RU-486 Headed to Clinics and Doctors' Offices
Nov. 21, 2000 -- The long and turbulent road for abortion pill RU-486 hits another milestone. The distribution of the drug began Monday and is on schedule, according to Danco Laboratories of New York, the contracted distributor of the abortion pill. Doctors could receive their shipments as early as Tuesday.
"We've experienced no problems," a Danco spokeswoman, who asked not to be identified, tells WebMD.
RU-486, which is being sold under the brand name Mifeprex, is an early medical alternative to a surgical abortion. Women can take the prescription drug up to seven weeks after the start of their last menstrual period, provided they meet the guidelines.
The regimen calls for women to take several Mifeprex pills by mouth. Two days later, another drug called misoprostol is taken. Women visit their doctor's office or clinic at least three times in two weeks while they use the abortion pill.
Women typically bleed and experience cramping as part of the process. Other side effects include nausea, headache, vomiting, and diarrhea. One in 100 women taking the drug experience bleeding severe enough to need surgery.
The Danco representative says the company is filling orders to both private doctors' offices and community clinics, such as those operated by Planned Parenthood.
In February, the FDA announced it would approve the use of the abortion pill in the U.S. But at the time of the announcement, federal regulators said there still were details to be addressed. It would be another seven months until the approval came on Sept. 28.
But there were stipulations put on the FDA approval. Women taking the drug would be given a medication guide to tell them how to take it, who should not take it because of the risk of complications, and what side effects could happen.
Also, Mifeprex would be distributed to doctors who could determine how far along a patient was in her pregnancy, assuring she was still within the first seven weeks. A doctor also would have to be able to determine the woman did not have an ectopic pregnancy, where the fetus was developing outside the uterus in a fallopian tube. The doctor also would have to be able to provide or prearrange surgery if the abortion did not work or bleeding were too severe.
The Population Council, which was given the rights to make and distribute the drug in the U.S., also is going to continue to study the drug. One of the studies will look at the outcomes among women taking Mifeprex who ended up needing surgery, compared to women who had a surgical abortion to begin with.
Patients also are required to sign an agreement form before they begin to take Mifeprex, and future studies will determine if they're indeed being signed and made part of the patients' medical records. The Population Council also will develop ways of tracking the rare pregnancies that continue after a woman takes the abortion pill.
The Danco representative says that in addition to filling the orders for Mifeprex, the company also is sending the medication guides, prescribing information, order forms, brochures, and copies of recent studies.