UCSF Expert Defends Use of Abortion Drug

by Nancy Chan The deaths of two women who had reportedly used mifepristone (originally known as RU-486) to terminate their pregnancies have renewed questions about the drug's safety. Philip Darney, MD, chief of Obstetrics, Gynecology and Reproductive Sciences at UCSF-affiliated San Francisco General Hospital, responds to questions about the drug's risks and benefits in the following interview. It seems that whenever there is a fatality attributed to use of mifepristone, there is almost an alarmist reaction by news media as to the safety of medical abortion. Is this reaction justified? Whenever there is any unusual circumstance surrounding a drug we administer - like that for mifepristone - we review the situation. After review of the most recent cases and of the two deaths (one was ultimately not attributed to the drug or the medical abortion process), we decided not to change the protocol of how we administer the drug. We did, however, change the way we inform women who choose medical abortion about the risks. And, in fact, the attributable risk is very small because, overall, these deaths in medical abortion are one in 100,000. This is compared to early surgical abortion, which is one to four in 1 million. Medical abortion is still safe and effective, and safer than childbirth. Can you explain how the drug works? If a woman is pregnant for nine weeks or less, and prefers medical rather than surgical termination, she is eligible for medical abortion. The patient takes the mifepristone orally in our clinic. What the drug does is block the action of progesterone, a hormone that maintains early pregnancy. A second drug, misoprostol, is administered vaginally on a different day to complete the process. The two drugs together combine to terminate the pregnancy. After a week she returns, and we make sure the abortion is complete. Are there are any side effects? With medical abortion, there is usually vaginal bleeding and uterine cramping. Nausea and queasiness are common side effects. Such side effects usually last longer than with surgical abortion, but there are some women who prefer not to have a surgical procedure. Since 2000, when the FDA approved use of mifepristone in the United States, there have been five known deaths (one in Canada) reportedly due to a bacterial infection that led to septic shock. Can you explain what the infection is? Clostridium sordelli is an organism that is also rarely reported with spontaneous abortions and pregnancy. This organism lives where there is not much oxygen. Blood encourages bacterial growth that in turn produces toxins that can be rapidly fatal. What is deceptive is that the patient feels relatively well and has few traditional symptoms, such as a high temperature or abdominal pain. The patients generally complain of symptoms such as nausea, vomiting and malaise. It's actually quite rare, but does occur. Are medical abortions the preferred method? Here at San Francisco General Hospital, it's actually a very low incidence, only about 5 percent of total cases. This is in contrast to 70 percent in Edinburgh, Scotland, 40 percent in France, and even in Planned Parenthood clinics, where around one-third of patients opt for medical abortion. Even in China, medical abortions are on the upswing and very common, and there have been no related deaths. Overall, the relative risk is low, but there is a wide variation of what patients choose to have performed. And the safety factor? We were one of the first clinics to do medical abortions 15 years ago, in a clinical trial using a different approach, so we count ourselves as one of the leaders. This method has proven to be safe and effective, and a safe alternative to surgical abortion.