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Re: The truth about Cytotec...

From: D. Ashley Hill, MD (anonymous@obgyn.net)
Mon, 4 Sep 2000 22:13:17 -0500 (CDT)


At Fri, 1 Sep 2000, S wrote:

Recently, Searle send a letter to >ob/gyns across the country on the dangers of the off-label use of this
>drug. It is becoming more widely used and does NOT have FDA approval
>for use for induction

Pharmaceutical companies gain FDA approval by doing studies and submitting these results to the FDA. It is extremely expensive and time-consuming to do this. The majority of medications used in ob/gyn are not FDA approved for the conditions we use them to treat. For example, the only medication specifically FDA approved to stop preterm labor is ritordrine, but I do not know of any ob/gyn doctors who use this medication. Other medications appear to be safer and more effective, as suggested by hundreds of medical studies. The drug companies have simply declined to go through the hoops to seek FDA approval for that indication.

Another example: Ortho tri-cyclen is "FDA approved to treat acne" yet almost all birth control pills will do the same thing. The other companies did not submit their pills for specific FDA approval for acne. The only FDA approved medication to treat nausea and vomiting in pregnancy (to my knowledge) is bendectin, a medication no longer produced in the United States!

So, whether or not misoprostol is FDA approved for induction has nothing to do with it's safety or effectiveness. The Searle letter was *clearly* written by lawyers. Although I do not use it for inductions for patients with a prior c/section, myself and hundreds of other ob/gyn doctors, who have carefully reviewed the scientfic literature, use it for inductions in other patients. It is also used to induce labor for patients who have fetal anomalies, and those who have an incomplete miscarriage.

--
David Ashley Hill, MD
Associate Director
Department of Obstetrics and Gynecology
Florida Hospital Family Practice Residency
http://home.cfl.rr.com/dahmd

My apologies, but due to time constraints I am unable to answer private e-mails.




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