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Mifeprex/misoprostol linked to severe reactions. (Cases Involved Vaginal Misoprostol).
Serious adverse events, including two fatalities, have been reported in women who received the combination of Mifeprex and misoprostol for pregnancy termination.
All of the cases were in patients who were given misoprostol vaginally. The drug is approved only for oral administration. A cause-and-effect relationship has not been established between these events and vaginal administration of misoprostol.
In a "Dear Health Care Provider" letter, Danco Laboratories, the distributor of Mifeprex (mifepristone), said that it had received a "small number" of reports of ruptured ectopic pregnancies in women who received the Mifeprex-misoprostol regimen, including one fatality that was caused by hemorrhage of the ruptured ectopic pregnancy A Danco spokeswoman told this newspaper that three ruptured ectopic pregnancies had been reported. The letter emphasized that a confirmed or suspected ectopic pregnancy is a contraindication to Mifeprex and should be ruled out before starting the regimen.
There also have been two cases of serious systemic bacterial infections, including one fatality, in women who received Mifeprex and misoprostol. Danco stated in its letter that although ...
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