Септический шок после медикаментозного прерывания беременности

[dr_medvedev]

Уважаемые коллеги кто практикует медикаментозное прерывание беременности. Обратите внимание на свежую информацию.

Off-Label Use of Abortion Drugs Linked to Silent Infection, Septic Deaths

Yael Waknine


July 20, 2005 — The U.S. Food and Drug Administration (FDA) and Danco Laboratories, LLC, have warned healthcare professionals regarding the risk of sepsis associated with use of an off-label regimen of mifepristone (Mifeprex, RU-486) and misoprostol for medical abortion, according to an alert sent today from MedWatch, the FDA's safety information and adverse event reporting system.

Since the approval of mifepristone in September 2000, the agency has received four reports of septic death in patients receiving 200 mg of oral mifepristone followed by 800 µg of intravaginally placed oral misoprostol. One additional death was reported during clinical trials in 2001.

Clostridium sordellii has been identified as the source of infection in the first three deaths; the microbes involved in the other two cases remain unknown. Presentation of infection was atypical in all five patients.

Although a causal role for the drugs and/or off-label regimen has not been established, physicians are urged to have a higher level of suspicion for sepsis in patients undergoing medical abortion who present with general malaise (including weakness, nausea, vomiting, or diarrhea) with or without abdominal pain and without fever or other signs of infection.

A complete blood count is recommended to determine the presence of hidden infection and an antibiotic regimen effective against anaerobes such as C. sordellii should be initiated immediately on confirmation.

At this time, the FDA is not recommending prophylactic treatment because of the low risk of sepsis associated with the regimen (approximately 1 in 100,000) and the inherent risks of antibiotic use such as severe or fatal allergic reactions and the development of "superbugs" (resistant bacteria). Furthermore, an appropriate antibiotic and regimen for this purpose have not yet been determined.

Mifepristone is indicated for the termination of pregnancies that have progressed for 49 days or less, as determined by the first day of the last menstrual period. The FDA-approved oral regimen consists of 600 mg of mifepristone administered on day 1 followed by 400 µg of misoprostol on day 3. Patients should be evaluated on day 14 to confirm the complete termination of pregnancy.

While some modified regimens have been well-described in the literature, their safety and effectiveness (including intravaginal use of oral misoprostol) have not been established by the FDA.

The FDA is continuing to work with the Centers for Disease Control and Prevention, state and local health departments, and the manufacturer to investigate these cases and to rule out product contamination with C. sordellii.

Adverse events related to use of mifepristone should be reported to Danco Laboratories by telephone at 1-877-432-7596, by email to [Ссылки доступны только зарегистрированным пользователям ], or by mail to Medical Director, Danco Laboratories, LLC, P.O. Box 4816, New York, NY 10185.

Alternatively, adverse events may be reported to the FDA's MedWatch program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at [Ссылки доступны только зарегистрированным пользователям ], or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.