Dr. JOSHUA OFMAN (Vice President, Amgen): The FDA label acknowledges that a certain risks cannot be excluded, but they have clearly stated that the lowest dose should be use to avoid transfusion with an upper safety limit of 12, leaving some discretion for physicians to make those determinations based on their individual patient needs.

NPR: Doctors in Medicare Fight Over Right to Prescribe

Instead, he found it had failed to operate at maximum allowable operating pressure--odd, given that this pressure is usually the upper limit for safety and El Paso was under federal restrictions after an August 2000 pipeline explosion killed 12 campers in New Mexico.

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