Fatal infection caused death in Mifeprex cases
A just-published report in the New England Journal of Medicine (NEJM) finds that the deaths of four California women who took the abortion drug Mifeprex (mifepristone, Danco Laboratories, New York City) were linked to toxic shock caused by the bacterium Clostridium sordellii, but the risk of infection in conjunction with taking the drug is "low," state epidemiologists who reviewed the cases.1
About 510,000 women in the United States have used Mifeprex since it received Food and Drug Administration (FDA) approval in 2000. In July 2005, the drug’s safety labeling was revised and health care providers were alerted with an FDA public health advisory highlighting the risk of sepsis or blood infection when undergoing medical abortion using Mifeprex and misoprostol in a manner not consistent with the approved labeling.
The new NEJM report and a companion commentary put into perspective the fact that C. sordellii infections are very rare and have been reported in the literature in obstetric and gynecologic circumstances including after childbirth, medical abortion, and other nonpregnancy-related conditions, says Cynthia Summers, DrPH, Danco Laboratories’ director of marketing and public affairs. The commentary was written by Michael Greene, MD, professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School and director of obstetrics at Massachusetts General Hospital, both in Boston.
"I think it is clear after reading both pieces that medical abortion is a safe and important option for women who are facing an unintended pregnancy," states Summers. "It is associated with the same risks as a natural miscarriage and is many times safer than carrying a pregnancy to term."
The new report found no direct link between the deaths of the four women, who received prescriptions at different California clinics between 2003 and 2005. It also found that the drugs they received came from different manufacturing lots.
One common element in all four deaths was the fact that the women used intravaginal administration of misoprostol in the medical abortion regimen, which differs from the FDA-approved regimen. The FDA-approved regimen calls for the following administration:
- Day One: Three tablets of 200 mg Mifeprex orally at once.
- Day Two: Two tablets of 200 mcg misoprostol orally at once.
- Day 14: The patient must return to confirm that a complete termination has occurred.
Look for symptoms
Clostridium sordellii is a gram-positive, toxin-forming anaerobic bacteria. To improve diagnosis and therapy, clinicians should be aware of the distinctive features of toxic shock syndrome associated with such infection, including:
- tachycardia;
- hypotension;
- edema;
- hemoconcentration;
- profound leukocytosis;
- and absence of fever.
Health care providers should report to their state or local health department any cases of toxic shock syndrome occurring after an abortion or associated with pregnancy, say state epidemiologists in the NEJM report.2
"Be vigilant for atypical presentations of endometritis," suggests Vanessa Cullins, MD, MPH, vice president for medical affairs at Planned Parenthood Federation of America in New York City. "See a woman immediately for clinical evaluation if her clinical course does not seem typical."
The Mifeprex web site, www.earlyoptionpill.com, offers prescribing information, a medication guide, and a patient agreement that reflects the new information on Clostridium sordellii toxic shock syndrome, says Summers. All of these materials describe the symptoms that patients and providers should look for and advise patients to call their provider right away if they experience any of those symptoms, she notes.
Many unanswered questions remain, says Summers. "Danco is still working closely with the FDA, CDC and other medical experts to try and understand the circumstances surrounding these events, and we fully support ongoing investigation and discussion of Clostridium sordellii infections in general, including the infections in the four women who died after medical abortion," states Summers.
References
- Fischer M, Bhatnagar J, Guarner J, et al. Fatal toxic shock syndrome associated with Clostridium sordellii after medical abortion. N Engl J Med 2005; 353:2,352-2,360.
- Greene MF. Fatal infections associated with mifepristone-induced abortion. N Engl J Med 2005; 353:2,317-2,318.
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