FDA Issues Warning About Abortion Drug

The Food and Drug Administration has issued a warning over the use of the abortion drug RU-486, or mifepristone, following the deaths of five women who used the drug. Mifepex (the brand name) has been available in the United States since 2000, more than 1 million women have taken it worldwide over the past decade and about 200,000 women in the U.S. have used it to end unwanted pregnancies without surgery.

Following four deaths from infection, the FDA has issued a warning, even though it admitted to not being able to tie the deaths directly to RU-486. Four of the deaths were attributed to a blood infection called sepsis, also known as toxic shock syndrome. The other death resulted from complications of a ruptured ectopic pregnancy after Mifeprex was used. The FDA specifically advises that the drug not be used in the case of extra-uterine pregnancy because of the danger of infection.

These deaths were caused by the women using the drug in a manner not approved by the FDA:

The 4 deaths caused by bloodstream infections, or sepsis, all occurred in women who didn’t follow FDA-approved instructions for a pill-triggered abortion, said agency drug chief Dr Steven Galson. “We don’t know that this off-label use has caused the deaths,” he cautioned.

The action comes just 8 months after the FDA warned about 2 sepsis cases associated with Mifeprex, also called RU-486 or mifepristone. Additional sepsis cases were reported to the agency in April and June 2005.

The drug, sold by Danco Laboratories, is approved to terminate pregnancy up to 49 days after the beginning of the last menstrual cycle. It blocks a hormone required to sustain a pregnancy. When followed by another medicine, misoprostol, the pregnancy is terminated.

The FDA’s instructions call for women to swallow both pills, but most abortion clinics instead instruct that the misoprostol tablet be inserted into the vagina, Galson said. Studies have shown it can work that way, too. But the 4 sepsis deaths, all reported from California, came after this so-called off-label use. Galson couldn’t say whether the women had inserted the tablet vaginally themselves. In 2 of the infections, doctors identified a bacterium called _Clostridium sordellii_, a common germ not usually associated with illness, he said.

Approved by the FDA over the protests of anti-abortion groups in September 2000, mifepristone is considered a safe and effective drug that offers women a nonsurgical option for pregnancy termination. Many women feel this option provides them greater privacy and autonomy. The FDA points out, however, that mifepristone, like any drug, carries a degree of risk, but suggests considering the risk in the context of the broader risk of maternal mortality.

Serious and sometimes fatal infections occur very rarely following miscarriage and surgical and medical abortions, and the risk of infection following medical abortion remains very low. A few statistics: In the USA, reports of all infections following Mifeprex are well below 1 per cent. To put the safety of medical abortion in perspective, there are about 13 pregnancy-related deaths per 100 000 live births, according to the CDC. Abortion, whether medical or surgical, is much safer than pregnancy and childbirth. Furthermore, it should be understood that the “off label” use of mifepristone itself does not present a risk to women who use the drug. Evidence-based regimens of mifepristone medical abortion are widely used in the USA and abroad, which reduce rather than increase a woman’s risk of serious side effects.

The challenge now for health care professionals, patient advocates, and health journalists will be to communicate accurate and clear information about these methods so women who are considering the option of abortion can make informed decisions.


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