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Two women die after using abortion pill
(AP)
Updated: 2006-03-18 09:11
Two more women have died after using the abortion pill RU-486, regulators
said Friday in a warning that brought renewed calls for pulling the
controversial drug from the market.
The organization that provided the pill to the two women said it would
immediately stop disregarding the approved instructions for the pill's use.
A nurse shows RU486
pills at a family planning clinic. Australia's parliament voted to strip
the conservative government of its right to veto women's access to the
controversial abortion pill RU486. [AP] |
The Food and Drug Administration warned doctors to watch for a rare but
deadly infection previously implicated in four deaths of women who had taken the
drug. The drug, also called Mifeprex or mifepristone, has not been proved to be
the cause in any of those cases.
Nor has the FDA confirmed the cause of the latest two deaths. However, in one
of them, the woman's symptoms appeared to resemble those in the cluster of four
cases in California where the women died from an infection of the bloodstream,
or sepsis. Those women did not follow FDA-approved instructions for the
pill-triggered abortion, which requires swallowing three tablets of one drug,
followed by two of another two days later.
Instead of swallowing the final two tablets, the second course of pills was
inserted vaginally in the four women, an "off-label" use that studies have shown
effective and that has been recommended by a majority of the nation's abortion
clinics. That use does not have federal approval though studies have indicated
it produces fewer side effects.
It was not immediately known if the second course of pills had been inserted
vaginally in the two latest women to die, an FDA spokeswoman said. She declined
to be identified, saying she was not authorized to speak publicly about the
issue.
Two Senate abortion foes, Republicans Jim DeMint of South Carolina and Tom
Coburn of Oklahoma, urged passage of legislation that would suspend sales of
RU-486 until the Government Accountability Office reviews how the FDA approved
the pill.
"RU-486 is a deadly drug that is killing pregnant women," DeMint said. "This
drug should never have been approved, and it must be suspended immediately."
Monty Patterson, a California man whose 18-year-old daughter, Holly, died in
2003 after taking the abortion pill, also said the drug should be pulled from
the market. The Senate bill is informally called "Holly's Law."
"The bottom line is that this is not about the abortion debate. This is about
the safety, health and welfare of women," Patterson said.
Meanwhile, Planned Parenthood Federation of America Inc. said it would
immediately stop recommending vaginal insertion of the final course of pills.
Four of the women who died, including the latest two, received the pills at
Planned Parenthood-affiliated clinics, said Dr. Vanessa Cullins, the
organization's vice president for medical affairs. Planned Parenthood estimates
RU-486 has been used 560,000 times in the U.S. since it was approved.
RU-486 is sold by Danco Laboratories and is approved to terminate pregnancy
up to 49 days after the beginning of the latest menstrual cycle. It blocks a
hormone required to sustain a pregnancy. When followed two days later by another
medicine, misoprostol, to induce contractions, the pregnancy is terminated.
Danco said it was reviewing information about the cases as it becomes
available.
The FDA previously has said the abortion pill remains safe enough to stay on
the market. The rate of sepsis is about one in 100,000 uses, comparable to
infection risks with surgical abortions and childbirth.
At least seven U.S. women have died after taking the pill, sold since 2000.
The other U.S. death associated with Mifeprex was the 2001 case of a ruptured
ectopic, or tubal, pregnancy. The drug is not to be used in those cases, in
which the fertilized egg implants outside the uterus.
In the California cases, all four women tested positive for Clostridium
sordellii, a common but rarely fatal bacterium.
Federal health officials plan a May 11 workshop in Atlanta to discuss
emerging cases of disease involving the germ, which also have included
infections in patients who have received skin grafts.
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