CITYSunTimes Web Exclusives February 2010
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HEALTH & WELLNESS
By Steven P. Timmons
There are several known thyroid hormones used to treat patients with low thyroid levels or symptoms of low thyroid (hypothyroidism). The hormones are named based on the number of iodine atoms present in the molecule: T1, T2, T3 and T4.
T3 is also called liothyronine and is prescribed separately as Cytomel. T4 is also called L-thyroxine and is prescribed separately under a variety of trade names, the best known trade name being Synthroid. T1 and T2 are only prescribed as a part of desiccated thyroid, which is the natural porcine glandular material, in a dried and standardized form. This form of thyroid is also called natural thyroid, and some of the common trade names are Armour thyroid, Nature-throid, and Westhroid. Desiccated thyroid contains all four thyroid hormones: T1, T2, T3 and T4, along with small amounts of calcitonin and other molecules present in the thyroid gland.
Many patients, because of their unique metabolism, cannot regulate their thyroid condition using only L-thyroxine (T4) or liothyronine (T3) in the separate form. Unfortunately, these patients have just discovered that they cannot fill their prescriptions. The companies who have been manufacturing desiccated thyroid tablets have been in a holding pattern for several months, unable to make their products.
Desiccated thyroid tablets have been made for much longer than the FDA has been in existence. These products were considered “grandfathered,” and never had to pay for the costly FDA approval process, an investment that can only be recovered for a product, which will then remain on patent. Thyroid glandular material cannot be patented, and this means that if the FDA now decides to insist on approval, many thousands of patients may not be able to obtain their medication.
It is difficult to find out what is really happening with the thyroid shortage. The drug companies have little to say. Several websites have published accounts that would lead us to believe that the FDA is insisting that desiccated thyroid is a new drug, which needs to be approved in order to be manufactured. There is a good review on About.com.
For the time being, when a physician specifically requests that desiccated thyroid should be compounded into capsule form for a specific patient, compounding pharmacies may be able to fill this type of prescription by creating capsules. The final prescription would not be in a compressed tablet form, but rather a capsule, and a prescription for Armour thyroid is not legally considered the same as a prescription for compounded thyroid. The exact milligram amounts can be targeted toward whichever thyroid product the patient has been taking, but some differences may be noted and patient dosing may need to be modified by the physician as time goes on.
Call your compounding pharmacy if you need help in understanding how your physician might need to write this type of prescription until the tablets become available. We are all hoping that the FDA decides to allow the continued production of this life-saving medication by the manufacturers.
HEALTH & WELLNESS Web Exclusive | CITYSunTimes February 2010