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

Customers enter and exit the Costco on Dec. 2, 2022, in Lake Stevens. (Olivia Vanni / The Herald)
Costco stores could be impacted by looming truck driver strike threat

Truck drivers who deliver groceries and produce to Costco warehouses… Continue reading

Two Washington State ferries pass along the route between Mukilteo and Clinton as scuba divers swim near the shore Sunday, Oct. 22, 2023, in Mukilteo, Washington. (Ryan Berry / The Herald)
Ferry system increases ridership by a half million in 2024

Edmonds-Kingston route remains second-busiest route in the system.

Firefighters respond to a 911 call on July 16, 2024, in Mill Creek. Firefighters from South County Fire, Tulalip Bay Fire Department and Camano Island Fire and Rescue left Wednesday to help fight the LA fires. (Photo provided by South County Fire)
Help is on the way: Snohomish County firefighters en route to LA fires

The Los Angeles wildfires have caused at least 180,000 evacuations. The crews expect to arrive Friday.

x
Edmonds police shooting investigation includes possibility of gang violence

The 18-year-old victim remains in critical condition as of Friday morning.

The Everett Wastewater Treatment Plant along the Snohomish River. Thursday, June 16, 2022 in Everett. (Olivia Vanni / The Herald)
Everett council approves water, sewer rate increases

The 43% rise in combined water and sewer rates will pay for large infrastructure projects.

Robin Cain with 50 of her marathon medals hanging on a display board she made with her father on Thursday, Jan. 2, 2025 in Lake Stevens, Washington. (Olivia Vanni / The Herald)
Running a marathon is hard. She ran one in every state.

Robin Cain, of Lake Stevens, is one of only a few thousand people to ever achieve the feat.

People line up to grab food at the Everett Recovery Cafe on Wednesday, Dec. 4, 2024 in Everett, Washington. (Olivia Vanni / The Herald)
Coffee, meals and compassion are free at the Everett Recovery Cafe

The free, membership-based day center offers free coffee and meals and more importantly, camaraderie and recovery support.

Devani Padron, left, Daisy Ramos perform during dance class at Mari's Place Monday afternoon in Everett on July 13, 2016. (Kevin Clark / The Herald)
Mari’s Place helps children build confidence and design a better future

The Everett-based nonprofit offers free and low-cost classes in art, music, theater and dance for children ages 5 to 14.

The Everett Wastewater Treatment Plant along the Snohomish River on Thursday, June 16, 2022 in Everett, Washington. (Olivia Vanni / The Herald)
Everett water, sewer rates could jump 43% by 2028

The rate hikes would pay for improvements to the city’s sewer infrastructure.

The bond funded new track and field at Northshore Middle School on Thursday, Oct. 24, 2024 in Bothell, Washington. (Courtesy of Northshore School District)
Northshore School District bond improvements underway

The $425 million bond is funding new track and field complexes, playgrounds and phase one of two school replacements.

Pharmacist Nisha Mathew prepares a Pfizer COVID booster shot for a patient at Bartell Drugs on Broadway on Saturday, Oct. 1, 2022, in Everett, Washington. (Ryan Berry / The Herald)
Everett lawmakers back universal health care bill, introduced in Olympia

Proponents say providing health care for all is a “fundamental human right.” Opponents worry about the cost of implementing it.

Outside of the updated section of Lake Stevens High School on Thursday, Feb. 27, 2020 in Lake Stevens, Wa. (Olivia Vanni / The Herald)
Lake Stevens, Arlington school measures on Feb. 11 ballot

A bond in Lake Stevens and a levy in Arlington would be used to build new schools.

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.