"How many more deaths is it going to take before the FDA takes action to remove this drug from the market?" said Monty Patterson, 51, of Livermore, Calif.
His 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 is unclear if their deaths were directly related to the pill's use.
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. He received a courtesy call Monday from the FDA alerting him to new warnings linking RU-486 to the risk of life-threatening bacterial infections. He didn't learn about the third death until reviewing the agency's Web site.
Anti-abortion activists seized upon Holly Patterson's death in their campaign against Danco Laboratories' product, Mifeprex.
An abortion rights activist said the abortion pill is "extremely safe and effective" when used correctly.
"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 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, adding information about such rare but potentially life-threatening complications as serious bacterial infections and bleeding that can follow any abortion, including one induced by Mifeprex.
Since the drug was approved, the agency has received reports of serious bacterial infection, bleeding, ectopic — tubal — pregnancies that have ruptured and death. The fatalities including a death from sepsis, a severe infection, recently reported to FDA and leading to the revised black box.
Serious bacterial infection may happen silently, without typical signs of infection like fever or tenderness, the label warns. The revised label also cautions health care providers that prolonged, heavy bleeding may warrant surgical intervention.
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 any health care provider they visit to speed 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. In a letter sent to health care professionals on Nov. 12, the company stood by the safety and efficacy of the drug.