FDA Restrictions on RU 486 'Not Strong Enough'
July 7, 2008
(CNSNews.com) - Restrictions by the Food and Drug Administration in the distribution of the French abortion drug, RU-486 - which abortion rights groups have denounced as too restrictive - do not go far enough, pro-life groups say.
Because of the drug's dangerous side effects, the FDA now is requiring a national registry of all the doctors prescribing RU 486. Doctors who prescribe RU-486 also must have admitting privileges at a hospital within one hour of their office.
Since the administration of RU-486 is a complicated procedure that is usually carried out over a three-day period, the drug's prescription and administration should be restricted to doctors who are trained to perform surgical abortions, the FDA is suggesting.
Randall K O'Bannon, spokesman for the National Right to Life Committee, strongly opposes the introduction of the drug into the US, saying, "If the FDA had been faithful to its basic mission of guarding public health, it should have protected the unborn child and rejected RU-486 altogether."
The FDA's concern about the health of women taking RU-486 is not new, nor is it unjustified, O'Bannon said. "This is a dangerous drug." Not only does it destroy the life of an unborn child, it's also going to harm the women who take it, he said.
RU-486 currently is available to women in countries that boast variations of nationalized health care systems, such as France and Great Britain, and its distribution is done at limited locations under highly regulated conditions.
French doctors who administer RU-486 are required to have emergency resuscitative equipment and electro-cardiograph equipment nearby in case of complications, O'Bannon said. After the drug was first considered in the United States, even those who favored its use were aghast when they heard about the training program its sponsor was proposing.
"They had a lot of these concerns way back in the beginning about how this was going to work. Not only about training on how to administer the pill, but training to do back-up surgery if the drug failed or if they had complications," he said.
Administration of RU-486
The first stage of the procedure calls for the administration of misepristone, a drug that kills the child in the womb. This drug procedure is followed by another - the administration of misoprostol - that causes the baby to be expelled from the womb.
One of the problems associated with misoprostol is that some of the women who take it experience excessive bleeding.
Over a 12-month period beginning in September 1994, the drug's sponsors conducted a study in the US with 2,121 women ages 18 to 35 who were pregnant for periods of 63 days or less.
Researchers found the primary negative side effect of RU-486 was excessive bleeding, some of which necessitated blood transfusions and resulted in hospitalizations, including emergency room visits, surgical interventions and administrations of intravenous fluid.
Even though this was a small percentage of the 2,100 women who underwent the procedure, "it's not a very high percentage until you are the woman that's experiencing this," said Tina Whittington, a spokeswoman for Why Life?, the youth division of the American Life League.
After the woman is administered misoprostol, the doctor usually confines her to his or her office until she expels the baby, which usually takes four hours.
According to the FDA recommendation, doctors also should do follow-up studies of all the patients who were prescribed RU 486. Researchers in the US found that some women bled for up to 60 days after they took RU 486 and some developed endometritis, an inflammation of the lining of the uturus, after taking the drug.
Since there is an 8 percent failure rate of RU-486 to kill babies aged 49 days or less, the FDA ruled that doctors who administer the drug must be trained in providing surgical abortions. The farther along the woman is in her pregnancy, the greater the chances are that the drug will fail to kill the baby.
Whittington said she sees the potential for abuse, even if RU-486 is restricted for use among women who are pregnant for 49 days or less.
"Once it's in the hands of doctors, who knows whether they'll pay as close attention as they did to the women in the study. If the FDA truly wanted strong restrictions on this drug, they'd specify that it may not be prescribed for pregnancy over 49 days, or that it may not be prescribed to women with certain complications," Whittington said.
"The bottom line is, when you take RU 486, you're going to deliver a dead baby. Although these [FDA] restrictions are there, for pro-lifers they're not strong enough, either for women or for the babies," she said.