Letters To & From the FDA

Letters To The FDA

Dr. Kenneth N. Woliner
August 27, 2009

Letter From the FDA

FDA Division of Drug Information
August 29, 2009


However, for a variety of historical reasons, some drugs, mostly older products, continue to be marketed illegally in the United States without required FDA approval. Many healthcare providers are unaware of the unapproved status of these drugs and have continued to unknowingly prescribe them because the drugs’ labels do not disclose that they lack FDA approval. Often these drugs are advertised in reputable medical journals or are included in widely used pharmaceutical references such as the Physicians’ Desk Reference (PDR).

Marketed Illegally??  Seems they were out in full view being sold in drugstores all over the country.  Desiccated thyroid was given a special status to allow it to be used due to its existance prior to the FDA's creation.  Until 2006 when the FDA decided that they wanted to eliminate all drugs not on their approved list desiccated thyorid was not an issue.  It has been safely used since the 1890's.  Just because it is not on the "approved" list does not mean that it is not safe. Take a look at many of the drugs that have been pulled from the market after approval or have black box warnings on them.  

Fortunately, there are approved drugs that are currently available. Thyroid medications require close monitoring because precise dosing is critical for effective control of hormone levels. Physicians make sure patients get the correct dose of medicine by performing physical examinations and regularly checking thyroid stimulating hormone (TSH) levels through simple blood tests.

This statement is problematic for those of us on desiccated thyroid for two reasons.  Many of us have tried synthetic T4 only drugs which did not eliminate our symptoms so we were switched by our doctors to desiccated thyroid.  Second, if the definition of being properly treated is to have a TSH within the range then we will all remain hypothyroid and more than likely with remaining symptoms.  The mechanism of desiccated thyroid will quickly reduce TSH to what would be considered hyperthyroid to many doctors who are lab test watchers and do not go by clinical symptoms as well.  

Medications for underactive thyroid work by replacing hormone that's missing. The approved medication for this indication is levothyroxine sodium, which is identical to the natural thyroid hormone produced by the body. Examples of brand names for levothyroxine are Synthroid, Levoxyl, and Levothroid.

Unfortunately they care comparing apples to oranges.  For those of us without a thyroid (especially), T4 hormone only drugs do not provide the hormone that is missing.  The normal thyroid gland creates T1, T2, T3 and T4 plus calcitonen.  Where do these come from if not supplemented?  Others have issues with conversion of T4 to T3 in the liver and kidneys.  Blood tests will reveal higher T4 levels but T3 levels that are in the tank. T3 is the metabolic hormone and necssary for many functions of the body.  When deficient the door is open to disease.  A long and pathetic list of symptoms can be found HERE.  This list was compiled by real patients who suffered on T4 medication before finding releif on desiccated thyroid.  

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