On July 19, 2005, the Food and Drug Administration (FDA) issued a Public Health Advisory warning of the potential risks of using RU-486 for early pregnancy termination. The drug mifepristone, sold under the trade name Mifeprex in the U.S., has been linked to the recent deaths of four California women. Since all of the women died of septic shock following a Mifeprex regimen, the FDA urged medical providers to suspect this condition in patients taking the drug.
On November 4, an update to the FDA's warning stated that the four septic shock victims were found to have the same type of bacterial infection. This finding lends further support to the Mifeprex-septic shock connection.
What is RU-486?
RU-486, also known as “the abortion pill”, is an artificial steroid that blocks progesterone, a hormone needed to carry a pregnancy to term. Previously used in France, RU-486 was introduced to the United States in 2000, when the Food and Drug Administration (FDA) approved its use in pill form. Since then, the abortion pill has been used by nearly half a million women in the U.S.
Mifepristone is the generic name for RU-486. In the United States, mifepristone is sold under the brand name Mifeprex®. Mifeprex is manufactured by Danco Laboratories of New York.
Who Should Not Use the Abortion Pill?
Women should not consider using Mifeprex / RU-486 if:
- It has been more than 49 days (7 weeks) since their last menstrual period began.
- They have an IUD (intra-uterine device for birth control).
- They have been diagnosed with a pregnancy outside the uterus (ectopic pregnancy).
- They have problems with their adrenal glands (chronic adrenal failure).
- They take blood-thinning medication.
- They have a bleeding problem.
- They take certain steroid medicines.
- They cannot return for 2 subsequent visits following the first dose of Mifeprex.
- They cannot easily get emergency medical help in the 2 weeks after they take Mifeprex.
- They are allergic to mifepristone, misoprostol, or medicines that contain misoprostol, such as Cytotec or Arthrotec.
What are the Risks Associated with Mifeprex?
Though many providers of medical abortion assert that the abortion pill is generally safe for use, concerns about the risks of Mifeprex use are rapidly growing. In late 2004, the FDA reported having received 676 "adverse event" reports concerning RU-486 abortions, including ectopic pregnancies and severe blood loss.
A more alarming risk attributed to the use of mifepristone is septic shock, or sepsis, resulting from a severe bacterial infection in the bloodstream. If left untreated, septic shock is fatal. Since 2003, several instances of death by sepsis have been associated with the use of Mifeprex.
If you or your loved one has suffered a Mifeprex/RU-486 injury, contact us today. Submit the form to the right and we’ll let you know if you have a case and if we can represent you.