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Re: ovarian cysts&more(Lupron Question)From: Laurie (anonymous@obgyn.net)Fri, 2 May 1997 07:17:40 -0500 (CDT)
At Fri, 2 May 1997, Susan wrote: > >At Thu, 1 May 1997, Luanne wrote: >> >>Would you clarify the differences between Lupron and Lupron >>Depot--including the differences in their uses and FDA approval? >> >>Thanks, Luanne >> >>At Wed, 30 Apr 1997, Susan wrote: >>>As I stated in my other message referrenced above, Lupron Depot is only >>>approved >>>by the FDA for use pre-surgically for women who are anemic due to >>>fibroids. THe >>>use of this drug in your case may have been inappropriate based on these >>>guidelines.
>Dear Luanne, Actually, Depot-Lupron HAS been approved by the FDA for use in endometriosis for up to six months (this is excruciatingly obvious by the ad campaigns the company has mounted in the OB/GYN journals). In addition, Depot-Lupron is approved for the treatment of central precocious puberty in children, and as palliative therapy for prostate cancer (not that I personally have ever used it for that! :-) ) The difference between Lupron and Depot-Lupron is that the Depot form is an intramuscular injection that is long-lasting (one month), while the regular Lupron is a subcutaneous injection that is short-acting (a day or so). Unfortunately, there is no oral form available. The issue of FDA approval is interesting--once a drug has been approved by the FDA for ANY reason, a doctor can use it for any reason he desires. This is supported legally if there is a body of evidence indicating that the drug is effective for the way the doctor is using it, even if not "officially" indicated. The best examples of this I can think of are (1) preterm labor: the only drug approved by the FDA for this use is ritrodrine. In the three hospitals I've done obstetrics in, I've never even seen that drug. We've always used terbutaline (Brethine) or magnesium sulfate. (2) Ortho-TriCyclen as treatment for acne: we've always known the birth control pills help with acne, but it's never been approved for that indication until very recently. Ortho-TriCyclen is currently the only birth control pill approved for that, but it's certainly not the only one that's effective. This is not intended as a "slam" on Susan, who has given everybody a lot of good information, but just in the interest of propagating correct information.
-- Laurie Lovely, MD RE fellow, UNC-Chapel Hill
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