Mifeprex (mifepristone) is a pill administered for a medical abortion up to 7 weeks after pregnancy, and is an alternative to surgical abortion. The drug blocks a hormone required to sustain a pregnancy, and when followed by Cytotec (misoprostol) to assist with contractions, the pregnancy is terminated. Since the U.S. FDA approved the drug in September 2000, more than 460,000 women have used the pill in the United States to end pregnancies. Mifeprex is manufactured by Danco Laboratories.
There have been 637 reported cases of adverse side effects associated with Mifeprex. Many of these cases involved side effects such as hemorrhage, infection, and deadly septic shock. There have been five reported deaths from septic shock after taking Mifeprex. All the deaths have been associated with a rare bacterial infection called Clostridium sordellii.
With pressure from the FDA and consumer groups, Danco added a black box warning to RU-486 package insert alerting doctors of the risk of serious and sometimes fatal infection. Medical professionals have identified that RU-486 may block the body's natural glucocorticoid mechanism to suppress inflammation. The drug then promotes unhealthy inflammation which can lead to septic shock and death.
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Symptoms of a Deadly Infection:
The FDA has issued an alert recommending that healthcare professionals be aware of atypical symptoms of infection in patients using the Abortion Pill. Symptoms include weakness, nausea, vomiting or diarrhea, abdominal pain and fever.
Physicians are now advised to immediately treat women suspected of having such an infection with antibiotics that include coverage of anaerobic bacteria such as Clostridium sordellii to ward off possible serious bloodstream infection. Such infection may lead to death, hysterectomy or other serious injury.
Heart-breaking Tragedy:
Eighteen-year-old Holly Patterson from the San Francisco Bay Area died in September 2003 after taking the Mifeprex drug for an abortion. After the treatment, she visited a local hospital for severe abdominal pain but was sent home. The victim's parents have filed a lawsuit against Danco Laboratories, the drug manufacturer, as well as The Population Council, which sponsored the drug through the FDA approval process. The lawsuit alleges that information about the risk of serious and fatal infection associated with the drug was withheld.
Mifeprex, RU-486 In the News
Doctors Voice Worry Over Abortion Pills' Safety. (Apr-01-06) [
NEW YORKS TIMES]
Two more women die after using the RU-486 Abortion Pill and the FDA plans a full investigation into the drug's side effects and risks. (Mar-17-06) [
FDA]
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MERCURY NEWS]
The FDA and the Centers for Disease Control announce that they will investigate the deaths of four California women in association with the Abortion Pill RU-486. (Nov-23-05)
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MERCURY NEWS]
Women's Deaths Prompt Abortion Pill Warning Label (Jul-20-05)
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WEB MD]
New Abortion Pill Deaths Investigated - 4 Who Died Linked to Clinics that didn't Follow FDA Protocol (Jul-20-05) [
SF GATE]
The FDA announces a warning label change to the Mifeprex, RU-486 Abortion Pill after reports of serious bacterial infection, bleeding, ectopic pregnancies that have ruptured, sepsis and death in patients who used RU-486.
(Nov-15-04) [
FDA]
If a loved one has died after taking Mifeprex, you may qualify for damages or remedies that may be awarded in a possible lawsuit. Please click on the link below to submit your case.
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