After 600 Incidents and Third Death, Stronger Warning for RU-486

WASHINGTON — After about 600 reports of infections and excessive bleeding and the deaths of three American women — including one this summer — the Food and Drug Administration decided to strengthen the warning label on RU-486, the pill that terminates early pregnancies.

But there is no indication the agency will pull the drug from the market.

“We are concerned about any drug that is related to serious medical complications and death,” said Dr. Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, during a Nov. 16 news conference. “We are sympathetic to those concerns.”

But, Galson said, “As you know, infections, bleeding and death may result from medical, surgical abortions and other kinds of obstetric interventions and childbirth. We feel the safety profile of this drug, along with the steps we're taking today, are adequate to allow the drug to be used safely. We will continue to monitor it.”

The FDA received a report about the latest death in August, in which a 22-year-old woman, who was seven weeks pregnant, went to the hospital with signs of an infection after taking the so-called abortion pill, which is also known as mifepris-tone and sold in the United States as Mifeprex, Galson said.

He added that the FDA did not bow to political pressure from the Bush administration, which has tried to ban partial-birth abortions. “This was a science-based decision,” he said.

But politics have entered the picture because Republican lawmakers are set to re-introduce a bill that would temporarily suspend the sale of RU-486, while also starting an investigation into its approval during President Bill Clinton's administration.

“This harmful and unethical drug was processed with a minimal amount of testing and short-circuited through the approval process due to political motivations,” said Dr. Pia de Solenni, director of life and women's issues with the Family Research Council, in a statement.

Though Galson insisted the FDA has not found any evidence to link the three deaths to the drug, the deaths have caused the agency some concern, resulting in the revised warning labels, he said.

But that concern is not enough for Monty Patterson, the father of Holly Patterson, the 18-year-old California woman who was the second American woman to die, in September 2003, after taking RU-486. He wants the drug banned.

“We feel there's more work that needs to be done,” he said. “We feel the drug has problems. We feel the FDA has not addressed all of our concerns.”

Since the controversial drug was approved in the United States in 2000, about 360,000 women have used it to end a pregnancy — despite it carrying the FDA's strongest safety alert, a “black box” label. Patients are also given a consumer medication guide.

Specific Warnings

Under the new labeling, patients are told to take the revised guides with them if they visit an emergency room or go to a doctor other than the one who prescribed the drug, so the health-care provider knows the patient is undergoing an abortion.

According to the FDA, the strengthened warning label adds new information on the risk of serious bacterial infections, sepsis, bleeding and death that may occur after any termination of pregnancy, including use of RU-486

The revised information also reminds health-care providers that sepsis, a severe illness caused by overwhelming infection of the bloodstream by toxin-producing bacteria, and bacterial infection may occur without the usual signs of infection, such as fever and tenderness on examination.

The new warning also says doctors should be on the lookout for patients with undiagnosed ectopic, or tubal, pregnancies because this condition may be missed by a physical examination and ultrasound. And, while some symptoms of an ectopic pregnancy may mimic the expected symptoms of a medical termination of pregnancy, RU-486 is not supposed to be used for the termination of these pregnancies, according to the FDA.

The first American woman who died after taking the drug — a 38-year-old who was four weeks pregnant — refused to go to the emergency room in October 2001 after complaining of bad cramping, Galson said. She had an undiag-nosed ectopic pregnancy, he said.

Holly Patterson, the California teen, died after sepsis developed.

‘Slap in the Face’

The revised labels are not enough for pro-life organizations, which seek a ban of the drug.

“It is an oxymoron to call RU-486 both ‘safe and effective,’” said Brian Johnston, executive director of the California Pro-Life Council. “It is specifically designed to be a lethal agent. Because it kills the child growing in the womb, we know that it is, for the most part, effective in its goal.

“By authorizing this ‘deadly medicine,’ the FDA should not be surprised when a drug like this is more than effective and kills the mother as well,” he said.

Cathy Cleaver Ruse, director of planning and information for the U.S. bishops' Secretariat for Pro-Life Activities, viewed the new warnings as “a slap in the face to women” and wondered how many more women have to die before the drug is taken off the market.

“Is three not enough?” she said. Meanwhile, the drug's American manufacturer, Danco Laboratories, reacted with less alarm to the new warning labels.

Updating labels is “standard procedure for all drugs,” said Cynthia Summers, Danco's director of marketing and public affairs.

Regarding the latest death that the FDA mentioned to the media, Summers said it wasn't clear whether the woman took RU-486. According to an autopsy report, the woman allegedly took a cancer medication that can be the cause of a terminated pregnancy. “We do not have information confirming that the woman took Mifeprex,” she said. “We are continuing to try and find out more information about this situation and will share any new developments with the FDA.”

One of the nation's leading abortion-rights groups, NARAL Pro-Choice America, did not view the FDA's new labeling as a big deal, either.

“We don't think it's a particularly monumental or a particularly noteworthy announcement,” said David Seldin, a spokesman for the organization. “All prescription drugs have occasional adverse reactions, and the FDA and the drug manufacturers work together to provide appropriate information to doctors and patients. And I don't think that this is anything more than that. The record on mifepristone is one of great safety.”

Carlos Briceño writes from Seminole, Florida.