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RU486 Lawyer
Did you know?
About 560,000 women have taken RU486 since its approval in September 2000.
US Food and Drug Administration reported that two more women in the US have died after taking the abortion pill RU486. With this the number of fatalities has increases from five to seven, related with the drug since the drug was approved for use in 2000. RU-486, also known as Mifepristone, Mifeprex or the "abortion pill," is a drug given during early pregnancy to terminate the pregnancy without the need for a conventional suction abortion. The drug can be administered up to forty-nine days after the last period begins. RU-486 has been a controversial abortion drug due to moral stand points as well as the dangerous side effects and complications linked to it. Three women that took RU-486 experienced bleeding caused by rupture of ectopic pregnancies that led to the death of one of the women. Two other women suffered serious bacterial infections following the RU-486 with one of the women dying. The sixth woman who had used RU-486 suffered a heart attack despite her young age
The Quick Facts on RU486 (Mifepristone, Mifeprex)
· The FDA approved RU-486 in September 2000 on a fast track despite the dangers displayed by the drug.
· The abortion pill such as RU486, also known as Mifeprex or mifepristone, is approved for terminating a pregnancy of 49 days or less.
· Over 800 complications due to RU-486 have been reported to the FDA.
· The FDA admits that only 10 percent of complications suffered by patients from drugs get reported.
· In April 2002, the RU-486 maker sent a letter informing doctors of six women that have developed serious illnesses, as well as two reported deaths of women taking RU-486 to induce abortions.
· RU486 has been used in more than 500,000 abortions in the US since it became available in 2000.
· The RU486 label warns about the possibility of serious or even fatal infections, which can also happen after surgical abortions.
· The FDA urged physicians to be aware of the possibility of infection following RU486 use and to consider giving antibiotics if symptoms appear.
· RU486 was first approved in France over ten years ago, is distributed in the United States by Danco Laboratories. Some abortion opponents have questioned the safety of RU-486, particularly its relatively rare propensity to cause severe bleeding.
RU486 (Mifepristone, Mifeprex) F DA Warning
The FDA is not sure that RU486 (Mifepristone, Mifeprex) is the cause behind their deaths but is continuing an investigation. The FDA said in an advisory to the public, "At this time we are investigating all circumstances associated with these cases and are not able to confirm the causes of death." A FDA spokeswoman said that one of the women died several days after taking the abortion pill, the other death happened weeks after the pill was given.
In four previously reported fatalities of California women were linked to complications from Clostridium sordellii, a bacterial infection that developed after the women took the abortion pill. This is a common but rarely fatal bacterium in which the victim dies of a form of blood poisoning caused by this bacterium.
However, the FDA in its alert issued on Friday, Marcj 17, 2006, urged physicians and patients to be aware of the possibility of infection following RU486 and to watch for symptoms such as abdominal pain, nausea, vomiting, diarrhea and weakness with or without fever. The agency said that the doctors should consider immediate antibiotic treatment if they suspect an infection they also prescribe the blood tests to identify infections in patients without symptoms.
The FDA has planned a meet of the Centers for Disease Control and Prevention and the National Institutes of Health, in May, for scientists and public health experts to discuss infections with Clostridium bacteria.
At least seven US women have died after taking the pill, sold since 2000. The Food and Drug Administration cannot prove the drug was to blame in any of the cases.
In November 2004, Danco Laboratories and FDA notified healthcare professionals of revisions to the BOXED WARNING and WARNINGS sections, the MEDICATION GUIDE and PATIENT AGREEMENT of the Prescribing Information to describe serious and sometimes fatal infections and bleeding that may occur following the use of Mifeprex.
In July 2005, Danco Laboratories and FDA revised the BOXED WARNING and WARNINGS sections of the Prescribing Information, the Medication Guide and Patient Agreement to inform healthcare professionals of four cases of septic deaths in the United States , all reported from California , from September 2003 to June 2005 in women following medical abortion with mifepristone (Mifeprex) and misoprostol. The bacteria causing sepsis has been identified in two of the cases as Clostridium sordellii. The two confirmed cases of Clostridium sordellii did not have the usual signs and symptoms of an infection.
Drugs with fewer reported complications than RU486 that the FDA has pulled include:
NeutroSpec, an imaging agent used to diagnose internal infections, was pulled from the market after being linked to two deaths, 20 severe reactions, and 46 other "less" severe reactions.
Tysabri, a drug to treat multiple sclerosis, was pulled from the market on Feb. 28, 2005, after reports that three patients taking it had developed PML, a rare brain disease. Studies published in New England Journal of Medicine in early March reported no additional cases of PML.
Lotronex, the only drug in its class to treat irritable bowel syndrome (IBS), which afflicts approximately 40 million Americans was pulled. About 300,000 people had taken it. About 70 patients had developed severe problems, with five deaths including three possibly linked to the drug.
Bextra was pulled even though an FDA advisory committee voted a few months before that Bextra should remain on the market.
Concerned Women of America
Concerned Women for America (CWA) expressed outrage that the Food and Drug Administration (FDA) still refuses to pull the abortion pill RU-486 from the market even after announcing that two more women who took the drug have died. "The FDA has pulled other drugs that have caused fewer deaths and less severe complications than RU-486. Why the double-standard for an abortion drug that is now linked to the deaths of seven healthy women and over 800 other reported complications?" stated Wendy Wright, president of CWA.
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