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SILVER SPRING, Md. (AP) - Two months after federal regulators ordered additional warnings be added to the labels of blockbuster anemia drugs, government advisers said Thursday Amgen Inc. and Johnson & Johnson should be required to add more warnings and conduct additional safety studies.
The Food and Drug Administration's outside panel of experts voted overwhelmingly in favor of expanding warnings about the risks of death, blood clots and other side effects for Amgen's Aranesp and Johnson & Johnson's Procrit.
Wall Street analysts said prior to the meeting that the biggest threat to the revenue the companies get from these drugs would be if panelists wanted to add warning labels that would limit prescribing the drugs to certain patients.
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