FDA Backtracking on RU-486

Sadly, this doesn’t really surprise me:

The Food and Drug Administration will announce today important new safety changes to the Danco Laboratories, LLC’s labeling of mifepristone (trade name Mifeprex, also known as RU-486). Mifeprex was approved in 2000 for the termination of early pregnancy, defined as 49 days or less. FDA and Danco Laboratories have received reports of serious bacterial infection, bleeding, ectopic pregnancies that have ruptured, and death, including another death from sepsis that was recently reported to FDA. These reports have led to the revision of the black box labeling.

The FDA’s release adds that “these risks are rare”. Yeah. Right. I have a real problem taking any drug that lists “serious bacterial infection” and “death” among its side effects, rare or not.

I don’t know enough about the approval process at FDA, or the history of the debate over RU-486, to comment. I just wonder whether the political issues involved with RU-486 had anything to do with bringing it to market.

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