What's up with desiccated thyroid
& the FDA?
On Friday, August 28, 2009 the FDA began
releasing much awaited information regarding the status of desiccated thyroid
products (Nature-throid by RLC Labs and Armour by Forest
Pharmaceuticals). Over the last year Time Caps decided that it
would cease production of their desiccated thyroid (DT) after being contacted by the FDA
regarding issues with its products. Time Caps was a supplier of
desiccated thyroid to RLC Labs - the maker of Nature-throid. This
put a crunch on RLC and caused them to get behind in production.
On Thursday, August 27, 2009, Major Pharmaceuticals announced that they were ceasing production of their desiccated thyroid product after receiving word from the FDA that they could no longer produce it.
The loss of these two companies as well as Biotec last year has left a huge deficit in the desiccated thyroid market with more demand than supply. Then to complicate this issue there were the recalls from Forest Pharmaceuticals in 2007.
In November 2007, Forest Pharmaceuticals issued a voluntary recall of Armour Thyroid tablets in 3 gr, 4 gr and 5 gr doses. This caused shortages of the lower doses over the next year as Forest worked to correct the issue of disinitegration (reason for the recall) by reformulating the product. This reformulation increased the cellulose and decreased the dextrose in the tablet. Patients getting this new product knew immediately that something had changed. The tablets had lost their sweet taste, shiny coating and were chalky in consistancy. Forest did not notify pharmacists or doctors that this change had occurred. In the weeks and months to follow patients began to notice a return of hypothyroid symptoms that once had been relieved on the same dose. Many tried to adjust their doses but found it difficult to get stable once again. Others had immediate reactions such as buzzing in their ears, increased heart rates, sweating, hot flashes, itching of the skin and inner ears, vomiting and more. The list went on. Frustrated, patients began to contact their doctors about switching their prescription to Nature-throid. When word got out on the thyroid health boards that Nature-throid was working better, more flocked to get their prescription changed. The increased demand for Nature-throid overloaded RLC's production and caused a backlog at their facility as they worked diligently to keep up.
Then in mid-August 2009, the announcement came from both Forest Pharmaceuticals and RLC Labs that there would be a backorder of all desiccated thyroid products. RLC released a target date of 90 days but as of this point Forest has yet to project its release date. The reason that was given for this backorder was a nationwide shortage of raw material ( Thyroid USP ) which is manufactured by American Laboritories, Inc.
On Thursday, August 27, 2009, Major Pharmaceuticals announced that they were ceasing production of their desiccated thyroid product after receiving word from the FDA that they could no longer produce it.
The loss of these two companies as well as Biotec last year has left a huge deficit in the desiccated thyroid market with more demand than supply. Then to complicate this issue there were the recalls from Forest Pharmaceuticals in 2007.
In November 2007, Forest Pharmaceuticals issued a voluntary recall of Armour Thyroid tablets in 3 gr, 4 gr and 5 gr doses. This caused shortages of the lower doses over the next year as Forest worked to correct the issue of disinitegration (reason for the recall) by reformulating the product. This reformulation increased the cellulose and decreased the dextrose in the tablet. Patients getting this new product knew immediately that something had changed. The tablets had lost their sweet taste, shiny coating and were chalky in consistancy. Forest did not notify pharmacists or doctors that this change had occurred. In the weeks and months to follow patients began to notice a return of hypothyroid symptoms that once had been relieved on the same dose. Many tried to adjust their doses but found it difficult to get stable once again. Others had immediate reactions such as buzzing in their ears, increased heart rates, sweating, hot flashes, itching of the skin and inner ears, vomiting and more. The list went on. Frustrated, patients began to contact their doctors about switching their prescription to Nature-throid. When word got out on the thyroid health boards that Nature-throid was working better, more flocked to get their prescription changed. The increased demand for Nature-throid overloaded RLC's production and caused a backlog at their facility as they worked diligently to keep up.
Then in mid-August 2009, the announcement came from both Forest Pharmaceuticals and RLC Labs that there would be a backorder of all desiccated thyroid products. RLC released a target date of 90 days but as of this point Forest has yet to project its release date. The reason that was given for this backorder was a nationwide shortage of raw material ( Thyroid USP ) which is manufactured by American Laboritories, Inc.
|
As
would be expected in this situation, patients fearful that they would
be forced to once again take Synthetic T4 only medication. The
same medication that had not worked for them previously.
All the while knowing the suffering that accompanied it,
they began to try to stockpile their medication. The situation
could be likened to the run on the banks in the great depression.
Panic ensued as more and more found that pharmacists were not
able to obtain their prescriptions. Many being told that it was
being discontinued.
Rumors began to circulate that the FDA had decided to eliminate all desiccated thyroid products. This was fueled by pharmacist and doctors alike. But the final blow to this rumour was when MEDCO, a major mail order pharmacy, released a notice to doctors suggesting that no natural desiccated thyroid drugs were available and that the FDA intended to take these drugs off the market. ( See Mary Shomon's Blog Aug 6, 2009 ) . MEDCO defended itself stating that they were contacted by manufacturers with this information. ( More information ) Fear once again struck the patients on desiccated thyroid as they worried that their life giving medication would be taken away from them. After numerous calls to the FDA that availed no guarantees of its safety from removal, masses of patients began to step up their calls to the FDA demanding an answer. This answer was delivered in several forms. The official statement is recorded in Mary Shomon's blog dated August 28, 2009. The statement that was released did not give any thyroid patient depending on desiccated thyroid *warm fuzzies* that they were safe and out of the woods. What we do know from calls to RLC and ALI that they are working hard to get back on top of the backorder situation and they are trying hard to get their products out as fast as they can. Until then if you have a need for thyroid medication and do not wish to switch to synthetics. Please check with your local compounding pharmacy to see if they can make your medication for you. It is the same base thyroid but without the fillers contained in Armour or Nature-throid. |
RLC Labs - Nature-Throid & Westhroid
The Metamorphosis Design : 2008