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UPDATE 1-EU body warns on anaemia drugs in cancer patients

Thu Jun 26, 2008 2:43pm EDT
 
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(Adds Amgen comment)

LONDON, June 26 (Reuters) - Epoetin, or Epo, drugs should carry a new warning for their use in cancer patients stating that blood transfusion should be the preferred method of correcting anaemia, the European Medicines Agency said on Thursday.

The move, which follows a similar review by U.S. regulators, was prompted by new evidence showing an increased risk of tumour progression, venous thromboembolism and shorter overall survival in cancer patients who received epoetins than those who did not.

Experts at the London-based watchdog concluded that the benefits of epoetins continued to outweigh their risks in other approved indications. But in the case of cancer patients with a reasonably long life-expectancy, any anaemia should be corrected with transfusions.

Leading makers of Epo drugs include Amgen (AMGN.O: Quote, Profile, Research, Stock Buzz) and Johnson & Johnson (JNJ.N: Quote, Profile, Research, Stock Buzz).

Amgen said it continued to be "constructively engaged" with the European Medicines Agency, the U.S. Food and Drug Administration and other regulatory authorities on Epo drug labelling issues.

"We're looking forward to final label language later this year," a spokeswoman said. (Reporting by Ben Hirschler)

 

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