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quote: Health officials are investigating whether there are any links in the cases of four California women — at least two in Los Angeles County — who have died since 2003 of massive infection after taking the so-called abortion pill, RU-486, and a follow-up drug.
The state and federal probe follows an announcement last month by the Food and Drug Administration, after the June death of a Sherman Oaks woman, warning doctors and patients of the potential for serious bacterial infection under certain circumstances.
At the heart of the inquiry in California are why and how the deadly infections developed and whether more women might have been harmed.
"That's something we don't have an explanation for right now," said Dr. L. Clifford McDonald, an epidemiologist with the Centers for Disease Control and Prevention, which is investigating the deaths along with the Food and Drug Administration, the California Department of Health Services and the Los Angeles County Department of Health Services.
The FDA is also working with the makers of the two drugs to see if they were contaminated with an unusual bacterium found in the bloodstream of two of the women who died. Complicating matters, neither woman showed all of the usual symptoms of an infection.
The medical mystery in California is fueling the already charged debate over the risks, rights and morality of abortion.
It looks like some off-label use of the follow up treatment is a link between the four cases. But I thought avoidable deaths of adult women were the whole impetus behind legalization of abortion generally and the making available of this drug.
Oh, and I apologize in advance if this is "old hat".
Posts: 2010 | Registered: Apr 2003
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All the deaths used an off-label but not counterindicated vaginal application of the follow up drug. Is that what you meant?
By off-label, I believe that means the use was prescribed by a doctor but is not approved by the FDA. Off-label use covers all use of drugs by children (since it is not legal to test drugs on children) and uses of drugs such as neurontin for anything other than epilepsy. It's a very common practice. I don't know if it's possible to get statistics, but I'd bet 1/4 to 1/3 of prescriptions are off-label.
So it's not a simple matter of saying "oh, these people were misusing the drug". They were doing so under doctor's instructions as a generally accepted medical practice.
Posts: 2010 | Registered: Apr 2003
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I was more curious as to 4 deaths "out of how many" and how that rate compared to the mortality rates of childbirth and other forms of deliberate abortion. I don't know how to even begin to interpret the numbers otherwise -- 4 deaths out of 20 women taking the drug would be a lot different from 4 deaths out of 20,000 taking the drug.
Not trying to be difficult, I promise. Just at a loss to assess.
Posts: 14017 | Registered: May 2000
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Just at a loss to assess.
