FDA Warns Doctors of Abortion Drug Risks After Deaths Revealed

National   |   Steven Ertelt   |   Jul 20, 2005   |   9:00AM   |   WASHINGTON, DC

FDA Warns Doctors of Abortion Drug Risks After Deaths Revealed Email this article
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by Steven Ertelt
LifeNews.com Editor
July 20, 2005

Washington, DC (LifeNews.com) — The FDA on Tuesday sent a letter to doctors warning them of the dangerous associated with the abortion drug RU 486, marketed as Mifeprex. The agency told physicians to be aware of possible dangers of infections associated with the drug that could lead to death and have already killed five women since the drug was approved.

Four of the deaths, all of women in California, were caused by sepsis, an infection in the bloodstream, leading the agency to highlight the risks "when undergoing medical abortion using Mifeprex and misoprostol."

The FDA is advising doctors to prescribe antibiotics to women taking the abortion drug if they show any signs of infections. However, the agency warned that some women may not show ant telltale signs.

David Stevens, M.D., director of the Christian Medical Association, says the warning to doctors is not enough.

"With every death of another woman due to RU-486, the FDA’s mandate grows clearer–to pull this drug for an objective safety review," he said.

Meanwhile, FDA drug chief Dr. Steven Galson said he wasn’t sure if the abortion drug was to blame for the women’s deaths.

"We don’t know that this off-label use has caused the deaths,” he told the Associated Press.

Though the FDA discounts the abortion drug as the cause of the deaths, the county coroner who examined the body of Holly Patterson, a teen who died in September 2003, says the drug caused the infection which killed her.

Frank Gentle, supervising coroner investigator who looked into Patterson’s death, said "septic shock, due to endomyometritis (inflammation) due to therapeutic, drug-induced abortion," caused Patterson’s death. Endomyometritis is an inflammation of the mucous membrane lining of the uterus.

In other words, "the abortion caused inflammation, which caused the shock, which caused her death," Gentle said.

The FDA said the risk of the infections especially occurs when the abortion drug is used "in a manner that is not consistent with the approved labeling."

Planned Parenthood, the nation’s largest abortion business and the facility that gave Patterson the abortion drug, has been accused of not following FDA protocols, including using wrong doses of the abortion drug and misusing the ulcer drug misoprostol to cause a miscarriage of the dead baby.

The abortion business also sometimes instructs women to insert the drug vaginally while FDA guidelines call for oral use.
Searle, the maker of the ulcer drug, issued a nationwide letter to doctors years ago saying it is not intended to produce an abortion and using it as such places women’s health at risk.

All four of the California deaths occurred in cases where the abortion drug was being used "off label" in an inconsistent manner with FDA protocols, Galson told AP.

Despite the misuse of the drug, Galson claims it is still safe enough for public use.

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

Danco Laboratories, the maker of the mifepristone abortion drug, announced Monday that it would change warning labels on the drug to note the infection risk.

As of November 2004, the FDA had received 676 reports of negative side effects, including 17 potentially fatal ectopic pregnancies, and seven women had serious infections like the one that led to the death of Holly Patterson.

Numerous women felt sick and dizzy enough to require hospitalization and another 72 women bled so severely after using the abortion drug that they required transfusions.