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FDA Public Health Advisory
Sepsis and Medical Abortion
November 4, 2005 Update:
All four cases of fatal infection tested positive
for Clostridium sordellii. In addition, FDA tested drug
from manufacturing lots of mifepristone and misoprostol and found no
contamination with Clostridium sordellii.
July 19, 2005: The Food and Drug Administration (FDA) is aware of
four cases of septic deaths in the United States, from September
2003 to June 2005 in women following
medical abortion with mifepristone (Mifeprex) and misoprostol. The
bacteria causing sepsis has been identified in two of the cases as
Clostridium sordellii. The other two cases are under ongoing
investigation by FDA along with the Centers for Disease Control and
Prevention, State and local health departments, and the manufacturer
of Mifeprex. All cases involve the off-label dosing regimen
consisting of 200 mg of oral Mifeprex followed by 800 mcg of
intra-vaginally placed misoprostol. The two confirmed cases of
Clostridium sordellii did not have the usual signs and symptoms
of an infection. Although these deaths are reported
from California, all providers of medical abortion and their
patients need to be aware of the risks of sepsis. As more
information becomes available, FDA will alert the public.
In the meantime, FDA recommends that healthcare professionals and
patients be aware of the following:
-
All providers of medical abortion and emergency room
health care providers should investigate the possibility of sepsis
in patients who are undergoing medical abortion and present with
nausea, vomiting, or diarrhea and weakness with or without abdominal
pain, and without fever or other signs of infection more than 24
hours after taking misoprostol. To help
identify those patients with hidden infection, strong consideration
should be given to obtaining a complete blood count.
-
FDA recommends that physicians suspect infection in
patients with this presentation and consider immediately initiating
treatment with antibiotics that includes coverage of anaerobic
bacteria such as Clostridium sordellii.
-
At this time FDA does not have sufficient
information to recommend the use of prophylactic antibiotics.
Reports of fatal sepsis in women undergoing medical abortion is very
rare (approximately 1 in 100,000). Prophylactic antibiotic use
carries its own risk of serious adverse events such as severe or
fatal allergic reactions. Also, prophylactic use of antibiotics can
stimulate the growth of “superbugs,” bacteria resistant to everyday
antibiotics. Finally, it is not known which antibiotic and regimen
(what dose and for how long) will be effective in cases such as the
ones that have occurred.
-
The approved Mifeprex regimen for a medical abortion
through 49 days’ pregnancy is:
-
Day One: Mifeprex Administration: 3 tablets of 200
mg of Mifeprex orally at once
-
Day Three: Misoprostol Administration: 2 tablets of
200 mcg of misoprostol orally at once.
-
Day 14: Post-Treatment: the patient must return to
confirm that a complete termination has occurred. If not, surgical
termination is recommended to manage medical abortion treatment
failures.
-
The safety and effectiveness of other Mifeprex
dosing regimens, including use of oral misoprostol tablets
intravaginally has not been established by the FDA.
These recommendations are consistent with warnings
in the Prescribing Information and information for the patient in
the Medication Guide.
FDA is also working with the manufacturers of Mifeprex and
misoprostol tablets to conduct special tests to ensure that there
was no
contamination of either product with Clostridium sordellii.
Information pertaining to Mifeprex can be found at
http://www.fda.gov/cder/drug/infopage/mifepristone/default.htm
FDA will update this advisory as more definitive information becomes
available.
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Date created: July 19, 2005; updated July 22, 2005, updated
November 4, 2005 |
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