FDA approves use of abortion pill RU-486

By LAURAN NEERGAARD

Associated Press

WASHINGTON – The Food and Drug Administration today approved U.S. use of the abortion pill RU-486, a major victory for those who battled for 12 years to bring the early-abortion method to this country.

Proponents say the pill, which has been used by millions of women in 13 countries, could transform abortion in the United States by making it more accessible and more private. But it can be used only in the earliest days of pregnancy.

It could be available to doctors within a month.

“For those who choose to have an early termination of their pregnancy, this is a reasonable medical alternative,” said FDA Commissioner Jane Henney.

Anti-abortion organizations have fought to keep RU-486 out of the United States since the drug debuted in France in 1988. They pledged to continue the fight.

“We will not tolerate the FDA’s decision to approve the destruction of innocent human persons through chemical abortion,” said Judie Brown of the anti-abortion American Life League.

Worried about anti-abortion violence that has sprung up in recent years, the FDA has increased security in some of its offices and, in an unusual move, Henney is keeping secret the names of the medical officers who reviewed the drug.

“The climate around the reproductive-rights issue and personal safety issues are in our minds,” she said.

To ensure the pill is used accurately and safely, the FDA mandated that women be given special brochures called “MedGuides” explaining who is eligible for a pill-caused abortion and what side effects to expect and that they must make three trips to the doctor for the procedure.

RU-486, now known by its chemical name mifepristone, can be used only within 49 days of the beginning of the woman’s last menstrual period. The woman takes three mifepristone pills. Two days later, she returns to the doctor to swallow a second drug, misoprostol, that causes uterine contractions to expel the embryo. She returns for a follow-up visit within two weeks to make sure the abortion is complete.

The FDA will allow mifepristone to be distributed only to doctors trained to accurately diagnose the duration of pregnancy and to detect ectopic, or tubal, pregnancies, because those women cannot receive mifepristone.

Also, the FDA restricted mifepristone’s use to doctors who can operate in case a surgical abortion is needed to finish the job or in cases of severe bleeding – or to doctors who have made advance arrangements for a surgeon to provide such care to their patients.

Studies show mifepristone is 92 percent to 95 percent effective in causing early abortion, by blocking action of a hormone essential for maintaining pregnancy. Without that hormone, progesterone, the uterine lining thins so an embryo cannot remain implanted and grow.

The pill-induced abortion can be painful, causing bleeding and nausea. Heavy bleeding is a potentially serious side effect but one the FDA determined is rare. In safety testing of the first 2,100 American women who took mifepristone, four bled enough to need a transfusion.

A small New York company, Danco Laboratories, will market mifepristone under the brand name Mifeprex. It should be available in about a month. Abortion providers say the pill-caused abortion should cost the same as surgical abortion, but a Danco spokeswoman refused to confirm that today.

The FDA’s decision, coming in the midst of the presidential election campaign, is sure to generate fierce new controversy. Republican candidate George W. Bush opposes abortion; his father’s administration banned RU-486 from this country in 1989. The pro-choice Clinton-Gore administration worked for seven years to bring mifepristone here.

Proponents argued that a pill-caused abortion offers a surgery alternative that feels more like a miscarriage and typically is offered earlier in pregnancy than surgical abortion.

Bowing to that pressure, French manufacturer Roussel-Uclaf in 1994 turned over U.S. rights to the drug to the nonprofit Population Council of New York, which launched U.S. clinical trials needed for FDA clearance. Although the FDA actually declared mifepristone a safe and effective abortion method in 1996, final approval was delayed until now because Danco, created to market the drug, had trouble meeting federal manufacturing and labeling requirements.

The vast majority of today’s 1.3 million annual U.S. abortions are surgical, although doctors in 1995 began publicizing the fact that a drug already sold to treat cancer, methotrexate, also could be used to induce abortion.

Health experts say mifepristone won’t increase abortions – that didn’t happen in Europe. But the FDA’s formal approval may encourage more doctors who don’t offer surgical abortions to offer the pill, thus making it easier for women, particularly in rural areas, to get an abortion without traveling hundreds of miles or entering surgical clinics often staked out by protesters.

The National Abortion Federation, which accredits abortion providers, said 240 of its member clinics were already prepared to offer Mifeprex, and it is training other physicians in how to use the pill.

