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| |  FDA Approves Mifeprex (Mifepristone) To End Early Pregnancies NEW YORK, NY -- September 28, 2000 -- The Food and Drug Administration (FDA) approved Mifeprex™ (mifepristone), a safe and effective non-surgical method for ending early pregnancy. Mifeprex gives women an early option in pill form. Mifeprex is a medical breakthrough in the United States. Taken orally, the early option pill is non-invasive and, for most women, does not involve surgery or anesthesia. "It is an important day in women's health care. With FDA approval of Mifeprex, American women have a safe and effective early option for ending pregnancy," said Dr. Richard Hausknecht, Associate Clinical Professor of OB/GYN at Mt. Sinai School of Medicine and Medical Director of Danco Laboratories, LLC, the pharmaceutical company that brought Mifeprex to the United States. "We and our partners in the women's health community have worked long and hard for this day. I am excited and very proud to be part of this." Mifeprex blocks a hormone that is needed for pregnancy to continue. When followed by another medicine, misoprostol, Mifeprex ends the pregnancy. Mifeprex followed by misoprostol is approximately 92-95 percent effective for ending a pregnancy. Bleeding and cramping are a normal part of the process. Women may experience bleeding similar to or greater than a heavy period and can expect bleeding or spotting for an average of nine to16 days. In some cases, women may have severe bleeding and need to contact their doctor right away. Side effects that may occur include nausea, headache, vomiting and diarrhea. A pain reliever can be taken to alleviate discomfort. Mifeprex can be taken to end a pregnancy from the time a woman knows she is pregnant up to seven weeks after the beginning of her last menstrual period. A woman using this option makes three visits to a doctor's office or clinic over a two-week period. At the first visit, she receives a Medication Guide (which explains how the early option works), is counseled and takes three tablets, each containing 200 milligrams of Mifeprex. Two days later she returns and takes two tablets, each containing 200 micrograms of misoprostol. A follow up visit approximately 12 days later checks that the pregnancy has ended. A few women who take Mifeprex will need a surgical procedure to end the pregnancy or to stop heavy bleeding. Health care providers will communicate to their patients how they have planned to handle this possibility. Health care providers will also give their patients a telephone number to call if they have any questions, concerns or problems. "I think most women to whom I have given this treatment in a clinical trials setting found it very acceptable. It gave them more sense of control; they felt it was a more private approach to pregnancy termination," said Dr. Carolyn Westhoff, Professor of OB/GYN and Public Health at Columbia University. "One thing that is really important about Mifeprex is that it offers women the choice of an early approach to use. I think this is very valuable to women." More than 2,000 women participated in clinical studies in the United States. The results were published in The New England Journal of Medicine and the American Medical Association's Archives of Family Medicine. Government regulatory agencies in France, Great Britain and Sweden approved mifepristone nearly a decade ago. More than half a million women in Europe have chosen this safe and effective early option. It has now been approved in eighteen countries worldwide. Mifeprex is provided directly to doctors' offices or clinics and is not available through pharmacies. "As with any new reproductive health option, patient counseling and information is very important," said Dr. Richard Hausknecht. Mifeprex will be available to physicians in approximately 4 weeks. "FDA approval of the drug mifepristone is an historical moment, comparable to the arrival of the birth control pill forty years ago," said Gloria Feldt, President of Planned Parenthood Federation of America. "We are overjoyed that with today's announcement from the FDA, Planned Parenthood will soon be able to offer American women the same early option that has been available in Europe for a decade."
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