Be on the lookout for signs of sepsis in female patients

Cases may present without fever

Due to five deaths from serious bacterial infection and sepsis after use of mifepristone (Mifeprex, manufactured by New York City-based Danco Laboratories) and misoprostol for nonsurgical abortion, the drug’s manufacturer has revised the safety information for the drug’s label and issued a letter to ED directors. (Editor’s note: To read the letter, go to

The deaths occurred from September 2000 through June 2005, with more than 460,000 estimated users during that time.

Be on the lookout for women of childbearing age who present with some or all of the following complaints: excessive vaginal bleeding, stomach or pelvic pain, weakness, dizziness, nausea, vomiting, and/or diarrhea, with or without fever, reports Gail McWilliams, RN, CCRN, CEN, clinical nurse specialist for the ED at Shore Health System in Cambridge, MD.

"The most recent cases mentioned all presented without fever," she notes. "The three cases that were reported to the FDA demonstrated refractory hypotension, multiple pleural effusions, hemoconcentration, and profoundly elevated white blood cell counts."

Any woman presenting with a recent history of taking mifepristone and any or all of these complaints should be triaged as an emergent and suspected of having an evolving septic shock until proven otherwise, says McWilliams. "If ED physicians are unaware of the connection, it is nursing’s role as a patient advocate that makes it imperative to push for rapid assessment and symptomatic treatment," she stresses.

Triage nurses should be aware of the potential for serious consequences if a patient states she has taken mifepristone, says Mary G. Kelley, MS, ARNP, CEN, triage coordinator for the ED at Carondelet St. Mary’s Hospital in Tucson, AZ. "We have a protocol for sepsis to help identify and prompt bed placement," she says. "Someone who came in with symptoms of sepsis would meet the criteria, would be promptly placed, and the sepsis initiative started."

The ED’s sepsis protocol does specify fever as a criteria, but ED nurses have been alerted about the fact that these cases may present without fever, says Kelley.

Because symptoms may be ambiguous, careful history taking is key, says McWilliams. "Many women forget to mention birth control pills, shots, or patches when asked about regular medications," she says.

Ask every woman of potential childbearing age about any medications related to contraception, says McWilliams. "It is only by knowing that a woman has taken mifepristone and misoprostol that a health care provider can make the connection and diagnose a potentially fatal disease process," she says.

For more information about the recent cases of sepsis, contact:

  • Mary G. Kelley, MS, ARNP, CEN, Triage Coordinator, Emergency Department, Carondelet St. Mary’s Hospital, Tucson, AZ. Telephone: (520) 872-2422. E-mail:
  • Gail McWilliams, RN, CCRN, CEN, Clinical Nurse Specialist, Emergency Department, Shore Health System, Cambridge, MD. Telephone: (410) 822-1000, ext. 8019. E-mail: