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What's up with RU 486?

Was RU 486 approved, and where is it available?

RU 486, the French abortion pill, is still making its way through an obstacle course into the US drug system - although it's now very close to approval. The Food and Drug Administration recently said it would allow sale of the drug, pending more information on how RU 486 will be labeled and manufactured. There will be certain rules to ensure its safety. For example, doctors who prescribe it must meet certain requirements, and women who take it must live within an hour of emergency treatment in case something goes wrong.

I'm happy to see this drug finally become available as an option for women who want abortions. Known chemically as mifepristone, it's vastly superior to the methods available now. Still, RU 486 should not be taken lightly. It requires three steps. First, the woman takes 600 milligrams of RU 486 to end the pregnancy. It's 95.5 percent effective when used within the first seven weeks. Then, she must take another drug to induce contractions in the uterus to expel the fetus. Finally, she must go back in for an exam to make sure the pregnancy has been aborted.

Using this drug is much less traumatic than undergoing surgery. The side effects are similar to a spontaneous miscarriage: bleeding, cramps, nausea, and fatigue. Serious complications are rare. In clinical trials in the United States, 4 out of 2,100 women needed a blood transfusion because of uncontrolled bleeding.

Women began using RU 486 in France in 1988. Protests by anti-abortion groups were so venomous, however, that manufacturer Roussel-Uclaf suspended distribution. Almost immediately, the French Minister of Health stepped forward and ordered the company to sell the drug in the interest of public health. I've heard that about 200,000 women have used the drug in Europe - it's approved in France, the United Kingdom, and Sweden. In the United States, the Bush administration was not so open-minded. It banned the import of RU 486. Clinton lifted the prohibition in 1993, and Roussel-Uclaf gave the rights for the drug to a nonprofit research institution in New York, the Population Council, which began clinical trials here to test safety and effectiveness.

An FDA advisory committee recommended approval for RU 486 in July - then the FDA announced in September that it was ready to approve the drug, which will probably be renamed in the United States.

The clinical trials have been completed, but people won't have access to the drug until the FDA finalizes approval, expected early this year. Meanwhile, you can keep up with RU 486's progress by checking the Web sites run by the National Abortion and Reproductive Rights Action League Foundation and the Planned Parenthood Foundation. While surfing around for an update, watch out for disinformation. There's plenty of it on unmarked sites that look like they're intended to help women with unwanted pregnancies, but actually are run by anti-abortion groups and use all sorts of fear-mongering techniques.

 

 
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