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Merck & Co. Inc. Message Board

  • rokdoc49 rokdoc49 Nov 19, 2004 11:15 AM Flag

    FDA Strengthens RU-486 Warning

    FDA Strengthens RU-486 Warning
    by Steve Jordahl, correspondent

    SUMMARY: The warning label on the abortion drug is
    changing as the result of problems predicted by pro-life
    activists.

    The Food and Drug Administration (FDA) is strengthening
    the warning label on the abortion pill RU-486 in the wake
    of three deaths associated with the medication.

    Pro-life advocates are pleased the label will now warn of
    the possibility of serious bacterial infections, bleeding
    and death -- yet they insist the drug shouldn't even be on
    the market.

    RU-486 already contains a "black box" warning, the
    government's strongest safety alert. The additions come
    because of the number of reported incidents tied to the
    drug, according to Dr. Steven Galson, the acting director
    of the FDA's Center for Drug Evaluation and Research.

    "We've received approximately 600 overall reports," Galson
    said. "The ones that we're focused on, though, for this
    labeling change, are the really serious ones, particularly
    the deaths. And there have been three deaths."

    Despite the numerous complications, though, Galson
    contended the drug is safe and that there was no political
    pressure to increase the warning.

    "We feel that the safety profile of this drug -- along
    with the steps that we're taking today -- is adequate to
    allow the drug to be used safely," he said.

    Dr. David Stevens of the Christian Medical Association
    disagreed.

    "This is a small step in the right direction, but not
    sufficient enough to deal with this issue," he said. "I
    don't think we're seeing anything but the tip of the
    iceberg with the complications that are going on. Those
    involved in the abortion industry are going to do
    everything they can to cover up what's going on.

    "This drug should be removed from the market; that's why
    we participated in a citizen's petition, asking the FDA to
    withdraw this drug."

    The FDA has yet to respond to that petition, filed two
    years ago. Carrie Gordon Earll, senior analyst for
    bioethics at Focus on the Family, said the time for action
    is long overdue.

    "The grave moral concerns with mifepristone aside, the
    Food and Drug Administration obviously knows there are
    problems with this drug," she said. "How many more women
    have to die or be injured by mifepristone before the FDA
    takes this serious and responds to the petition?"

 
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