Sixteen years of overregulation: time to unburden Mifeprex
Mifeprex REMS Study Group - New England Journal of Medicine, 2017 - Mass Medical Soc
Mifeprex REMS Study Group
New England Journal of Medicine, 2017•Mass Medical Soc… When Mifeprex was first approved 16 years ago, documented experience with its use outside
a research context was minimal, and the restrictions to minimize potential harm were perhaps
understandable. Since then, however, its effectiveness and safety have been definitively
established. To date, 19 deaths have been reported to the FDA among the more than 3 million
women in the United States who have used Mifeprex (Long A, Danco Laboratories: personal
communication); the estimated Mifeprex-associated mortality rate is thus 0.00063%. In contrast …
a research context was minimal, and the restrictions to minimize potential harm were perhaps
understandable. Since then, however, its effectiveness and safety have been definitively
established. To date, 19 deaths have been reported to the FDA among the more than 3 million
women in the United States who have used Mifeprex (Long A, Danco Laboratories: personal
communication); the estimated Mifeprex-associated mortality rate is thus 0.00063%. In contrast …
This Sounding Board article argues against the need for the currently required Risk Evaluation and Mitigation Strategy (REMS) for the drug Mifeprex for abortion, given the very low rate of adverse events associated with its use.
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