F.D.A. Strengthens Warning on the Abortion Pill
WASHINGTON, Nov. 15 - The death of a California woman in January after she took an abortion pill prompted federal drug regulators on Monday to strengthen the warning label on the drug, RU-486, also known as mifepristone.
The death was the third in the United States that the Food and Drug Administration has linked to the pill since its approval in 2000.
The warnings, though largely present on the old labeling, will now be given added prominence, with physicians urged to redouble efforts at watching their patients carefully for signs of systemic bacterial infection, excessive vaginal bleeding and ectopic, or tubal, pregnancies.
Opponents of abortion say the latest death demonstrates that mifepristone is unsafe and should be withdrawn from the market. Abortion rights advocates, on the other hand, say that it has been used by nearly 360,000 women in the United States and that bad outcomes with it are exceptionally rare.
In the case of the latest death, though, the argument does not end there. Dr. Cynthia Summers, spokeswoman for mifepristone's American maker, Danco Laboratories, said she did not believe the fatality should be attributed to the drug, since the coroner's report said the woman had instead taken methotrexate, a cancer medication that has also been used to induce abortions.
"We believe our drug is not to blame," Dr. Summers said.
Dr. Lester Crawford, acting commissioner of food and drugs, disagreed. "Our investigation reveals that it was due to mifepristone," Dr. Crawford said. The F.D.A. would not elaborate.
Anti-abortion politics played no role in the agency's decision, Dr. Crawford said. "We received no political direction or counseling whatsoever" from the White House, he said.
The California woman died after a bacterial infection in her uterus had spread to her blood, leading to sepsis, or blood poisoning, Dr. Crawford said.
Neither he nor Dr. Summers would disclose any further information about the case, but the latest death is similar to that of Holly Patterson, a woman from the San Francisco area, who died of sepsis after taking mifepristone on Sept. 17, 2003, less than a month after her 18th birthday.
Ms. Patterson's father, Monty Patterson, became an outspoken critic of the pill. He said Monday that he was glad the F.D.A. had acted, adding, "Holly did not die in vain.''
Still, the agency's actions are not enough, Mr. Patterson said.
"I'm not convinced this drug is safe,'' he said, "and I still think it should be banned.''
As a result of Ms. Patterson's death, the agency had already been considering changes to mifepristone's label when, in August, officials there learned of the latest death, after Danco forwarded a copy of the coroner's report. Danco is required to forward any such reports to the F.D.A., and Dr. Summers said it had done so after someone sent it to the company even though another drug was listed as the cause of death.
Among abortion opponents calling Monday for mifepristone's removal from the market was National Right to Life. "I think the evidence is mounting that this drug is unsafe," said Dr. Randall O'Bannon, the group's director of education and research.
Wendy Wright, senior policy director of Concerned Women for America, a conservative women's group that has petitioned the F.D.A. to withdraw the drug, said the agency's action was insufficient.
"How many more women have to die before F.D.A. will put women's health and lives above the politics of abortion?" Ms. Wright said.
But Elizabeth Cavendish, interim president of Naral Pro-Choice America, said news of the latest death and the label change "are not monumental." Ms. Cavendish said, "These updates are really rather routine."
Dr. Paul Blumenthal, associate professor of obstetrics and gynecology at Johns Hopkins University School of Medicine and an adviser to Planned Parenthood, said taking mifepristone was safer than taking a pregnancy to full term.
Mifepristone is sold through physicians, who dispense the drugs directly to patients. Physicians are required to give patients a medication guide, which lists risks and tells them what to expect.
The guide will now be changed to instruct patients to call a health care provider right away if they have a fever, abdominal pain or heavy bleeding. It will also tell patients to take the guide with them if they go to a hospital emergency room.
Changes on the drug's physician prescribing label will say that while no causal relationship between mifepristone and bacterial infections or ectopic pregnancies has been established, physicians should be aware of the risks.
Danco will send letters highlighting the label changes to all its physician customers as well as to emergency room doctors around the country. The company sent letters in 2002 warning of the risks of infection.
The first woman in the United States whose death was tied to mifepristone suffered a ruptured ectopic pregnancy in September 2001. The F.D.A. has received 676 reports of problems with the drug, including 17 ectopic pregnancies, 72 cases of blood loss so severe that they required transfusions and 7 cases of serious infections, the agency reported.
