Ru 486

RU-486 is actually two drugs, mifepristone, used in combination with misoprostol, and must be taken under a physician's supervision.Essentially, mifepristone induces a miscarriage by blocking the hormone progesterone, which is necessary to maintain a pregnancy.In a doctor's office, the woman takes three 200-milligram tablets of mifepristone, and returns two days later for two 200-milligram tablets of misoprostol, which causes uterine contractions. She remains for four hours, under observation, to ensure against possible adverse side effects, such as excessive bleeding, nausea and cramping.

Health and Human Services Secretary Kathleen Sebelius' decision this week to overrule the Food and Drug Administration commissioner and refuse to authorize girls under age 17 to have over-the-counter access to the emergency contraceptive pill known as Plan B is exactly the kind of triumph of politics over science that one might expect of the last administration. But even under President George W. Bush, there was a grudging acknowledgment that the "morning-after" pill ought to be available to women without a prescription.

Constancy of purpose has not been a strength of the Clinton presidency. But the administration deserves great credit for the patient and persistent negotiations that led to the announcement this week of an agreement to make the French pill RU-486 available in this country. RU-486 has become known as the "abortion pill" because it can end a pregnancy within seven weeks of conception without a surgical procedure.Roussel Uclaf, the French firm that makes the drug, has shown no interest in marketing the drug in the U.S., largely because of threat from abortion opponents to boycott the firm's other products.

WASHINGTON -- Republican legislators urged federal regulators to halt sales of RU-486 yesterday during a congressional hearing designed to draw attention to five deaths linked to use of the abortion pill and a companion drug. "There is a serious problem with RU-486, and failing to address this problem by disguising it, ignoring it, minimizing it or causing confusion is a shameful failure," said Rep. Mark E. Souder, an Indiana Republican. Souder, chairman of the drug policy subcommittee that held the hearing, and Rep. Jean Schmidt, a Republican from Ohio, criticized the Food and Drug Administration for refusing to withdraw RU-486 despite the deaths and other side effects.

WASHINGTON -- Food and Drug Administration officials defended the agency yesterday against charges that import restrictions on the abortion-inducing drug RU-486 are a response to political pressures by anti-abortion activists, saying the FDA stands ready to approve import of the controversial French drug for legitimate medical research.FDA representatives appearing at a House small business subcommittee hearing denied charges that limits on the import of RU-486 were depriving U.S. medical researchers of access to the drug, which could be useful in fighting breast cancer and other diseases.

BOSTON -- Within hours of the announcement, the small line popped up on one of the talk shows that dance across the cable channels: "All Over But the Shouting." Is that it? Does the FDA approval of RU-486 signal a full victory, a smack down in the wrestling match over abortion? RU-486 had been stalled for so long that I had come to think of it as the flight number of a plane held hostage. And of course it had been held hostage ... to politics. For a dozen years, the political turbulence had kept this drug grounded.

IN THE U.S. debate over RU-486, only two positions hav been recognized: anti-abortion activists who contest its use and pro-choice advocates who claim that it will revolutionize the abortion procedure for women. There is a third position: Women need safe, legal abortions, but RU-486 is a problematic and often harmful abortion method.There are many misleading claims for RU-486. Most people think it is one drug when, in fact, it is two -- RU-486 plus prostaglandin (PG). Often, other drugs are added to alleviate the side effects of the first two, thus becoming a sort of "drug cocktail."

WASHINGTON -- Despite the Clinton administration's solicitous attitude toward RU-486, efforts to make the so-called abortion pill widely available have been stalled for months by the manufacturer's fears of a backlash from abortion foes.One of President Clinton's first acts was to move to lift the U.S. ban on the French-invented drug, which serves as a licensed alternative to surgical abortion in Britain, France and Sweden.He ordered Secretary of Health and Human Services Donna E. Shalala to begin proceedings to get RU-486 licensed and manufactured in this country as quickly as possible.

BOSTON -- It's been stuck on the tarmac for so long that by now RU-486 sounds like the flight number of a plane taken hostage. And that's not far from the truth. RU-486, otherwise known as mifepristone, is the drug developed back in the 1980s by a French doctor so women could choose a non-surgical abortion very privately and very early in pregnancy. In the past dozen years, 500,000 French women have used it safely and effectively. It's been distributed to 20 other countries ranging from the United Kingdom and Finland to Greece and Israel.

