FDA approaches nal approval of abortion drug

By the end of 1999, the abortion-drug mifepristone, also known as RU-486, will be available to the public, after final approval from the Food and Drug Administration

But before the FDA can finally approve the drug "additional information on other issues including manufacturing practices and labeling, must be submitted before a final approval decision can be made," according to an FDA written statement.

Despite the FDA's anticipated approval of the drug, the University Health Service will not be dispensing RU-486.

"We do not have the technical support to handle the completion of it," said Robert Winfield, interim Director of University Health Service.

RU-486 is the common name for the drug mifepristone which is used together with misoprostol- normally used to treat ulcers. These two drugs together cause the uterus to contract and cause effects similar to a miscarriage. One- tenth of patients who take RU-486 require blood transfusions after miscarrying.

The drug is already available in France, Sweden and the United Kingdom. FDA clinical data shows the drug's benefits outweigh its risks.

UHS tries to "give people choices but (we) do not perform abortions. Our goal is to help them decide what they want to do through options counseling," Winfield said.

Winfield said 80 percent of women report cramping and bleeding following abortions. Most pain can be managed by drugs like Tylenol, he said.

If taken before the seventh week of pregnancy, the pill has 95 percent success rate, Winfield said. But the odds of a complete abortion decreases to 80 percent if taken between the seventh and ninth week of pregnancy.

Women who take the pill between this time frame may need minor surgery to complete the abortion and may experience increased side effects. No research has been done on the effects of the pill if used after nine weeks.

"It will be much easier for a woman to get an abortion. The RU-486 will be used as a form of birth control," LSA junior Jessica Laginess said.

The Planned Parenthood clinic in Ann Arbor performs both surgical abortions and medical abortions. They do not use RU-486, but for the past six months have been using the drugs methotrexate with misoprostol.

The misoprostol causes the uterus to contract which is similar to RU-486. It has been used since the 1960s in chemotherapy, but in this case it is used in much smaller dosages to perform a non-surgical abortion.

Director of Patient Services at Planned Parenthood Jill Michele said the drug carries similar side affects to RU-486. The success rate for these drugs are 95 to 97 percent.

When asked on the possible usage of RU-486 at the clinic, Michele said "I don't know. It depends on who is making it and how much it costs. We will be excited when the drug is available."

09-28-99