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New Abortion-Pill Deaths Investigated

4 who died linked to clinics that didn't follow FDA protocol

Jul 20, 2005 | San Francisco Chronicle

Federal officials announced Tuesday that they are investigating two more cases of California women who died after using the abortion pill RU-486 and warned emergency room doctors to be on the lookout for unusual infections among women who have taken the pill.

At least five women have died in the United States after taking the pill since it began selling in 2000, including 18-year-old Holly Patterson from the East Bay, who died in 2003 after initially being sent home from a Pleasanton hospital where she sought treatment for abdominal pain.

Four of the deaths occurred in California and resulted from bloodstream infections. The U.S. Food and Drug Administration said it suspects that those four were associated with a bacterium that lacks some of the usual signs and symptoms of infection, including a fever.

"We want to make sure that physicians and patients using these drugs are aware of the potential risks of overwhelming infections that may occur, albeit rarely, with the use of this product," said Dr. Steven Galson, chief of the agency's Center for Drug Evaluation and Research.

The agency also said the four deaths occurred among women who were treated at clinics that didn't follow FDA-approved instructions for the two- pill regimen. Although the FDA stressed that it could not prove that the "off- label" use was to blame, its new public health advisory warns doctors of the possible link to such use.

The fifth death followed a ruptured tubal pregnancy, a dangerous condition and type of pregnancy that the drug does not terminate.

Galson said the newly reported deaths "don't alter the risk-benefit assessment of this drug." Infections are rare among women who use the drug, he said, occurring in less than 1 in 100,000 patients, comparable to the rate of infections with surgical abortions.

"There are no alarm bells going off because of this rate," he said. "But we are watching very closely."

Agency officials declined to say exactly where in the state the two latest cases occurred.

The new advisory comes eight months after the FDA announced it was issuing its most strident alert for the drug a "black box" warning in the drug's package insert that includes specific language about the possibility of death from bacterial infections and septic shock.

The treatment, known by the brand name Mifeprex, terminates pregnancy up to 49 days after the beginning of the last menstrual cycle. It consists of two drugs: The first blocks a hormone required to sustain a pregnancy, while the second, administered two days later, terminates the pregnancy.

The FDA's instructions call for women to swallow both pills. But most abortion clinics, relying on clinical research conducted since the drug was approved, instead instruct that the second tablet be inserted into the vagina.

Doctors have identified a bacterium called Clostridium sordelli in two of the four deaths from infection and suspects it is the cause of the other two. The bacterium is a common germ not usually associated with illness. Galson said it is unclear what may have caused the bacteria to become deadly in these women.

The FDA warned health care providers to be on the lookout for bacterial infections in women who have used the abortion treatment. Symptoms might include nausea, vomiting or diarrhea, and weakness without fever or other signs of infection.

Monty Patterson, a Livermore contractor and the father of Holly Patterson, said he believes the treatment "predisposes women to serious infection and death because it impairs the immune system."

Patterson and his wife are suing the drug's manufacturer, Danco Laboratories of New York, accusing the company of withholding information about the risks associated with the use of the drug. He said he thinks the drug should be taken off the market.

"We've got four deaths from infections as a result of taking this drug," said Patterson, who emphasized that he doesn't take a stand in the abortion debate. "My first concern is for the health and safety of women. This drug is not safe. It killed my daughter, and it killed others."

But a spokeswoman for the drug's manufacturer in the United States defended the drug's record.

"There are close to 460,000 women who have used this drug very safely and effectively (in the United States). At this point we have no reason to believe this is not a safe drug," said Cynthia Summers, public affairs director for Danco Laboratories.

She said the company had agreed to changes to the drug's label that warn doctors about what signs and symptoms to look for in cases of unusual infections.


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