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Drug Information Update: Mifeprex Questions and Answers

FDA/CDER/Division of Drug Information (DDI)

The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation byFDA.

1. What is MIFEPREX (mifepristone) and how does it work?

Mifepristone is a drug that blocks a hormone called progesterone that is needed for pregnancy to continue. Mifepristone, when used together with another medicine called misoprostol, is used to end an early pregnancy (49 days or less since your last menstrual period began).

2. Is mifepristone approved in any other countries?

Yes, mifepristone has also been approved in the United Kingdom,  Sweden and other countries.

3. Who should not take mifepristone?

Some women should not take mifepristone. Do not take mifepristone if it has been more than 49 days since your last menstrual period or if you have:

an ectopic pregnancy
an intrauterine device (IUD) in place (It must be removed before you take mifepristone)
problems with your adrenal glands (the glands near your kidneys)
been treated with certain steroid medications for a long period of time
bleeding problems or are taking anticoagulant (blood thinning) drug products
had an allergic reaction to mifepristone, misoprostol or similar drugs
It is important that you understand the need for 2 follow-up visits with your health care provider and that you have access to a medical care facility in case of an emergency.

Mifepristone has not been studied in women who are heavy smokers. Please tell your doctor if you smoke more than 10 cigarettes a day.

For more information please visit:  Mifeprex


February 26, 2010 - Posted by | 1

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