PCOS-DIET Messages for August, 2001: Re: Pill/Diet...Questions Dr Wadsworth

Re: Pill/Diet...Questions Dr Wadsworth

From: Renee (anonymous@obgyn.net)
Wed, 08 Aug 2001 19:18:47 -0700

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Glucophage XR is Met in extended release form (met is the generic glucophage).

Met is FDA approved for type II diabetes. PCOS use is "off-label."

The way the FDA approves drugs (nationwide--no state does it) is by reviewing the data the manufacturer provides. The manufacturer conducts studies, (there are 4 phases of trials), looking to see if it works and is safe for the targeted population (people with a certain problem or need). Metformin was tested for diabetes II. The FDA then approves or declines approval for the drug. They also determine if the data shows it's effective for the different conditions. Every condition they find it is effective for is an "on-label" use. The manufacturer is able to make those claims in their advertising and literature. ("Drug X had this effect in these people.")

However, once a drug is approved, doctors may choose to use it for different conditions, as "off-label" uses. This might be because it hasn't been tested at all for that condition (some docs might think it would be helpful, and try it out). Or, it might have been studied (eg: using Met for PCOS fits here), but the manufacturer never did trials to submit to the FDA. This is very common. Once they get it on the market, they let people use it how they want. It's expensive to go through FDA approval for just another indication (usage) if it's already approved for one thing, so they don't bother. They know people will study it for other uses, and get it into wider circulation. The only risk is, if there is a problem with the drug, the doctor could face some liability issues for using it "off-label." Again, it is up to the physician to act responsibly and review the literature out there.

I hope this makes sense.

Renee

Lori wrote: >
> Nikki,
>
> I live in NY and my Endo told me that Met has not been approved by the
> FDA here. I am going to start taking Glucophage XR. Have you tried
> this?
>
> --
> Lori, New York
>

-- Renee Cordrey, MSPT, MPH, CWS

---

Don't follow in the footsteps of the masters. Seek what they sought. --Zen saying

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