Copyright ©2000 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

Talk to us

> Give us your news tips.

> Send us a letter to the editor.

> More Herald contact information.

More in Local News

Kim Skarda points at her home on a map on Thursday, June 20, 2024 in Concrete, Washington. A community called Sauk River Estates has a very steep slope above it. There is a DNR-approved timber sale that boarders the estate properties, yet they were not consulted about the sale before approval. The community has already appealed the sale and has hired their own geologist to conduct a slope stability report at the site. (Annie Barker / The Herald)
Beneath steep slope, Concrete neighbors fear landslides from logging above

Nielsen Brothers plans to cut 54 acres of timber directly behind the community of 83 homes. Locals said they were never consulted.

Law enforcement respond to a person hit by a train near the Port of Everett Mount Baker Terminal on Thursday, June 27, 2024 in Mukilteo, Washington. (Annie Barker / The Herald)
2 killed in waterfront train crashes were near Mukilteo ‘quiet zone’

In June, two people were hit by trains on separate days near Mukilteo Boulevard. “These situations are incredibly tragic,” Everett’s mayor said.

Rob Plotnikoff takes a measurement as a part of the county's State of Our Waters survey at Tambark Creek in Bothell, Washington on Monday, July 1, 2024. (Annie Barker / The Herald)
Snohomish County stream team bushwhacks a path to healthier waterways

This summer, the crew of three will survey 40 sites for the State of Our Waters program. It’s science in locals’ backyards.

Logo for news use featuring the municipality of Mountlake Terrace in Snohomish County, Washington. 220118
4th suspect arrested after Mountlake Terrace home robbery

Police arrested Taievion Rogers, 19, on Tuesday. Prosecutors charged his three alleged accomplices in April.

A 10 acre parcel off of Highway 99, between 240th and 242nd Street Southwest that the city of Edmonds is currently in the process of acquiring on Monday, July 10, 2023 in Edmonds, Washington. (Olivia Vanni / The Herald)
Edmonds ditches $37M Landmark public park project off Highway 99

The previous mayor envisioned parks and more in south Edmonds, in a historically neglected area. The new administration is battling budget woes.

Edmonds school official sworn in as Mount Vernon supe

Victor Vergara took his oath of office last week. He was assistant superintendent of equity and student success in Edmonds.

Everett
Everett courthouse garage briefly closed for ‘suspicious package’ report

A man drove his car into the Snohomish County Courthouse garage and reported he believed the package was in his car.

High-capacity magazines at The Freedom Shoppe gun store, which was holding a sale in anticipation of new gun control measures, in New Milford, Conn., April 2, 2013. The store is liquidating their stock of weapons expected to be banned. Months after the massacre of 26 people at a school in Newtown, Conn., legislative leaders in the state on Monday announced what they called the most far-reaching gun-legislation package in the country. (Wendy Carlson/The New York Times)
WA high court leaves ban in place for now on high-capacity ammo magazines

Monday’s decision will keep the law in effect until the court hears arguments, possibly this fall, on the bill sponsored by an Edmonds senator.

Firefighters respond to a 911 call Tuesday morning in Mill Creek. (Photo provided by South County Fire)
Mill Creek house fire displaces 3

Firefighters responded to a house fire in the 14100 block of 30th Avenue SE early Tuesday morning. No one was injured.

Alyvia Nguyen, 8, climbs on leaf shaped steps at the new Corcoran Memorial Park playground on Friday, July 12, 2024 in Bothell, Washington. (Olivia Vanni / The Herald)
New Bothell-area park ‘could not be a more fitting dedication’

In 2019, Jim Corcoran donated $1.5 million worth of land to become a public park. He died before he could see it completed.

Cars line up for the Edmonds ferry in Edmonds, Washington on Thursday, Dec. 7, 2023.  (Annie Barker / The Herald)
Ferry line jumpers face a $145 fine — and scorn from other drivers

Law enforcement is on the lookout for line cutters. It’s a “hot-button issue that can lead to something worse.”

Mother charged in Stanwood toddler’s fentanyl overdose death

Morgan Bassett woke up in January 2022 and found her daughter wasn’t breathing. Last week, she was charged with manslaughter.

Support local journalism

If you value local news, make a gift now to support the trusted journalism you get in The Daily Herald. Donations processed in this system are not tax deductible.