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Hi, this is my blog for all sorts of pro-life news, statistics, stories, and personal ventings. I am a wife and mother, as well as a nursing student. I I truly believe that abortion has failed women, and will continue to do so as long as it is legal.


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Tuesday, June 13, 2006

Makers of Abortion Pill send "Dr. Doctor" letter in 04. It's been 2 years and Planned Parenthood is STILL not following manufacturer guidelines.

Danco Lab. The makers of Mifeprex issued the following letter on November 15,2004 calling for a Black Box warning on it's product.

Danco Laboratories is providing you with information regarding Mifeprex® (mifepristone), indicated for non-surgical abortion in patients who are ≤ 49 days pregnant, dated from the first day of the last menstrual period (LMP). From September 2000, when Mifeprex* was approved in the United States for marketing, through September 2004, approximately 360,000 women have been treated with Mifeprex in the U.S. Whether you provide Mifeprex in your private practice, a womenÂ’s health clinic, or a hospital clinic setting, you should be aware of serious and sometimes fatal infections and bleeding that occur rarely following spontaneous (miscarriage), surgical and medical abortions, including following the use of Mifeprex, and childbirth. A high index of suspicion is needed for timely diagnosis and intervention in these patients. To communicate this new safety information, Danco Laboratories has updated the BOXED WARNING and WARNINGS sections of the Prescribing Information as well as the MEDICATION GUIDE and the PATIENT AGREEMENT. Additional information is provided on ectopic pregnancy, which is a contraindication for Mifeprex (see WARNINGS). Copies of the updated Prescribing Information, which includes the MEDICATION GUIDE and the PATIENT AGREEMENT, are enclosed, and it is important for you to read them carefully. A summary of
the updated warnings follows:
Infection and Sepsis In postmarketing experience following the use of Mifeprex and misoprostol, we have received a few reports of cases of serious bacterial infection, including very rare cases of fatal septic shock (see WARNINGS). No causal relationship between these events and the use of Mifeprex and misoprostol has been established. Although infection following medical abortion is rare, we ask that you be alert to the possibility of infection in your patients. In particular, a sustained fever of 100.4 degrees Fahrenheit or higher, severe abdominal pain, or pelvic tenderness in the days after taking Mifeprex and misoprostol may be an indication of infection. Atypical presentations of serious infection and sepsis, without fever, severe abdominal pain, or pelvic tenderness, but with significant leukocytosis, tachycardia, or hemoconcentration can occur. {Additionalnal warnings concerning bleeding and ectopic pregnancies}

The MEDICATION GUIDE and PATIENT AGREEMENT have also been updated to reflect the new
safety information. Each patient should receive a MEDICATION GUIDE from her health care provider before taking Mifeprex. Please advise patients to take their MEDICATION GUIDE with them if they visit an emergency room or another health care provider who did not prescribe Mifeprex, so that provider will be aware that the patient is undergoing a medical abortion.Health Warning(PDF)


Again, this letter was written almost 2 years ago. So let's start from the beginning. The letter CLEARLY states that this option is only availablele to "patients who are ≤ 49 days pregnant, dated from the first day of the last menstrual period (LMP)". Funny that planned parenthood's Medical Abortion Q&A states "medication abortion works up to 56 days after the last period begins. Apparentlyly the warning hasn't phased our eager abortionists!

Planned Parenthood reiterateses 3 times that 56 days is the cut off for this type of abortion. They, even after the uproar surrounding their improper prescribingng techniques, continue to go againstst a BOX WARNING and administer this drug a full 7 days past the "safe" date. Perhaps 7 days seems a silly thing to bicker over, but when the total prescribingng time is 49 days, 7 represents a significant amount of time.

So I ask you, does planned parenthood REALLY care about women? My bet is they bank on those 7 day stragglers to require a surgical abortion and thus see them as extra income. How have they gotten away with this for 2 years?

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