Tuesday, November 16, 2004

Mifepristone (RU-486) Labeling Changes

As a result of several reports of infection, heavy bleeding, ectopic, and ?two deaths in women using mifepristone, the FDA has announced labeling changes:

The new warnings to health care providers and consumers include changes to the existing black box on the product to add new information on the risk of serious bacterial infections, sepsis, and bleeding and death that may occur following any termination of pregnancy, including use of Mifeprex. While these risks are rare, the new labeling and Medication Guide will provide the latest available information to all.

Because I think the FDA's release is a bit confusing (and odd), allow me to clarify.

The risks mentioned by the FDA (infection, bleeding, ectopic, death) have nothing to do with mifepristone. In other words, it's not the drug that causes them, it's ending a pregnancy. It doesn't matter how a pregnancy is ended--by delivery, spontaneous abortion (miscarriage), or elective (medical or surgical) abortion. Ending a pregnancy, even an early one, is associated with certain risks. For example, with both a term delivery and a 6 weeks miscarriage there is a risk of incomplete delivery of the products of conception. These retained fragments can cause infection, and/or bleeding. And, of course, there is always the risk that a pregnancy will develop in an abnormal location [an ectopic pregnancy]. An ectopic, if undiagnosed and left untreated is very dangerous because it will eventually rupture and cause massive bleeding.

As an aside, I had a young patient who, while being wheeled to the OR for a suspected ectopic, was sitting up on the stretcher, chatting and being very pleasant. Ten minutes later when we opened her up, we found almost half a liter of blood in her abdomen (the ectopic had ruptured and she was actively bleeding internally). The human body--amazing, indeed.

Returning to the FDA release, what struck me as odd (and a bit worrisome) is the fact that the FDA refers to these known and established risks associated with any termination of pregnancy as "new information". I mean, what health care professional (or, for that matter, medical student) isn't familiar with these risks?

Bottom line:

Mifepristone (Mifeprex) is one of the drugs used for early MTP. Like any medication there are side effects associated with using this drug. For mifepristone, they are:

  • headache/dizziness

  • nausea/vomiting

  • diarrhea

  • back pain

  • tiredness

  • In addition, there are certain side effects associated with ending a pregnancy. For a pregnancy that ends as a result of delivery, spontaneous abortion (miscarriage), or elective termination there is a risk of:

  • infection

  • heavy bleeding

  • ectopic

  • If you decide to carry a pregnancy to term, or terminate a pregnancy, please make sure you, and your physician are familiar with the associated risks.

    TIP: Very important for an early pregnancy--ask your physician to explain to you exactly how she/he knows the pregnancy is not ectopic.

    Remember, as a general rule: a pregnancy is an ectopic until proven otherwise.

    (via Drudge)


    At 1:29 PM, Blogger CE Petro said...

    Along with the labeling changes, several extreme-right congresspersons are reintroducing "Holly's Law" (named for Holly Patterson who died from a secondary infection after taking mifepristone). There are companion bills in the House and Senate.
    The day after announcing the "black box" requirement for mifepristone, the FDA announced a black box label for Depo-Prevera as well. http://cepetro.blogspot.com/2004/11/hollys-law-and-depo-prevera.html

    The Washington Times, today has an article about the reintroduction of the bills to ban mifepristone: http://cepetro.blogspot.com/2004/11/reintroducing-ban-on-mifepristone.html


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