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The warning on three once-widely-used anemia drugs has been strengthened to highlight the risk of heart attack, worsening cancer, and death. The new changes expand on a black box warning added to the drugs earlier this year that urged doctors to exercise restraint when prescribing.
Procrit , Epogen, and Aranesp are used by more than one million Americans annually, though prescriptions have been declining since data began to suggest the drugs' dangers. The drugs are primarily used to treat anemia related to chemotherapy or kidney failure.
Earlier this year, concern started to mount regarding possible overuse of the three drugs, which are manufactured by Johnson & Johnson and Amgen. Dialysis centers in particular were accused of over-prescribing the drugs to boost profits.
Last year alone, global sales of the drugs reached nearly $10 billion. The profits came at a price, however. Data showed that excessive use of the drugs was linked to serious side effects in certain groups of patients.
The Food and Drug Administration has held two advisory panel meetings to discuss the drugs, their safety and their risks. In March, the agency added the strongest warning, a bold black box, to the drugs' labeling.
The new warning emphasizes the previous warning and also adds a new warning regarding risks for cancer patients taking doses considered safe.
(Source: The Wall Street Journal online)
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