Medical Abortion Deaths

Posted on June 09, 2008 in Medicine news

Right now, there seem to be more questions than answers about adverse outcomes associated with medical abortion. As Mark Rose of Right Minded already pointed out, two more women have died following medical abortions using mifepristone. Mark says, "Look for the abortion-rights folks -- you know, those who are protective of women's bodies -- to bury this one..." Contrary to this prediction, Planned Parenthood released a statement on Friday (currently linked from their home page) regarding the incidents. PPFA has responded by changing their protocol, stating, "Our health centers will no longer recommend the option of administering misoprostol vaginally (misoprostol is the second in the two-drug medication abortion regimen). Patients will now receive misoprostol orally or buccally (where the pill is placed between the cheek and gum and dissolves). This change in protocol is effective immediately." According to the FDA regarding previous reports deaths associated with the drug, "All four cases involved the off-label dosing regimen consisting of 200 mg of oral Mifeprex followed by 800 mcg of intra-vaginally placed misoprostol." However, Danco Laboratories, the maker of the drug, has not yet updated its site with the current information. This is an interesting story on several points. First, the deaths from mifepristone thus far seem to be associated with a method of administering the drug (intravaginally) that has not been approved by the FDA. The FDA does not prohibit off-label use of drugs, but says, "If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects." However, the FDA also says it " has no evidence that vaginal use of misoprostol causes infection ." Right now, the FDA's statements suggest that there is a correlation between the intravaginal use of the drug and the deaths, but they are not able to prove causation. So, what information led prescribers to use the drug intra-vaginally? Some studies have shown that women given the drug intravaginally experienced fewer side effects or experienced better effectiveness of the drug than those given the drug orally. Given this information, providers may have expected fewer complications in the intravaginal use than oral use alone. Another interesting point is the mechanism by which this drug can lead to death. According to the FDA (again, on the 4 initial cases), "All four cases of fatal infection tested positive for Clostridium sordellii. In addition, FDA tested drug from manufacturing lots of mifepristone and misoprostol and found no contamination with Clostridium sordellii." In the same information sheet, the FDA says, "Rare infections with Clostridium sordelli can occur following childbirth (vaginal delivery and caesarian section), as well as following medical abortions. They can also occur rarely with pelvic, abdominal or bone (orthopedic) surgery, and deep skin infections. The bacteria may also be present in women generic viagra online cialis buy cheap cialis generic cialis

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