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FDA Issues Warning On RU-486

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The US Food and Drug Administration issued a warning regarding the emergency contraception pill RU-486 after a rare infection took the life of a fourth California woman. The agency suspects that proper FDA protocols were not followed.

The deaths are currently under investigation by the FDA and emergency room doctors were admonished to be vigilant in looking for unusual infections among women who have taken the pill.

Overall five women have died in the US after taking the pill, approved for prescription use in 2000. The first to suffer a deadly infection was 18-year-old Holly Patterson of East Bay, California. Patterson died in 2003 after seeking treatment for abdominal pain.

The FDA believes the bloodstream infections were caused by a particular bacterium that is difficult to detect because they don’t carry the usual signs of infections like fevers.

“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 public health advisory issued by the FDA reiterates the need for doctors and patients to follow FDA-approved instructions that involve a two-pill regimen. The agency suspects the regimen was not followed in the cases that resulted in four of the deaths.

The fifth death was the result of a rare ruptured tubal pregnancy, which the RU-486 pill is not designed to terminate.

Galson said that infections among women who use the drug occur in less than 1 in 100,000 patients, a rate comparable to infections caused by surgical abortions.

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

The two-pill treatment, marketed under the brand name Mifeprex, terminates pregnancy up to 49 days after the beginning of the last menstrual cycle. The first pill blocks a hormone required to sustain pregnancy. The second, taken two days later, terminates the pregnancy.

FDA Issues Warning On RU-486
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