NEW YORK, Sep 28 (Reuters Health) - After 4 years of controversy and negotiation, the US Food and Drug Administration (FDA) on Thursday approved the abortion drug mifepristone, more commonly known as RU-486. The approval comes with some, but not all, of the prescribing restrictions originally discussed as conditions for getting the drug onto the market.

Mifepristone, which will be sold under the trade name Mifeprex, will be available to doctors within about 4 weeks, according to Danco Laboratories, the New York City-based pharmaceutical company that will distribute and market the drug.

The procedure for obtaining mifepristone is more burdensome than for other drugs, but the FDA's requirements surrounding the abortion drug are far less restrictive than they might have been.

As recently as June, it appeared that prescribing of the drug might have been limited to doctors who were trained to perform surgical abortions, had facilities to monitor patients using ultrasound, and were located within an hour of emergency facilities.

Dr. Carole Joffe, a professor at the University of California-Davis who studies abortion policy in the US, called the fact that the FDA will allow d

Mifepristone, which is taken orally, is approved for use for up to 7 weeks after the beginning of a woman's last menstrual period and can be prescribed as soon as pregnancy is confirmed. The drug works by blocking the hormone progesterone; without the hormone, the lining of the uterus breaks down and bleeding begins.

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The combination of mifepristone and misoprostol is 92% to 95% effective at ending pregnancy, according to Danco. Bleeding and cramping 'are a normal part of the process,' and some bleeding or spotting often continues for over 2 weeks, the company said. Side effects include nausea, headache, vomiting and diarrhea.

'Physicians when ordering need to be able to assess gestational age of the pregnancy, and diagnose ectopic (tubal) pregnancies,' Danco spokesperson Heather O'Neil told Reuters Health. 'And, in the few cases where Mifeprex doesn't work to end the pregnancy, physicians need to either provide surgical procedures themselves or refer the patient to someone who does.'

A Danco spokesperson stressed that information about which doctors have ordered the drug 'will never be made available

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