Off Label Use of Abortion Pill Linked to Deadly InfectionsJun 18, 2008 | Parker Waichman LLP
Early studies conducted by University of Michigan scientists point to rare, fatal infections in off-label use of misoprostol, a drug used to cause abortion. When taken orally, RU-486's companion drug—misoprostol—is safe; however, vaginal use may undermine the body's immune responses and is now believed to be linked to the deadly infections seen in women taking the drugs since 2000. Misoprostol is US Food and Drug Administration (FDA)-approved to be taken orally with RU-486 for pregnancy termination; however, many women have received the drug vaginally as part of a two-drug combination. The vaginal delivery method has not yet been evaluated by the FDA.
Lab research indicated that when misoprostol is administered directly in the reproductive tract, it weakened key immune defenses; suppressed macrophages, the immune cells that attack and kill bacteria; suppressed neutrophils; and inhibited other immune defenses such as production of anti-bacterial chemicals normally produced in the uterine lining. Administered vaginally, misoprostol also allows a normally non-threatening bacterium, Clostridium sordellii, to run amok and cause life-threatening infection. When administered orally and absorbed through the stomach, misoprostol did not mitigate immune defenses or cause illness.
Clostridium sordellii is being closely watched by the federal Centers for Disease Control and Prevention (CDC) and others not only because of links to abortion-related deaths, but because Clostiridium is biologically similar to Clostridium difficile—C. difficile or C. diff—and is responsibile for an rapidly increasing number of infections in healthcare settings.
The results further prove that doctors should not administer misoprostol vaginally, says David Aronoff, M.D, an assistant professor in the Department of Internal Medicine at the U-M Medical School. "The findings should help make a safe procedure even safer." In 2006, Planned Parenthood issued a warning advising doctors against off-label vaginal use of misoprostol in medication abortions; however, many clinicians and patients ignored the warnings and used misoprostol vaginally to avoid side effects often experienced when taking the drug orally.
There have been eight reported deaths after infections of Clostridium bacteria; misoprostol was administered vaginally in seven of the cases. Six of the eight women were infected with Clostridium sordellii; the other two contracted a related Clostridium bacterium.
Infections during pregnancy may be linked to pre-term births, stillbirths, and birth defects; globally, nearly seven million women develop infections during or after childbirth. Such infections cause one million premature births, stillbirths, and maternal deaths; preterm births are a growing problem. "Since infections are a great cause of illness and death in pregnancy, this seems to be a very ripe area to study in efforts to develop better preventive and therapeutic strategies against the complications of pregnancy," said Aronoff.
Misoprostol is a synthetic version of one of the body's immune response suppressors called prostaglandin E2 (PGE2), which balances active or overactive immune responses and increases in the reproductive tract during pregnancy. PGE2 are believed to stop a mother’s immune system from attacking the fetus as a foreign object. Some believe high PGE2 levels place women and their fetuses at increased vulnerability to certain microbes.