|The Food and Drug Administration has issued an alert entitled Mifeprex (mifepristone) Information:|
||"FDA is aware of four women in the United States who died from sepsis (severe illness caused by infection of the bloodstream) after medical abortion with Mifeprex and misoprostol."
Read FDA alert
The Centers for Disease Control and Prevention have issued a public notice entitled Clostridium sordellii Toxic Shock Syndrome After Medical Abortion with Mifepristone and Intravaginal Misoprostol:
||"Investigation by FDA, CDC, and state and local health departments into the two most recently identified U.S. deaths after medical abortion is ongoing. Empiric therapy for patients suspected of having postpartum or postabortion toxic shock syndrome should include antimicrobials with anaerobic activity against Clostridium species."
Read CDC notice
Danco Laboratories announced that it is modifying the labeling for Mifeprex to
include updated safety information:
| ||"Danco has received reports of five deaths from serious bacterial infection and sepsis following treatment with Mifeprex and misoprostol ... Women who are undergoing a medical abortion with the Mifeprex and misoprostol regimen should
contact their provider or an emergency room right away if they experience abdominal pain or discomfort
or general malaise (including weakness, nausea, vomiting or diarrhea), with or without fever, more than
24 hours after taking misoprostol.
Read full Danco press release (PDF)
The manufacturer of Cytotec, G.D. Searle (now part of the Pharmacia Corporation), recommends that Cytotec not be used for abortion:
| ||"Searle regards the administration of misoprostol, either alone or in combination with other drugs to interfere with the course of pregnancy, as misuse of the product. ... We strongly condemn misuse of the product."68|
Note: Cytotec is an anti-ulcer drug, intended for patients at risk of developing stomach ulcers from high doses of aspirin-like medications taken for conditions such as arthritis.
On August 23, 2000 Searle issued a letter to all Health Care Practitioners entitled "Important Drug Warning Concerning Unapproved Use of Intravaginal or Oral Misoprostol in Pregnant Women for ... Abortion." It states in part:
Serious adverse events reported following off-label use of Cytotec in pregnant women include maternal and fetal death; uterine hyperstimulation, rupture or perforation requiring uterine surgical repair, hysterectomy [removal of uterus] or salpingo-oophorectomy [removal of ovaries and Fallopian tubes]; amniotic fluid embolism; severe vaginal bleeding, retained placenta, shock, fetal bradycardia and pelvic pain.69 |
The "black box" warnings on Cytotec's label state in part:
UTERINE PERFORATION HAS BEEN REPORTED FOLLOWING ADMINISTRATION OF COMBINED VAGINAL-AND-ORAL CYTOTEC IN PREGNANT WOMEN TO INDUCE ABORTION. IN EACH OF THESE REPORTED CASES, THE GESTATIONAL AGE OF THE PREGNANCIES WAS UNKNOWN.
68 Letter to the Editor, signed W. Wilson Downie, International Medical Operations, G.D. Searle, The Lancet, vol. 338:247 (July 27, 1991).
69 Letter from Michael Cullen, MD, Searle's U.S. Medical Director, dated August 23, 2000, available at http://www.fda.gov/medwatch/safety/2000/cytote.htm.