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FDA strengthens RU 486 warning; not enough, pro-lifers say

WASHINGTON (BP)–The U.S. Food and Drug Administration has unveiled stronger warning labels for the abortion drug RU 486, but pro-life advocates and the father of a teenager who died after taking the pill said that action is insufficient.

The FDA announced Nov. 15 it is expanding the “boxed warning” for Mifeprex, the trade name for mifepristone, also known as RU 486. Mifeprex’s “boxed” label, which constitutes the highest level of warning on an FDA-approved drug, says “[s]erious and sometimes fatal infections and bleeding occur very rarely” after abortions, including those from the use of RU 486.

The federal agency also noted that a third woman had died after using the abortion drug. The most recent fatality, reported in August, involved a 22-year-old woman, whose name was undisclosed and who was seven weeks pregnant when she died of an apparent systemic infection, according to an agency spokesman.

Previously, two deaths following the use of the abortion drug had been reported. Last year, Holly Patterson, 18, died of a systemic infection in September after obtaining RU 486 from a Planned Parenthood clinic in Hayward, Calif. In October 2001, a 38-year-old woman, whose identity was undisclosed, died from a ruptured ectopic pregnancy.

Monty Patterson, Holly’s father, called for stronger action by the FDA.

“How many more deaths is it going to take before the FDA takes action to remove this drug from the market?” he told The New York Times, according to LifeNews.com. “I’m not convinced this drug is safe, and I still think it should be banned.”

Cathy Cleaver Ruse, a spokeswoman for the U.S. Conference of Catholic Bishops, said in a written release the drug “doesn’t need a better label; it needs to be shelved. RU 486 was the new ‘magic pill’ to make babies disappear, and young women are now its latest victims. RU 486 must be stopped.”

Wendy Wright, senior policy director of Concerned Women for America, said, “When women’s lives are at stake, this is unacceptable. While the label changes implicitly admit the dangerous nature of the drug, trusting abortionists to follow the warnings is a futile effort and does nothing to make the drug itself safe.

“Not only is the drug unsafe, but abortionists refuse to follow the FDA’s current guidelines -– even after Holly Patterson’s tragic death,” Wright said in a written statement. “Why would anyone think that by the FDA changing words on a label abortionists will suddenly put women’s health and lives above their own convenience and profits?”

RU 486 causes the lining of the uterus to release the embryonic child. RU 486 normally is used in the first seven weeks of pregnancy. A second drug, a prostaglandin, is taken two days after mifepristone and causes the uterus to contract, expelling the baby. When the FDA approved Mifeprex, it required the anti-ulcer drug misoprostol to be used to eject the pre-born baby. Cytotec is the trademark name for the drug mandated for expelling the baby in the RU 486 process.

Monty Patterson and his wife, Helen, who live in Livermore, Calif., endorsed legislation last November to suspend the FDA’s approval of the abortion drug. The RU 486 Suspension and Review Act, S. 1930 and H.R. 3453, would suspend approval of RU 486 pending a review of the FDA’s process in certifying the abortion drug for use in the United States. The legislation has not received a vote in Congress.

In October 2003, CWA, as well as the Christian Medical Association and the American Association of Pro-life Obstetricians and Gynecologists, filed a brief calling for the FDA to withdraw RU 486 from sale until a safety review is conducted. The same groups filed a petition in 2002 with the FDA urging immediate revocation of RU 486.

That petition is still being considered, and there is no timeline for a response, Center for Drug Evaluation and Research acting director Steven Galson told reporters during a conference call Nov. 16. The center is under the FDA umbrella.

There have been about 600 “adverse event reports” related to RU 486 since it was approved in 2000, Galson said. “We have not been able to link any of [the deaths] in terms of the drug causing the event,” he said.

In addition to the strengthened “boxed warning,” the medication guide for RU 486 also says users should contact a physician immediately for “fever, abdominal pain and heavy bleeding.” The “boxed” label warns doctors that “serious bacterial infections” can be present without fever and other symptoms.

Pro-life organizations, including the Southern Baptist Ethics & Religious Liberty Commission, fought introduction of RU 486 into this country for more than a decade before it was approved. The administration of President George H.W. Bush, in office from 1989-93, refused to allow importation of RU 486, which was known as the French abortion pill because of its development in France. On his second full day in office in January 1993, President Clinton initiated the process to drop the import ban on the drug, but it required nearly his entire eight years in office to gain FDA approval.