robert Lanza, of Advanced Cell Technology, has announced that they have performed the first successful cloning of adult human skin cells into stem ...