Friday, March 9, 2007

More on the generic form of sertraline

Well, I cant just let this go-- let it be a lesson learned and move on.
I cant because I am sure it will be weeks before Honey is back to "Honey normal" again after this lesson, and it is really making me mad.

Found this interesting bit on Zoloft and the generic form written by Michael Craig Miller, M.D. Editor in Chief, Harvard Mental Health Letter

"The FDA requires that a generic drug be essentially similar to the brand-name version. It should contain the same amount of active drug. It must be taken by the same route (for example, by mouth). And at a given dose, it should deliver about the same amount of active ingredient into the bloodstream — anywhere from 20% less to 25% more than the brand-name drug.
It doesn't always deliver exactly the same amount because generic pills contain inactive substances that distinguish them from the original. In fact, the U.S. government actually requires this, to prevent fraudulent marketing. The otherwise inactive substances in a pill can affect how the active chemical is absorbed by the bloodstream, delivered to its target, and eliminated; for example, it may break up faster or more slowly in the gastrointestinal tract."

Should deliver "about the same"????
20% less to 25% more is about the same???

For the life of me, I can not understand why this is acceptable. With ANY drug, but specifically an SSRI.

Because, with an SSRI, it seems that the risk of suicide increases when the dosage of the SSRI is CHANGED (starting/stopping/dosage changes)

On the medication guide (that I just received for the FIRST TIME with Honey's script for Zoloft oral concentrate two days ago) tells me that I should be particularly watchful of Honey whenever an antidepressant is started or its dosage changed.

How could I know that her dosage was being changed, when it was changed without my knowledge or consent... all at the approval of the FDA?

Not like I needed another reason to distrust the FDA.

2 comments:

Monica Cassani said...

excellent post...
it's really disturbing isn't it?
good health to you and your family.

Tony said...

"The FDA requires that a generic drug be essentially similar to the brand-name version. It should contain the same amount of active drug. It must be taken by the same route (for example, by mouth). And at a given dose, it should deliver about the same amount of active ingredient into the bloodstream — anywhere from 20% less to 25% more than the brand-name drug."

Michael Craig Miller, M.D.
Editor in Chief, Harvard Mental Health Letter

http://harvardpartnersinternational.staywellsolutionsonline.com/HealthNewsLetters/69,M0207g/