GARDINER HARRIS
NY Times
The death was the third in the United States that the Food and Drug Administration has linked to the pill since its approval in 2000.
The warnings, though largely present on the old labeling, will now be given added prominence, with physicians urged to redouble efforts at watching their patients carefully for signs of systemic bacterial infection, excessive vaginal bleeding and ectopic, or tubal, pregnancies.
Opponents of abortion say the latest death demonstrates that mifepristone is unsafe and should be withdrawn from the market. Abortion rights advocates, on the other hand, say that it has been used by nearly 360,000 women in the United States and that bad outcomes with it are exceptionally rare.
In the case of the latest death, though, the argument does not end there. Dr. Cynthia Summers, spokeswoman for mifepristone's American maker, Danco Laboratories, said she did not believe the fatality should be attributed to the drug, since the coroner's report said the woman had instead taken methotrexate, a cancer medication that has also been used to induce abortions.
"We believe our drug is not to blame," Dr. Summers said.
Dr. Lester Crawford, acting commissioner of food and drugs, disagreed. "Our investigation reveals that it was due to mifepristone," Dr. Crawford said. The F.D.A. would not elaborate.
Anti-abortion politics played no role in the agency's decision, Dr. Crawford said. "We received no political direction or counseling whatsoever" from the White House, he said.
The California woman died after a bacterial infection in her uterus had spread to her blood, leading to sepsis, or blood poisoning, Dr. Crawford said.
Neither he nor Dr. Summers would disclose any further information about the case, but the latest death is similar to that of Holly Patterson, a woman from the San Francisco area, who died of sepsis after taking mifepristone on Sept. 17, 2003, less than a month after her 18th birthday.
Ms. Patterson's father, Monty Patterson, became an outspoken critic of the pill. He said Monday that he was glad the F.D.A. had acted, adding, "Holly did not die in vain.''
Still, the agency's actions are not enough, Mr. Patterson said.
"I'm not convinced this drug is safe,'' he said, "and I still think it should be banned.''
As a result of Ms. Patterson's death, the agency had already been considering changes to mifepristone's label when, in August, officials there learned of the latest death, after Danco forwarded a copy of the coroner's report. Danco is required to forward any such reports to the F.D.A., and Dr. Summers said it had done so after someone sent it to the company even though another drug was listed as the cause of death.
Among abortion opponents calling Monday for mifepristone's removal from the market was National Right to Life. "I think the evidence is mounting that this drug is unsafe," said Dr. Randall O'Bannon, the group's director of education and research.
Wendy Wright, senior policy director of Concerned Women for America, a conservative women's group that has petitioned the F.D.A. to withdraw the drug, said the agency's action was insufficient.
"How many more women have to die before F.D.A. will put women's health and lives above the politics of abortion?" Ms. Wright said.
But Elizabeth Cavendish, interim president of Naral Pro-Choice America, said news of the latest death and the label change "are not monumental." Ms. Cavendish said, "These updates are really rather routine."
Dr. Paul Blumenthal, associate professor of obstetrics and gynecology at Johns Hopkins University School of Medicine and an adviser to Planned Parenthood, said taking mifepristone was safer than taking a pregnancy to full term.
Mifepristone is sold through physicians, who dispense the drugs directly to patients. Physicians are required to give patients a medication guide, which lists risks and tells them what to expect.
The guide will now be changed to instruct patients to call a health care provider right away if they have a fever, abdominal pain or heavy bleeding. It will also tell patients to take the guide with them if they go to a hospital emergency room.
Changes on the drug's physician prescribing label will say that while no causal relationship between mifepristone and bacterial infections or ectopic pregnancies has been established, physicians should be aware of the risks.
Danco will send letters highlighting the label changes to all its physician customers as well as to emergency room doctors around the country. The company sent letters in 2002 warning of the risks of infection.
The first woman in the United States whose death was tied to mifepristone suffered a ruptured ectopic pregnancy in September 2001. The F.D.A. has received 676 reports of problems with the drug, including 17 ectopic pregnancies, 72 cases of blood loss so severe that they required transfusions and 7 cases of serious infections, the agency reported.
GARDINER HARRIS
NY Times
posted by R7 | 11/16/2004 10:45:00 AM
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