Mifeprex (mifepristone)

Mifeprex (mifepristone) is an oral medication used to terminate early pregnancy. This medication, also known as RU 486, blocks a hormone (progesterone) which is needed for pregnancy to continue. When used together with another medicine called misoprostol, mifepristone causes an abortion to occur.

Once pregnancy is confirmed, a woman goes to her physician's office for the two doses of medication. First, she is given the dose of mifepristone, a synthetic steroid, which causes a fertilized egg to detach from the lining of the uterus. The second pill misoprostol, which causes uterine contractions, is taken two days later and terminates pregnancy within 6 hours to one week.

Why Prescribed

Mifeprex, sometimes referred to as non-surgical abortion, medical abortion, or RU 486, is prescribed to end early pregnancy.

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FDA Approved Uses

On September 28, 2000, the FDA announced the approval of Mifeprex, which is often referred to as the "abortion pill."

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Side Effects

Side effects associated with Mifeprex include uterine cramps, fatigue, nausea, and heavy bleeding. Patients should contact a healthcare professional right away if they have taken Mifeprex for medical abortion and develop stomach pain or discomfort, or have weakness, nausea, vomiting, or diarrhea with or without fever, more than 24 hours after taking the misoprostol. These symptoms, even without a fever, may indicate sepsis—a severe illness caused by infection in the bloodstream.

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Warnings and Alerts

Since the approval of mifepristone in September 2000, the FDA has received reports of deaths in the United States following medical abortion with mifepristone (Mifeprex) and misoprostol. An FDA black box warning was issued on July 19, 2005, informing health care providers that infections have occurred after patients have used Mifeprex. This came after four women in the United States died from sepsis after medical abortion with Mifeprex and misoprostol.  All four women were infected by the same type of bacteria, Clostridium sordelli.

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Drug Contraindications

Mifeprex is contraindicated in patients who use "blood thinners" (e.g., anticoagulants such as warfarin, or heparins), long-term corticosteroid therapy (e.g., prednisone), azole antifungals (e.g., ketoconazole, itraconazole), certain macrolide antibiotics (e.g., erythromycin), rifamycins (e.g., rifampin), dexamethasone, St John's wort, and/or certain anti-seizure drugs (e.g., phenytoin, phenobarbital, carbamazepine).  Patients should not eat grapefruit or drink grapefruit juice while taking Mifeprex, as it may increase the level of medicine in the blood and increase the risk of side effects.

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FAQ's

How effective is Mifeprex?

Mifeprex, when used in conjunction with misoprostol, is approximately 95-97% effective for the termination of early pregnancy.

What is sepsis, and how does it occur?

Sepsis is a severe life-threatening infection in the blood that spreads throughout the body and can cause death.

It has been reported that the rate of serious infection as a complication of pregnancy is 3.5 per 1000 pregnancies. Uterine infection occurs in 0.1-4.7% of first trimester surgical abortions and in 0.0-6.1% of medical abortions. In the past, sepsis was most often associated with illegal abortions. It rarely occurs with pelvic surgery or even with otherwise normal childbirth.

What is Clostridium sordelli and why is it included in the ‘Warnings’ section of the Mifeprex label?

Clostridium sordelli is a bacteria that is anaerobic (it can live without oxygen) and in very rare cases produces toxins that are rapidly fatal. Rare infections with Clostridium sordelli can occur following childbirth (vaginal delivery and caesarian section), as well as following medical abortions. The bacteria can also occur with abdominal or bone (orthopedic) surgery, and deep skin infections.

Should women undergoing medical abortion be using antibiotics to prevent fatal infections?

The FDA does not have sufficient information at this time to recommend the use of preventive antibiotics for women undergoing medical abortion. Preventive antibiotic use carries its own risk of serious adverse events such as severe or fatal allergic reactions. Also, preventive use of antibiotics can stimulate the growth of bacteria resistant to everyday antibiotics.

While the FDA cannot officially recommend preventive antibiotics to women undergoing medical abortion, it does advise physicians to administer antibiotics to patients suspected of having an infection in order to intercept and kill bacteria such as Clostridium sordelli, if it is at all present.

Can I bring a lawsuit if I have suffered injuries from taking Mifeprex?

If you have suffered serious side effects from using Mifeprex, such as infection or excessive bleeding, you may be entitled to recover damages. Manufacturers of dangerous drugs can be held legally liable for their products and associated negligence. Contact a qualified drug litigation attorney today, who can evaluate your case and explain your legal options.

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