Amgen and Johnson & Johnson strengthened the label warnings for their widely used anaemia drugs yesterday, placing further emphasis on the risk that the medicines could cause heart attacks, a worsening of cancer and death.
The changes, made in consultation with the Food and Drug Administration, come after a year in which accumulating data have suggested that the drugs — Amgen’s Epogen and Aranesp, and Johnson & Johnson’s Procrit — can be dangerous if overused.
The new warnings also state for the first time that the drugs’ risks for cancer patients cannot be excluded even at doses previously considered safe and routinely used.
The warnings could contribute to a decline in use of the drugs that is already well under way. But analysts said in general that the new labeling was not as restrictive as it could have been.
James F. Reddoch, an analyst at Friedman, Billings, Ramsey, called the label changes “not bad,” and said in a note to clients that it was now less likely that insurance companies would further restrict reimbursement for the drugs.
More at NYT
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