SAN FRANCISCO (WOMENSENEWS)--Monty Patterson lost his daughter Holly just a few weeks after her 18th birthday last September. Holly had taken RU-486, an abortion drug that has been used by more than 1 million women worldwide and is widely viewed as a safe alternative to surgical abortion.
But Holly died tragically of a massive infection after taking the drug protocol.
"It was a really horrible death for her," Patterson said. He was with his daughter when she died, having only just learned about the pregnancy. "She had retained placenta and had an incomplete abortion. She could not overcome it."
Holly was a blond young woman who finished high school in three years. She was seven weeks pregnant last September when she and her boyfriend visited a Planned Parenthood near San Francisco to terminate the pregnancy.
At the clinic, she was given RU-486, also called mifepristone, the first of two drugs in the medical abortion protocol approved by the Food and Drug Administration in 2000.
Mifepristone, which blocks progesterone, the hormone needed to carry a pregnancy to term, has been used by about 350,000 women nationwide, according to Danco Laboratories, the drug's U.S. manufacturer and distributor.
On Tuesday, the Food and Drug Administration changed mifepristone's black box warning label to add new information about the risk of serious bacterial infection, sepsis, bleeding and death. The new information is meant to remind health care providers that serious bacterial infection may occur without the usual signs of infection such as fever and tenderness. At least two other American women besides Holly Patterson who took the abortion pill have died, though the FDA has not definitively linked those two deaths to the drug.
Planned Parenthood officials said in a statement that they support the new warning label because it is ``based on the best scientific information available.â€
Twenty-four hours after taking mifepristone, Holly followed Planned Parenthood's instructions to take a second drug, misoprostol, vaginally at home. Misoprostol induces uterine contractions.
Soon she experienced bleeding and pain. She went to the emergency room of a local hospital four days after the initial visit to Planned Parenthood. There, she was given painkillers and sent home.
Three days later, in the early morning hours of Sept. 17, Holly was admitted to the hospital. She died that afternoon, the same day she was scheduled to return to Planned Parenthood to make sure the abortion had been completed.
The cause of death was septic shock resulting from inflammation of the uterus from a drug-induced abortion, according to the coroner and a state investigation. Both Planned Parenthood and the local hospital were criticized for Holly's care, though experts said that it is extremely rare for such an infection to overwhelm the body so quickly. Patterson did not file a lawsuit against Planned Parenthood or the local hospital.
Medical Abortion Safe
Dr. Vanessa Cullins, vice president of medical affairs for the Planned Parenthood Federation of America, said Holly's death is a tragedy but that medical abortion is safe.
"Death is such a rare event associated with medical abortion that it's startling," Cullins said. "But this is a way for the anti-choice extremists to push the agenda of banning all abortions."
Holly's father, who lives in Livermore, Calif., a bucolic suburb east of San Francisco, says he is not taking sides in the political debate and is not out to change anyone's mind about abortion.
"There's no hidden agenda here," Patterson said. "We loved Holly dearly and we miss her every day. If everyone agrees that women's safety and welfare is important then maybe we can change things."
However, he believes the FDA's voluntary system of reporting adverse events harms women because patients and doctors don't have the whole picture of risks associated with drugs. A state investigation found that Holly's death wasn't reported to the FDA by either the hospital where she died or by Planned Parenthood.
"Holly suffered in silence," Patterson said. "I want to make sure no other women go through the same experience."
Earlier this fall, Patterson flew to Washington, D.C., and met with top FDA officials to press his case for mandatory reporting of adverse drug events and a ban on the two medical abortion drugs. He also met with the president's special assistant for domestic policy and his special assistant for legislative affairs.
Reviewing Post-Market Safety
A spokesperson for the FDA said the agency would not comment on the meetings. But recent high-profile cases of adverse drug reactions--such as findings that pain reliever Vioxx increases the risk of heart attacks--is causing the FDA to review how it manages post-market safety data.
While in Washington, Patterson spoke to 600 members of Concerned Women for America, an anti-choice group that filed a Freedom of Information Act request with the FDA for all adverse effects related to medical abortion. According to Danco Labs, more than 400 adverse events have been reported to the agency.
Patterson and Concerned Women for America also are seeking an investigation into so-called "off-label" regimens. Medical abortion is typically administered differently from the protocol approved by the FDA. Under the FDA protocol, the second drug is administered at the doctor's office orally. Most women, like Holly, take the drug vaginally at home at a different dosage.
"Abortion clinics are violating the restrictions on these drugs," said Wendy Wright, senior policy director for Concerned Women for America. Dr. Ruth Shaber, director of women's health services at Kaiser Permanente Northern California, said the "off-label" protocol is more effective than that approved by the FDA. "Volumes of research follow to show there's a better way of doing things as medicine evolves," Shaber said.
Cullins of Planned Parenthood said the group's actions are "politically motivated."
"Reporting around mifepristone is more stringent than most medications because of the political controversy," she said.
Patterson believes the medical abortion protocol requires women to play their own doctor at home, relying on a fractured health care network of day clinic and emergency room.
"Suddenly ER technicians are supposed to be experts on medical abortion," he said. "There's some really serious problems with the support care network."
Shaber agrees that the health-care system for women receiving an abortion is fractured, but more acceptance of abortion is needed to change that.
Patterson supports "Holly's law," a bill introduced by Rep. Jim DeMint, a Republican from South Carolina, and Sen. Sam Brownback, a Republican from Kansas, shortly after Holly's death. The law would suspend FDA approval of RU-486, pending an audit by the General Accounting Office. The bill is making its way through the approval process and has dozens of co-sponsors.
Rebecca Vesely is a health care reporter at the Oakland Tribune.
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