FDA May Launch Safety Review of RU 486

On the occasion of the tragic deaths of two women after having taken the abortion pill Mifepristone (Mifeprex™), also known as RU486, some Republicans in Congress are demanding that the Federal Drug Administration launch a special safety review of the drug. Anti-choice advocates are demanding that the drug be banned. Seven deaths in North America have been attributed to RU486 although over one million women in the world have used the drug safely. In an announcement on their www site , Planned Parenthood points out that “at this time, none of those deaths have been directly attributed to mifepristone.” The deaths may be the result of a fast acting sepsis, a blood infection, clostridium sordelli, “a common soil bacterium that has shown up in a small number of obstetric and gynecological cases, including following childbirth and surgical abortion...it has been identified as a cause of pregnancy-associated toxic-shock syndrome.” (ref) According to a spokesperson for the FDA, “four cases were women who had received this treatment vaginally, who then ... reported back to their physician with very serious, rapidly spreading infection which led to sepsis and death.” As a precautionary measure, Planned Parenthood announced that it would change the protocol for the second dose: “Our health centers will no longer recommend the option of administering misoprostol vaginally (misoprostol is the second drug in the two-drug medication abortion regimen). Patients will now receive misoprostol orally or buccally (where the pill is placed between the cheek and gum and dissolves). This change in protocol is effective immediately.” For information on the RU 486 debate see: http://www.religioustolerance.org/aboru486f.htm