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US reports two more deaths after abortion pill By Lisa Richwine
Is this a "Big Pharma" issue?
I'm solidly pro reproductive rights and I'm happy that women won the right to access yet another way to manage/oversee thier fertility. Having said that, I'm also suspicous of pharmaceuticals companies and their track records.
Is big pharma working with health care providers with an eye towards public safety? Or are shortcuts being taken, through our bodies and agianst our best interests?
We need to ask these questions and make sure that our interests are being served always...to avoid asking questions plays right into the hands of anti choice activists who will most certainly seize on this as another example of why women need to be "protected" from themselves.
US reports two more deaths after abortion pill By Lisa Richwine
2 hours, 15 minutes ago
Two new deaths have been reported after women took the abortion pill known as RU-486 but officials do not know if the fatalities are connected to the drug, U.S. regulators said on Friday.
"At this time we are investigating all circumstances associated with these cases and are not able to confirm the causes of death," the Food and Drug Administration said in an advisory to the public.
Four previously reported deaths were linked to complications from a bacterial infection that developed after the women took the abortion pill, which is sold by privately held Danco Laboratories.
In the two new cases, it is unknown if the women had bacterial infections, and if so, whether they were infected with the same rare bacterium identified in the earlier deaths. The bacterium is called Clostridium sordelli.
RU-486, also known as Mifeprex or mifepristone, is approved for terminating a pregnancy of 49 days or less. Another drug, misoprostol, is given two days later to complete the abortion.
The RU-486 label warns about the possibility of serious or even fatal infections, which also can happen after surgical abortions. In its alert issued Friday, the FDA urged physicians to be aware of the possibility of infection following RU-486 and to consider giving antibiotics if symptoms appear.
The agency also cautioned against use of unapproved dosing regimens. The four earlier deaths occurred after women were given misoprostol vaginally, rather than orally. The approved regimen calls for oral administration of both drugs.
"The safety and effectiveness of other Mifeprex dosing regimens, including use of oral misoprostol tablets intravaginally, has not been established by the FDA," the agency said.
RU-486 was approved in September 2000 over the objections of abortion opponents, who fought for years to keep it out of the United States. Some have called for a halt to sales while risks are further investigated.
The FDA said it learned of the two new deaths from Danco. A Danco spokeswoman did not immediately respond to a request for comment.
Is big pharma working with health care providers with an eye towards public safety? Or are shortcuts being taken, through our bodies and agianst our best interests?
We need to ask these questions and make sure that our interests are being served always...to avoid asking questions plays right into the hands of anti choice activists who will most certainly seize on this as another example of why women need to be "protected" from themselves.
US reports two more deaths after abortion pill By Lisa Richwine
2 hours, 15 minutes ago
Two new deaths have been reported after women took the abortion pill known as RU-486 but officials do not know if the fatalities are connected to the drug, U.S. regulators said on Friday.
"At this time we are investigating all circumstances associated with these cases and are not able to confirm the causes of death," the Food and Drug Administration said in an advisory to the public.
Four previously reported deaths were linked to complications from a bacterial infection that developed after the women took the abortion pill, which is sold by privately held Danco Laboratories.
In the two new cases, it is unknown if the women had bacterial infections, and if so, whether they were infected with the same rare bacterium identified in the earlier deaths. The bacterium is called Clostridium sordelli.
RU-486, also known as Mifeprex or mifepristone, is approved for terminating a pregnancy of 49 days or less. Another drug, misoprostol, is given two days later to complete the abortion.
The RU-486 label warns about the possibility of serious or even fatal infections, which also can happen after surgical abortions. In its alert issued Friday, the FDA urged physicians to be aware of the possibility of infection following RU-486 and to consider giving antibiotics if symptoms appear.
The agency also cautioned against use of unapproved dosing regimens. The four earlier deaths occurred after women were given misoprostol vaginally, rather than orally. The approved regimen calls for oral administration of both drugs.
"The safety and effectiveness of other Mifeprex dosing regimens, including use of oral misoprostol tablets intravaginally, has not been established by the FDA," the agency said.
RU-486 was approved in September 2000 over the objections of abortion opponents, who fought for years to keep it out of the United States. Some have called for a halt to sales while risks are further investigated.
The FDA said it learned of the two new deaths from Danco. A Danco spokeswoman did not immediately respond to a request for comment.
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"The FDA previously has said the abortion pill remains safe enough to stay on the market. The rate of sepsis is about one in 100,000 uses, ******comparable to infection risks with surgical abortions and childbirth.******
At least seven U.S. women have died after taking the pill, sold since 2000. The other U.S. death associated with Mifeprex was the 2001 case of a ruptured ectopic, or tubal, pregnancy. The drug is not to be used in those cases, in which the fertilized egg implants outside the uterus.
In the California cases, all four women tested positive for Clostridium sordellii, a common but rarely fatal bacterium.
Federal health officials plan a May 11 workshop in Atlanta to discuss emerging cases of disease involving the germ, which also have included infections in patients who have received skin grafts."
Food and Drug Administration:
http://www.fda.gov
http://sfgate.com/cgi-bin/article.cgi?file=/n/a/2006/03/17/national/w131552S46.DTL
Sorry to be dense, but does that means they had a pre existing condition and the pill made it worse, or that the pill introduced it? what does it mean?
As previously provided in our July 19, 2005 Public Health Advisory, updated on November 4, 2005, the Agency is aware of four previous confirmed deaths from sepsis in the United States, from September 2003 to June 2005, in women following medical abortion with mifepristone (Mifeprex) and misoprostol. All four cases of fatal infection tested positive for Clostridium sordellii. All four cases involved the off-label dosing regimen consisting of 200 mg of oral Mifeprex followed by 800 mcg of intra-vaginally placed misoprostol. In addition, FDA tested drug from manufacturing lots of mifepristone and misoprostol and found no contamination with Clostridium sordellii.
***We do not know whether these new deaths were caused by sepsis or, if they were, if they were caused by infection with Clostridium sordellii. ***
However, FDA, in conjunction with the Centers for Disease Control and Prevention (CDC) and the National Institute of Allergy and Infectious Diseases (NIAID), is conducting a public workshop on May 11, 2006. This scientific workshop entitled, “Emerging Clostridial Disease,” at the CDC Conference Center, Atlanta, Georgia, is being conducted to discuss the scientific and medical circumstances associated with reports of morbidity and mortality associated with C. sordellii and C difficile infections. These reports include cases and clusters of C. sordellii toxic shock syndrome following treatment with mifepristone, C. sordellii sepsis associated with skin grafts, and rapidly fatal toxin-mediated cases of community-associated C. difficile infection. The primary goal of the workshop is to bring together scientific and public health experts to develop a draft research agenda leading to a better understanding of the virulence, pathogenesis, host factors, and non-antimicrobial risk factors contributing to those reports.