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FDA resists calls to pull abortion pill off market

Defends warnings added after 3d death

WASHINGTON -- The government said yesterday 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 teenager 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 is the case for 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 Sept. 17, 2003, of septic shock caused by inflammation of the uterus. The teenager 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.

The 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 whose pregnancies are suspected or confirmed to be categorized as tubal.

An additional 72 women bled so heavily after using the abortion pill that they required blood transfusions, and seven women suffered serious bacterial infections, including sepsis.

Antiabortion activists seized on Holly Patterson's death in their campaign to remove Danco Laboratories' product, Mifeprex, from the market.

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