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FDA Looks at Anemia Drugs, Cancer Risks

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    FDA Looks at Anemia Drugs, Cancer Risks Fri Mar 19,10:36 AM ET By Lisa Richwine WASHINGTON (Reuters) - U.S. regulators are considering whether two
    Message 1 of 1 , Mar 20, 2004
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      FDA Looks at Anemia Drugs, Cancer Risks
      Fri Mar 19,10:36 AM ET

      By Lisa Richwine

      WASHINGTON (Reuters) - U.S. regulators are considering whether two
      anemia-fighting drugs, often given to cancer patients, may in some
      cases stimulate tumor growth, a question raised by studies of similar
      products sold in Europe.

      The Food and Drug Administration (news - web sites) has scheduled a
      meeting of outside experts for May 4 to gather input on safety issues
      surrounding the medicines, Amgen Inc.'s Aranesp and Johnson &
      Johnson's Procrit.

      The agency still believes the drugs are safe, and a valuable
      alternative to blood transfusions, when used as directed for treating
      anemia in patients receiving chemotherapy.

      The treatments are bioengineered versions of a human protein,
      erythropoietin, that stimulates production of red blood cells.
      Combined sales of the anemia drugs, which are given by injection,
      amount to several billion dollars a year.

      The medicines are prescribed for patients with cancer, kidney disease
      and other ailments to treat anemia, a deficiency of red blood cells
      that causes fatigue and other symptoms.

      In the studies of the European products, the drugs were used
      differently to see if they might help fight cancer by boosting
      effectiveness of chemotherapy or radiation. Some patients received
      higher than normal doses, and some were not anemic.

      The FDA wants advice from its outside advisory committee on whether
      those studies are relevant to the U.S. products, and whether more
      research on possible tumor effects is needed, an agency official
      said.

      One study last year found patients undergoing radiation treatment for
      head and neck cancer had shorter survival times if they took Roche
      AG's NeoRecormon, the company's anemia treatment sold in Europe.

      Another trial of breast cancer patients undergoing chemotherapy was
      halted early because of higher mortality among those given Johnson &
      Johnson's Eprex, also sold in Europe. Survival at 12 months was 76
      percent in patients given a placebo, and 70 percent among patients
      treated with Eprex.

      Some deaths resulted from progression of cancer, and others from
      blood clots, a known risk, the researchers said.

      Researchers said the findings were not definitive but did raise
      concerns.

      Amgen has "fully examined all of our data, and we find no evidence of
      (tumor stimulation) with Aranesp," Amgen spokeswoman Kelly Stoddard
      said.

      She said the studies of the European products were not pertinent to
      Aranesp because they involved different drugs.

      Johnson & Johnson spokesman Mark Wolfe said the company was committed
      to providing patients and health-care providers "with the most
      complete and up-to-date information regarding the safe use of this
      important class of medications."

      He declined to comment further.

      Researchers do not know why the anemia drugs might prompt tumors to
      grow, but some theorize they might activate some receptors on tumors
      that help spur growth.


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