Thursday May 18, 2006
FDA Defends Response to Deadly RU-486 Abortion Drug
By Gudrun Schultz
WASHINGTON, D.C., May 18, 2006 (LifeSiteNews.com) – The U.S. Food and Drug Administration said it responded “aggressively” to multiple reports of deaths linked to the chemical abortion drug RU-486, despite allowing the drug to remain on the market.
Four women in the U.S. alone died from infections with the rare bacterium Clostridium sordellii after taking the abortion drug, also known as Mifeprex or misoprostol, and a fifth recent death was also linked to the drug’s usage, involving a similar bacterial infection.
“FDA responded aggressively to these reports,” FDA Deputy Commissioner Janet Woodcock told a U.S. House of Representatives Government Reform subcommittee hearing, reported Reuters Wednesday. “What we don’t know is whether or not medical abortion increases the probability of getting this infection.”
Following the death of the fifth woman from bacterial infection after using the drug, the FDA released a public notice saying a link was “not known.”
“We do not know whether using Mifeprex or misoprostol caused these deaths. FDA has tested batches of Mifeprex and misoprostol and has not found any contamination with the type of bacteria involved in the four cases,” the statement read.
Research by Professor Ralph P. Miech in the Department of Molecular Pharmacology, Physiology and biotechnology at Brown University found the drug acted to suppress the body’s immune system, leaving it vulnerable to deadly infections from normally benign bacterium, reported LifeSiteNews in July of 2005.
Writing in the research journal, The Annals of Pharmacotherapy, Dr. Miech said RU-486 “impairs the body’s ability to fight off C. sordellii and may help spread the bacteria’s toxic by-products, a combination that sometimes results in widespread septic shock.”
In response to the growing concern over the drug, the FDA called a conference earlier this month to address scientific questions about the bacterium responsible in the deaths of the women. An FDA official told the Wall Street Journal Online that the workshop agenda did not include the possibility of taking regulatory action against the drug.
See related LifeSiteNews coverage:
Abortion Pill Deaths to be Investigated by US Food and Drug Administration
http://www.lifesite.net/ldn/2005/nov/05112303.html
FDA Conference on RU-486 Deaths to Examine Bacterial Connection
http://www.lifesite.net/ldn/2006/may/06050907.html
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