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In the Spotlight

October 26, 2000

Ready Or Not RU-486 Is Here


By Lee Phillips, M.D.
PersonalMD.com Medical Advisory Board

The Food and Drug Administration approved RU-486, Mifepristone, which will be sold by prescription under the trade name Mifeprex for ending early pregnancies, the first 49 days, without undergoing surgery. Because the pill does not involve surgery it can be given in a physician's office.

RU-486 blocks the hormone progesterone that is needed for the egg to adhere to the uterus and for early pregnancies to continue normally. Mifepristone with another medicine called misoprostol, a prostaglandin that causes uterine contractions and leads to expulsion of the fertilized egg from the uterus.

Under the approved treatment regimen, a woman first takes 600 milligrams of mifepristone (three pills) by mouth. Two days later, she takes 400 micrograms, two pills of misoprostol. A woman must then return for a follow-up visit 14 days later to determine whether the pregnancy has ended. When used within the first seven weeks of pregnancy these medicines are 92-95.5 percent effective in causing abortion.

Because it is so very important to follow this treatment, each woman receiving RU-486 will be given a Medication Guide that clearly explains how to take the drug, who should avoid taking it, and what side effects can occur.

Most women using RU-486 will experience only slight side effects, primarily cramping and bleeding. Bleeding and spotting typically last for between 9 and 16 days. In about one of 100 women, bleeding can be heavy requiring surgical to stop the bleeding.

RU-486 is prescribed only by doctors who can accurately determine the date of a pregnancy and who can detect an ectopic (or tubal) pregnancy. Physicians who prescribe mifepristone must also be able to provide surgery in cases of severe bleeding or have some other plans made in advance.

Mifepristone, which was developed by a French pharmaceutical firm, was first approved for use in France in 1988. Since then, more than 620,000 European women have taken mifepristone in combination with a prostaglandin to end pregnancy. The drug has also been approved in the United Kingdom, Sweden, and other countries. RU-486, may one day be also a treatment for other diseases like fibroid tumors, ovarian cancer, endometriosis, and breast cancer.


  

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