It is FDA-approved as a method of medical abortion. The brand name for RU is Mifeprex, and its generic name is mifepristone. To use RU, you must see a medical professional. Using the abortion pill involves a two-step process that involves taking two different medicines that work to end a pregnancy.
It is important to note that the abortion pill is not the same thing as the morning-after pill. If you choose to use the abortion pill, there are three steps in the process :. If the abortion pill didn't work, your healthcare provider will discuss your options with you. You may need an additional dose of medication or a procedure to complete the abortion. RU blocks the progesterone receptors in your body. Progesterone is the hormone responsible for causing the uterine lining to build up and prepare for pregnancy.
The mifepristone causes the lining of your uterus to shed—so your pregnancy can no longer continue because the egg will have nothing to stay attached to. Then, the misoprostol will cause uterine contractions.
This allows your uterus to be emptied. The FDA has approved RU for women up to 7 weeks pregnant or 5 weeks since conception or up to 49 days after their last menstrual period.
Although some healthcare providers will still prescribe RU for women who are more than 7 weeks pregnant, this use is considered off-label meaning it is not FDA-approved at this stage. You should expect to feel some side effects after using the abortion pill.
If you have severe pain or feel faint, get medical attention. And if you have a fever after the day you take the misoprostol, call your healthcare provider.
Within four or five hours after taking the mifepristone, more than half of women's pregnancies will be terminated. For others, it may take a little longer, but the abortion should take place within a few days. You can expect to see clots of blood when this happens, and the cramping may continue intermittently for a few days. You can become pregnant again right after using the abortion pill, so make sure that you are using backup contraception. Also, know that RU does not offer protection against sexually transmitted diseases.
It is normal to have some bleeding or spotting for up to four weeks after using the abortion pill. It is recommended that you do not insert anything into your vagina or have sex for at least seven days after using the abortion pill. The bleeding after your abortion marks the start of a new menstrual cycle. This means that your normal period should return in four to eight weeks. In the remaining cases, women experienced continuing pregnancies, incomplete abortions, or other complications and received safe and common first-trimester surgical abortions.
Overall, only 0. Only about half of these hospitalizations were related to the drugs; others were due to unrelated events such as automobile accidents and infectious diseases. There were no deaths reported. The French trials showed the drug combination to be The Population Council submitted its application for mifepristone's approval to the FDA in March , following clinical trials that began in The FDA issued final approval of mifepristone in September The FDA approved mifepristone after carefully reviewing three complete phases of clinical trials-the standard review process-that took place in the U.
Based on the data from these studies, the FDA concluded that the drug is safe and effective. According to the FDA, the average review time for an "innovative" new drug-unlike mifepristone, which has been extensively tested-is 6 months or less. The agency took considerably more time in approving mifepristone.
MYTH: With mifepristone available, more women will have abortions. FACT: In countries where mifepristone has been available for many years, the overall abortion rate has not increased. The FDA has reviewed this information and did not identify any new safety signals. The FDA intends to update this summary report on an annual basis or as appropriate. As with all approved drugs, when the FDA receives new information regarding adverse events, the agency reviews the new information and, as appropriate, takes necessary action, including providing updates to healthcare providers and their patients so that they have information on how to use the drug safely.
All providers of medical abortion and emergency room healthcare practitioners should investigate the possibility of sepsis in women who are undergoing medical abortion and present with nausea, vomiting, or diarrhea and weakness with or without abdominal pain. These symptoms, even without a fever, may indicate a serious infection. Strong consideration should be given to obtaining a complete blood count in these patients. Significant leukocytosis with a marked left shift and hemoconcentration may be indicative of sepsis.
This information applies equally to Mifeprex and the approved generic version of Mifeprex. It is possible for a woman to become pregnant again soon after a pregnancy ends. If a woman who has terminated a pregnancy does not want to become pregnant again, she should start taking appropriate precautions after the pregnancy ends.
A woman should consult with her healthcare provider regarding any specific questions she may have. Mifepristone for termination of pregnancy has been approved in France since , and also is approved in the United Kingdom, Sweden, and approximately 60 other countries.
Manufacturers, distributors, and retailers establish the prices. Additionally, the FDA has no input into or legal control over whether an insurance company does or does not cover the cost of a drug. Insurance coverage is a decision made by an insurance provider.
This determination, which FDA made on April 12, , is effective immediately. Further, to the extent all of the other requirements of the Mifepristone REMS Program are met, the Agency intends to exercise enforcement discretion during the COVID PHE with respect to the dispensing of Mifeprex or the approved generic version of Mifeprex, Mifepristone Tablets, mg, through the mail, either by or under the supervision of a certified prescriber, or through a mail-order pharmacy when such dispensing is done under the supervision of a certified prescriber.
Index to Drug-Specific Information. What is Mifeprex and how does it work? Is there a generic version of Mifeprex? Who should not take Mifeprex? A woman should not take Mifeprex if it has been more than 70 days since the first day of her last menstrual period, or if she: has an ectopic pregnancy a pregnancy outside of the uterus has problems with the adrenal glands the glands near the kidneys is currently being treated with long-term corticosteroid therapy medications has had an allergic reaction to mifepristone, misoprostol or similar drugs has bleeding problems or is taking anticoagulant blood thinning drug products has inherited porphyria has an intrauterine device IUD in place it must be removed before taking Mifeprex.
This information applies equally to the approved generic version of Mifeprex. Find more information here: Mifeprex mifepristone Information Of note, on April 11, , FDA approved a supplemental application for Mifeprex, approving modifications to the existing approved REMS for Mifeprex to establish a single, shared system REMS for mifepristone products including Mifeprex as well as the approved generic version of Mifeprex for the medical termination of intrauterine pregnancy through 70 days gestation.
0コメント