Mifeprex (RU-486) Side Effects and Risks

The FDA (Food and Drug Administration) has required the highest level of drug warning, a black box warning, for Mifeprex (RU-486), the drug called the abortion pill. The FDA issued a Public Advisory warning about the risks of using Mifeprex on July 19, 2005. The manufacturer, Danco Laboratories of New York, was required to warn health care professionals about dangers related to death, serious infection, and excessive bleeding that might be related to Mifeprex use. In a November 4, 2005 update, the FDA acknowledged that four women who died of septic shock in California were all infected by the same bacterium, a bacterium that rarely causes infections.

Danco Laboratories sent out a new warning letter to health care practitioner on July 19, 2005, warning heath care providers of the symptoms of infection after the use of Mifeprex. The letter warned that:

  • Providers should be aware that serious infections, including cases of septic shock, have occurred.
  • Providers should be aware that serious cases of infection and sepsis, including infection with Clostridium sordelli, can occur without fever or abdominal pain.
  • Providers should be aware of symptoms of infection, including weakness, nausea, vomiting, or diarrhea, more than 24 hours after the administration of misoprostol, the drug administered two days after Mifeprex.

 

Check out the following articles for more information about Mifeprex, filing a Mifeprex lawsuit and finding a Mifeprex attorney.

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