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[IP] Synthroid versus generic brand
Date: Tue, 22 Feb 2000 12:29:06 -0500
> From: "Denise Guerin" <email @ redacted>
> Subject: [IP] Synthroid versus generic brand
> Is there anyone on the list taking generic levothyroxine?
Thanks to all who replied to my question re generic levothyroxine. I
decided to research the subject and would have been at a lost without those
experiences to put the info I found in perspective. I found out that none
of the brands are that consistent in their effect, including Synthroid. I
will ask my endo if he has any new information on this. I never questioned
this before, but I find pumping makes me more aware of the interconnection
of various hormones and my insulin requirements. Below is a resume of what
I found doing a search on "About .com"
Type 1 45 years
"Synthroid and other Levothyroxine Drugs Have Significant Stability and
FDA Takes Action to Require Manufacturers to Demonstrate Safety, Efficacy
. Levothyroxine sodium was first introduced into the market before 1962,
without an approved "New Drug Application" (NDA), apparently in the belief
that it was not a new drug.
Since that time, almost every manufacturer of orally administered
levothyroxine sodium products, including Synthroid, has regularly reported
recalls that were the result of potency or stability problems. In some
cases, problems result from the fact that levothyroxine sodium is unstable
in the presence of light, temperature, air, and humidity. ...
Problems also stem from formulation changes. Because these products are
marketed without NDA's, manufacturers have not had to file for FDA approval
each time they reformulate their levothyroxine sodium products.
Manufacturers have changed inactive ingredients, physical form of coloring
agents and other product aspects, resulting in significant changes in
potency, in some cases increasing or decreasing potency by as much as 30
percent. As a result, in some cases, people on the same dosage for years
became toxic on the same dose. There is evidence that manufacturers continue
to make these sorts of formulation changes which affect potency.
Now, 35 years after their introduction, the U.S. Food and Drug
Administration (FDA) issued notice (Federal Register, August 14, 1997) that
orally administered drug products containing levothyroxine sodium are
officially classified as "new drugs" and will need to go through the NDA
process because of the stability and potency problems that have recently
come to light.
In order to continue marketing these drugs, manufacturers will need to
submit an NDA with documented evidence that each company's product is safe,
effective, and manufactured in a way to ensure consistent potency. Because
the drug is necessary to millions of Americans, the FDA is allowing
manufacturers to continue to market these products without approved NDA's
until August 14, 2000, in order to give the companies enough time to conduct
the various research studies and to submit their NDAs. "
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