Europe starts safety review of anemia drugs

Europe starts safety review of anemia drugs

By Steve Goldstein, MarketWatch
Last Update: 7:30 AM ET Apr 27, 2007

LONDON (MarketWatch) -- Europe's drug agency on Friday announced a safety review of anemia drugs, as it responded to studies suggesting heart risks in those taking the drugs.
The European Medicines Agency is reviewing drugs made by Amgen, Shire and Roche Holdings.
It's also cooperating on a review of the Eprex drug made by Johnson & Johnson. Eprex is known by the name Procrit in the United States.
"The safety review has been initiated because new data from both unpublished and published studies suggest an increased risk of serious cardiovascular complications in patients with chronic renal failure and a possible effect on tumor progression in cancer patients," it said.
The European regulator recommends that the drugs be used strictly in accordance with the label, that physicians exercise caution in prescribing when raising hemoglobin concentrations and that the drugs not be recommended for those not taking chemotherapy.
The U.S. Food and Drug Administration in March gave a public health advisory on the same class of drugs. Read external link to FDA warning. Read MarketWatch story on U.S. warning.
The New York Times reported in February that the anemia drugs have combined sales of $11 billion and have been heavily promoted in television commercials.
Roche's shares declined 1.1% in Switzerland and Shire was flat in London trading.
Amgen and Johnson & Johnson have yet to trade.
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Steve Goldstein is MarketWatch's London bureau chief.