Oral cytotec induction? - Page 3

[Arwyn]

Hi all. Just a friendly moderator reminder to keep this about the subject of cytotec use for inductions, and relating that to the broader discussion of inductions and birth in general. Please remember that the User Agreement states:

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[doctorjen]

Cytotec will never be FDA approved for induction of labor or any other obstetrical use. To gain FDA approval for a specific indication, medication manufacturers have to show studies that confirm safety and efficacy. The makers of cytotec have no interest in trying to gain FDA approval since the medication is not expensive (therefore making them a lot of money), is already widely in use (meaning there is no further market for them to seek) and has the potential to cause them legal nightmares. Currently, if there is a bad outcome from using cytotec in a pregnant woman the manufacturer is not liable because they have labeling which clearly indicates that they do not support it's use in pregnancy. If they sought FDA approval for pregnancy related indications they would be potentially liable for any bad outcomes.

As far as off-label (meaning not FDA approved) uses of medication, this is a widespread practice. In many cases, manufacturers cannot afford (or, more cynically, don't want to reduce their profits by spending more money) to fund studies to cover every potential use. They usually study the drug for it's most likely uses and seek FDA approval for those uses. Once a drug is available on the market, physicians can legally prescribe for any use they want. Often, studies are done by folks not related to the manufacturer to look at other areas the drug can be used (there are actually dozens of studies of the use of cytotec in labor.) Many times physicians use the information available in those kinds of studies to choose medicines. There are many examples of medications being used for non-FDA approved indications - including things like aspirin to prevent re-thrombosis of the coronary arteries after an angioplasty and stent, or using the diuretic spironolactone for heart failure. There are wonderful studies showing that these drugs are very beneficial in those situations, but FDA approval for those specific uses has not been sought.

The problem with off-label use is that often, drugs get common usage before adequate studies are done, and once practice patterns are established, it can take a long time for safety data to trickle into common practice.

I personally am not sure I'd say cytotec has no place ever in obstetrics, but I wouldn't consider it for any kind of elective induction, including postdates because of the risk benefit profile. It does not make sense to me to take increased risk in a situation that is not time sensitive. For severe pre-eclampsia on an unfavorable cervix? Maybe. In my hospital we only use cytotec by special consent and our consent form includes the information that cytotec is not FDA approved for use in pregnant women and the risks of cytotec and alternatives.

[dinahx]

I personally am not sure I'd say cytotec has no place ever in obstetrics, but I wouldn't consider it for any kind of elective induction, including postdates because of the risk benefit profile. It does not make sense to me to take increased risk in a situation that is not time sensitive. For severe pre-eclampsia on an unfavorable cervix? Maybe. In my hospital we only use cytotec by special consent and our consent form includes the information that cytotec is not FDA approved for use in pregnant women and the risks of cytotec and alternatives.

If it is okay for doctors to use pharmaceuticals in untested, unstudied ways, to "keep costs down", by special consent, therby doing away with the notion that everything in medicine is backed by sound premarket science, why doesn't the same line of reasoning apply to herbs, which have been used and documented for centuries?

(Why doesn't it apply to homebirth, for that matter?)

Just droppin' a little philosophy.
:

[pamamidwife]

there are alot of off use meds, which i think is important to remember. i'm not saying cytotec is fabulous, but i am saying that the off-label use argument is pretty weak from a medical standpoint.

domperidone, for instance, a drug that is used to treat gastrointestinal issues, can also help women with low or no milk supply (adoptive mothers or mother relactating). this is an off-label use.

some anti-seizure meds (one of which i'm on, and thank the world for) are used for bipolar disorder and other mental health conditions that are off-label.

I agree with what doctorjen says about the risks of off-label uses, and the FDA is far from a respectable organization under the current administration.

And heaven forbid if they start regulating herbs and supplements. That is something I definitely do NOT want.

[doctorjen]

Originally Posted by dinahx

If it is okay for doctors to use pharmaceuticals in untested, unstudied ways, to "keep costs down", by special consent, therby doing away with the notion that everything in medicine is backed by sound premarket science, why doesn't the same line of reasoning apply to herbs, which have been used and documented for centuries?

(Why doesn't it apply to homebirth, for that matter?)

Just droppin' a little philosophy.
:

Believe me, if your looking for me to defend the FDA or how most of modern medicine makes decisions on safety and efficacy here, you are looking in the wrong place!!
The "notion that everything in medicine is backed by sound premarket science" is just that: a notion. The real picture is more how I described in my earlier post. Drugs get into use, and then docs start to experiment with them - sometimes with spectacularly positive results and sometimes with not so great results. Although I am a big fan of evidence informed practice, I am well aware of the downsides of scientific evidence. We like to think of it as having no values or emotions attached, but in reality every bit of information arises out of a belief system of some kind. Why do certain things even get studied? Because someone believes there is a benefit somewhere - hopefully based on some kind of scientific knowledge, but often since researchers are human, their beliefs and values drive what they do.
When it comes to drug research and approval in the US at least, so much is financially driven, too. Every drug company wants blockbuster drugs that have widespread use and a good profit margin. Drugs that don't have that blockbuster capability, or older drugs already in common use tend to get studied only if someone is interested in them. Big studies which are more likely to produce usable results require funding, which has to be sought from public (government) sources or private sources (primarily drug companies.) For an individual practioner, you just have to do the best you can with the evidence there is available.

[dinahx]

And heaven forbid if they start regulating herbs and supplements. That is something I definitely do NOT want.

ITA 100% , but there is a movement within the FDA to do just that. I just find it so ridiculous in the face of all these unstudied off-label uses. The FDA paints a picture like pharmaceuticals are tested, studied and FDA approved, and herbs are not, when the reality is that most pharmaceuticals aren't adequately studied, tested, or approved either . . .
/back to topic