FDA Criticized on Abortion Pill Safety

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FDA Criticized on Abortion Pill Safety

JoAnn Guest

Nov 16, 2004 12:10 PST

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Health - AP

FDA Criticized on Abortion Pill Safety

1 hour, 44 minutes ago Health - AP

 

 

By DIEDTRA HENDERSON, AP Science Writer

 

WASHINGTON - The government on Tuesday said a controversial abortion

pill is safe enough to remain on the market, despite a third death

and a grieving father's plea.

 

Monty Patterson, father of a teen who died after taking the abortion

pill RU-486 (news - web sites), says the government's new safety

warnings aren't enough to protect women. Because a third death now

has been linked to RU-486, the Food and Drug Administration (news -

web sites) should bar sales of the abortion pill, he said.

 

 

" How many more deaths is it going to take before the FDA (news - web

sites) takes action to remove this drug from the market? " said

Patterson, 51, of Livermore, Calif.

 

 

" We are concerned about any drug that is related to serious medical

complications and, certainly, death, " said Dr. Steven Galson, acting

director of the FDA's Center for Drug Evaluation and Research.

 

 

Still, infection, bleeding and death can accompany abortion, whether

accomplished by surgery or medication, as well as childbirth.

 

 

" We feel that the safety profile of this drug, along with the steps

that we're taking ... are adequate to allow the drug to be used

safely, " Galson said.

 

 

Patterson's 18-year-old daughter, Holly, died on Sept. 17, 2003, of

septic shock caused by inflammation of the uterus. The teen took RU-

486 on Sept. 10 to terminate an unplanned pregnancy, Patterson said.

 

 

At least two other American women who took the pill in the United

States died, although the FDA says it has not definitively tied any

death to use of the pill. The agency's decision to strengthen the

drug's " black box " warnings was triggered by the third death.

 

 

Those three deaths were among 676 adverse events reported through

Nov. 5 by women who used the abortion pill. The reports include

women who felt sick and dizzy to more serious illnesses that

required hospitalization, according to the FDA.

 

 

Seventeen women who used RU-486 had tubal pregnancies; the drug is

not to be used in women with suspected or confirmed ectopic

pregnancies. Another 72 women bled so heavily after using the

abortion pill that they required blood transfusions. And seven women

suffered serious bacterial infections, including sepsis.

 

 

After his daughter's death, Patterson began lobbying for changes to

avoid another tragedy.

 

 

Anti-abortion activists seized upon Holly Patterson's death in their

campaign to remove Danco Laboratories' product, Mifeprex, from the

market.

 

 

A company spokeswoman disputed their claims.

 

 

" The drug is safe. It's effective. And it provides another option

for women to end early pregnancy, " said Cynthia Summers, marketing

director at New York-based Danco Laboratories.

 

 

" All of us need to understand that no procedure, no medication is

risk free, " said Vanessa Cullins, vice president for medical affairs

at Planned Parenthood (news - web sites) Federation of America. The

federation uses the abortion pill at its clinics.

 

 

Galson said the agency's actions were not dictated by the Bush

administration.

 

 

" There was absolutely no political pressure, " he said. " This was a

science-based decision. "

 

 

 

 

 

The FDA approved Mifeprex in 2000 to terminate pregnancy up to 49

days after the beginning of the last menstrual cycle. The drug

blocks progesterone, a hormone required to sustain a pregnancy. When

followed by another medicine, misoprostol, Mifeprex terminates the

pregnancy.

 

Mifeprex already carries a " black box " warning, the agency's most

strident alert, to highlight other safety concerns. The FDA said

Monday that the drug's black box warning will expand.

 

Serious bacterial infection may happen silently, without typical

signs of infection like fever or tenderness, the label warns.

 

Women who have taken the drug should contact a doctor immediately if

they suffer fever, abdominal pain and heavy bleeding, a medication

guide aimed at consumers says. And the FDA counsels women to take

their medication guide to speed medical treatment.

 

In addition, women who take the pill must sign a patient agreement

pledging to contact a doctor immediately if they have fever higher

than 100.4 degrees that lasts more than four hours or severe

abdominal pain. The women are also warned that heavy bleeding that

soaks two, thick full-sized sanitary pads per hour for two

consecutive hours is cause for contacting a doctor.

 

According to Danco Laboratories, 360,000 American women have used

the pill since it was approved by the FDA.