About Mifeprex (mifepristone) and Misoprostol
Mifeprex (mifepristone) is an oral tablet given for the termination of pregnancy and is commonly known as the "abortion pill" or the "morning after drug." Developed in Europe and known there as RU-486, Mifeprex was approved for sale in the U.S. in 2000 and has since been used in more than 560,000 medical abortions in the U.S.
Mifeprex works by blocking progesterone, a hormone essential to maintain a pregnancy. When progesterone is suppressed, the lining of the uterus softens and then disintegrates. Two days after Mifeprex is taken, the patient is given a dose of Misoprostol, which induces contractions in the womb. The patient then expels the lining of the uterus and the early embryo, a process known as a medical abortion.
Known Side Effects of Mifeprex
Mifeprex has several well-known side effects, including heavy bleeding and cramping that may persist as long as 9-16 days. In as many as 1 out of 100 women, which accounts for 5% of the female population, the bleeding may be severe enough to require a surgical procedure known as cutterage. In the serious death cases reported with Mifeprex, women died from septic shock after taking Mifeprex.
What is Septic Shock?
A serious bacterial infection is one that spreads through the body and is considered to have the potential to threaten the life of a patient. In rare cases, severe bacterial infection can lead to septic shock or death.
Septic shock is the medical term for the condition of a patient's body as a result of an overwhelming systemic bacterial infection. The patient's system is literally in a state of shock from decreased blood pressure and blood flow in the body. Septic shock, or sepsis, is a medical emergency because the body's vital organs such as the brain, heart, kidneys, lungs, and liver will not function properly and can fail.
FDA Confirms Four Deaths from Mifeprex in July 2005
After confirming four cases of septic deaths in the U.S. in women following medical abortion procedures utilizing Mifeprex, the U.S. Food and Drug Administration issued a Public Health Advisory about the risks of sepsis from medical abortions involving Mifeprex. All four deaths involve an off-label dosing regimen consisting of 200 mg of oral Mifeprex followed by 800 mcg of intra-vaginally placed misoprostol. In two of the cases, it was confirmed that the bacteria causing the sepsis was Clostridium sordellii, but the women who died did not show the usual signs and symptoms of an infection from this bacteria.
The FDA warns that health care professionals, physicians and patients be aware of the following recommendations:
- "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, diarrhea, or weakness with or without abdominal pain and without fever or other signs of infection. To help identify those patients with hidden infections, strong consideration should be given to obtaining a complete blood count."
- Physicians suspecting infection in patients should immediately consider treatment with antibiotics that includes coverage of anaerobic bacteria such as Clostridium sordellii.
- The safety and effectiveness of other Mifeprex dosing regimens, including use of oral misoprostol tablets intra-vaginally, has not been established by the FDA.
- Approximately 460,000 women in the U.S. have used Mifeprex, putting the current known risk of sepsis infection at 1 in 100,000.
FDA-Approved Dosing Regimen for Mifeprex
The approved Mifeprex/Misoprostol regimen for a medical abortion through 49 days' pregnancy is:
- Day One Mifeprex Administration: 3 tablets of 200 mg of Mifeprex orally
- 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.
What is the Relationship between Mifeprex/Misoprostol and Clostridium sordellii?
The U.S. Food and Drug Administration has not found any causal relationship between the RU-486 regime of Mifeprex and Misoprostol and the bacteria identified in four patient deaths, Clostridium sordellii. Clostridium sordellii is a common vaginal bacterium that is not usually fatal. However, Brown University professor Ralph P. Miech, MD, PhD, proposed two models in which a causal relationship might exist between the drug regimen and the presence of the bacteria in the women who died in a paper published in the September, 2005, edition of The Annals of Pharmacotherapy.
In one scenario proposed by Dr. Miech's article, the antiprogesterone effects of Mifeprex (mifepristone) also cause changes in the cervix that can allow Clostridium sordellii to enter the low oxygen environment of the cervical canal, taking vital nutrients away from the fetal tissue in the womb. At the same time, other hormonal effects of mifepristone, known as antiglucocorticoid actions, take place throughout the body . These antiglucocorticoid actions may interfere with vital chemical regulators in the body called cytokines, weakening the immune system by suppressing the body's natural inflammation response and making it unable to fight off Clostridium sordellii or its toxic by-products. This may make the body susceptible to septic shock.
Symptoms of Serious Bacterial Infection
Although infection following medical abortion has been rare, the FDA has released an FAQ for medical providers to alert them to the possibility of infection in their patients. The following symptoms may be signs of severe bacterial infection and should not be ignored:
- sustained fever of 100.4 degrees Fahrenheit or higher
- severe abdominal pain
- pelvic tenderness
Adverse Events and RU-486
It has been reported that over 600 adverse events involving the Mifeprex/Misoprostol regimen have been reported to the FDA (Source:Newsinferno.com, March 18, 2006). There is concern that adverse events may be underreported because the FDA has not made a causal link between the drug and the fatal infections of women. If you know of someone who died after taking the abortion pill regimen of Mifeprex and Misoprostol, you may want to discuss your case with a lawyer. The Law Offices of James Scott Farrin is experienced in wrongful death cases. Call or contact us today for a free conversation about your situation. There is never any obligation to hire our law firm.
