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Are abortion pill safety warnings enough?

The government said a controversial abortion pill is safe enough to remain on the market, despite a third death and a grieving father’s plea.
/ Source: The Associated Press

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, 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 should bar sales of the abortion pill, he said.

“How many more deaths is it going to take before the FDA 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.

Expanding 'black box' warning
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 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.