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Side
effects RU-486 raise health concerns
By
Nadia Abu-Hijleh
Online Forty-Niner
Contributing Writer
Although
the process takes a mere 10 minutes, it
is no wonder why surgical abortions leave
women in search of an easier alternative.
The slurping noise of the suction machine,
the hardhearted atmosphere in the tiny patient
room and the loneliness are all absolutely
terrifying.
The
abortion scene in America was altered when
the Food and Drug Administration concluded
in 2000 that mifepristone in its pill form
(RU-486) used in combination with misoprostol
is safe and effective for the termination
of early pregnancy, defined as 49 days or
less from the first day of the last menstrual
period.
In
November 2004, after four years on the market,
the Food and Drug Administration announced
important labeling changes for mifepristone.
Recent reports of serious bacterial infection,
bleeding, ectopic pregnancies that have
ruptured and death have led to the revision
of the drug's black box labeling to include
these risks.
The
approved prescribed amount includes administration
of 600 mg of mifepristone in an oral dose.
Two days later, the patient returns to her
doctor. If she is still pregnant, she takes
400 micrograms of misoprostol orally. She
is to return to her doctor for a third visit
to check the termination of her pregnancy.
While
abortion by prescription may seemingly make
it easier for a woman to end a pregnancy,
safety issues appear to have been compromised
for this less invasive procedure.
Holly Patterson, 17, of Livermore, Calif.
died on Sept. 17, 2003 of septic shock.
The teen had received an off-label prescription
of mifepristone and misoprostol on Sept.
10 to terminate an unplanned pregnancy.
A
large number of clinicians exercise their
legal right to adapt the approved protocol
and prescribe mifepristone and misoprostol
off-label. As indicated by Planned Parenthood's
Web site, a common adaptation of the abortion
pill regimen includes reducing the dosage
of mifepristone to 200 mg, eliminating the
second visit by allowing women to self-administer
a higher dose of misoprostol vaginally and
extending the time period for using mifepristone
to 63 days after the first day of the last
menstrual period.
Although
scientific evidence deems the adapted prescriptions
of mifepristone and misoprostol safe, Dr.
Ezra Levy, a health science professor at
Cal State Long Beach, argues that clinicians
are pushing this drug regimen into unsafe
territory.
Levy
explains that the abortion pill regimen
is very predictable as far as knowing that
mifepristone will cause sloughing off of
the uterine lining, creating an inhospitable
environment for the fetus, and misoprostol
will cause uterine contractions to expel
the fetus. Levy said, however, that everyone
has a unique biochemistry, making the side
effects and their level of severity individuals
will experience unknown.
"The
lay public is largely ignorant about the
mechanics of drugs … [Clinicians]
that are allowing patients to independently
take these medications for an aggressive
procedure are inviting the potential for
serious adverse effects to occur without
… recourse," Levy said.
"I
didn't even know what RU-486 (mifepristone)
was until Holly died," said Monty Patterson,
her father.
When
Holly visited the emergency room on Sept.
14, 2003 for heavy bleeding and severe cramps,
she was told her symptoms were normal and
was sent home with pain killers. She is
one of three American women who took the
pill and died. The FDA says it is unclear
if their deaths are related to the pill's
use.
Approximately
350,000 women have been treated with mifepristone
in the United States according to the FDA's
Web site. Through Nov. 5, 2004 the FDA has
received reports of 676 adverse events that
occurred among women who had taken mifepristone
to terminate pregnancy. Again, the FDA says
these events cannot with certainty be attributed
to mifepristone.
Despite
all adverse events, Planned Parenthood's
Web site says,'"An overwhelming majority
of women who choose mifepristone for medical
abortion are satisfied with the method.
One study found that 97 percent of women
would recommend the method to a friend.
Additionally, 91 percent of the women reported
that they would choose the mifepristone
regimen again if they had to have another
abortion."
"Let's
see … take a pill or have surgery?"
graphic design major Jen Harper asked herself.
With a snicker she said,""Yeah,
I'd rather take the [abortion] pill."
The question appeared to be a no-brainer
for most women.
"It's
a pill'… it seems easy," said
Deb Castro, a comparative literature major.
Without knowing the procedure or side effects,
female students assumed the pill would be
a less traumatic, less complicated experience.
Such
attitudes do not surprise Levy. "In
America, we have a pill for everything.
We're always looking for chemicals to solve
all our problems."
This
is not a symptomatic free drug regimen Levy
said. He notes that the procedure does not
spare the patient emotionally since the
woman is left to deal with the expelled
fetus on her own, which can happen at any
time after the first pill is consumed. Levy
also points out that taking the drug regimen
does not make the abortion a less painful
event, since the pill tends to bring on
intense cramping.
Women
need to understand that the abortion pill
is not as easy as it seems, Levy said; it's
not like using Tylenol to make a headache
go away.
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