WASHINGTON -- The Food and Drug Administration has scheduled an unusual workshop May 11 to look into the deaths of four California women who had taken RU-486, the abortion pill. Scientists and public health experts will meet in Atlanta to develop a plan for investigating the causes of the four deaths and detecting any other cases, according to a Federal Register notice to be published today. The FDA, which has updated the warnings on RU-486 in response to the deaths, is convening the workshop with the Centers for Disease Control and Prevention, the notice said.

WASHINGTON -- Federal regulators studying whether the abortion pill RU-486 was responsible for the deaths of two women who took the drug ruled out one of the cases yesterday. The Food and Drug Administration did not indicate which of the deaths had been ruled out. Cindy Summers, a spokeswoman for RU-486 manufacturer Danco Laboratories, said it was a death that took place several weeks after the abortion. The FDA is continuing to investigate the cause of the other death, which came several days after RU-486 was administered.

WASHINGTON -- Two more women who took the abortion pill RU-486 have died, according to federal drug regulators who are investigating whether the same rare infection that caused four earlier deaths was responsible. In announcing the two additional cases yesterday, the Food and Drug Administration issued an alert urging doctors and patients to follow approved directions for the drug, which is used in combination with another medication, and to look for warning signs or symptoms warranting immediate attention, such as nausea, vomiting, diarrhea or abdominal pain.

WASHINGTON -- The Food and Drug Administration has scheduled an unusual workshop May 11 to look into the deaths of four California women who had taken RU-486, the abortion pill. Scientists and public health experts will meet in Atlanta to develop a plan for investigating the causes of the four deaths and detecting any other cases, according to a Federal Register notice to be published today. The FDA, which has updated the warnings on RU-486 in response to the deaths, is convening the workshop with the Centers for Disease Control and Prevention, the notice said.

WASHINGTON -- Government investigators studying the deaths of four California women who took the RU-486 abortion pill played down the risks to other users yesterday and said the fatal infection that caused the deaths wasn't particular to women taking the drug. In an article in the New England Journal of Medicine, the investigators described the risk of the Clostridium sordellii infection as "low" and said it could occur after a woman has taken the pill, undergone a surgical abortion or given birth.

LIVERMORE, Calif. -- The rare bacterium that caused the massive infection that killed 18-year-old Holly Patterson of Livermore in 2003 has been linked to all four California women who died after taking the RU-486 abortion pill. The recent finding has led the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention to plan a scientific meeting to discuss what many view as a medical mystery, FDA spokeswoman Julie Zawisza confirmed. "We will further explore the issues and outstanding questions we don't have answers to right now," she said.

THE 1950s are back. Except instead of dying from hemorrhaging or infection after illegal abortions, women are dying from hemorrhaging or infection after legal ones. A California teen-ager died last month after self-administering the self-administered abortion pill RU-486, making her the seventh American casualty and third American death related to usage of the pill since its much-celebrated approval by the FDA three years ago. Holly Patterson was a 30-second story on the 11 o'clock news Sept.

Somewhere, in this country or overseas, there is supposed to be a villain who can be blamed for creating the almost unsolvable legal puzzle over use of the next "miracle" drug: RU-486. But everyone who might be the culprit is pointing at someone else.RU-486 -- a drug invented in France a decade ago -- is now proclaimed by many doctors, researchers, scientists and victims some kinds of cancer as a "medical breakthrough," a truly revolutionary new medicine. Depending upon what future tests show, RU-486 might even be useful in dealing with the AIDS epidemic.

This is the year, its proponents hope, that the French abortion drug RU-486 will be approved for the American market.Within weeks, they plan to send the results of clinical trials -- the experiences of 2,100 women from 17 clinics around the nation -- to the Food and Drug Administration, where Commissioner David A. Kessler has promised a "thorough and prompt review."Approval could come within a year of the application.Approving RU-486 for prescription would mean that women could end their pregnancies at home instead of in clinics.

BOSTON -- Within hours of the announcement, the small line popped up on one of the talk shows that dance across the cable channels: "All Over But the Shouting." Is that it? Does the FDA approval of RU-486 signal a full victory, a smack down in the wrestling match over abortion? RU-486 had been stalled for so long that I had come to think of it as the flight number of a plane held hostage. And of course it had been held hostage ... to politics. For a dozen years, the political turbulence had kept this drug grounded.