Misoprostol linked to deaths with off-label use

At least eight women have died from shock complications of an acute Clostridial infection following a medical abortion using a combination of mifepristone (Mifeprex) and misoprostol (Cytotec).

A new animal trial linked misopristol, the abortion drug used orally in combination with RU-486, to fatal infections in seven of the women. These seven women used the drug as a vaginal suppository, rather than as an oral agent. The drug has been deemed safe when given orally, but its off-label use might cause immune system suppression that allows a certain bacterium to achieve deadly virulence.

According to Arnoff, "When the drug is given orally, it does not appear to have a suppressive effect on reproductive tract immunology." However, "If the drug is applied directly to the reproductive tract, that's where we can see suppression of the immune system." The study appears in the online version of the Journal of Immunology. The researchers found that misoprostol--when used off-label--dramatically increased the virulence and lethality of the bacteria by about 50-fold.

- see the story on Med Page Today
- read the Journal of Immunology study abstract