Laboratories Issues Statement Regarding Shortage of Natural Desiccated
Thyroid Raw Materials
Laboratories, Inc. -- the supplier of Thyroid USP powder, which is the raw
material used to produce natural desiccated thyroid drugs in the U.S. -- has
issued a statement regarding their shortages. Here is the text of their
knowledge, American Laboratories, Inc. is the only manufacturer in North America
of Thyroid Products for use in Human Pharmaceuticals as an Active Pharmaceutical
Ingredient. We have manufactured our Thyroid products for over forty years, and
we understand the importance they have to our customers and ultimately the
consumer patients. Today, as well as in the future, our Thyroid
products will continue to be a strategic part of our business.
years, the world-wide demand for our Thyroid products, as well as our human
nutritional enzyme products has increased dramatically. Through careful planning
and strict adherence to regulations set forth by the FDA, USDA and other
government agencies, we have implemented plans to increase our production
capacities. In addition, American Laboratories is working closely with our
suppliers to help ensure a consistent supply of quality raw materials. We hope
that you understand that the process to manufacture the active ingredient takes
several months to complete.
assured that we have placed our Thyroid production as our number one priority so
that we can meet the demands of our customers.
Omaha, Nebraska, USA
surprisingly, the statement from American Laboratories does
not address quality concerns that
have been raised about their product. As indicated by Dr. John Lowe
in his article about the
desiccated thyroid drug shortage, RLC, the manufacturer of
natural desiccated thyroid drugs Nature-Throid and Westhroid, typically rejects
up to as much as 50% of the raw materials they are receiving from American
Laboratories, for quality reasons.
Lowe: "With synthetic products, chemists produce the compound in volume, and
then, for better or worse, it's available for making the final product. In
contrast, the raw thyroid substance that will end up in Nature-Throid and
Westhroid tablets must be carefully selected based on RLC's specifications,
ultimately derive from the United States Pharmacopeia. The raw substance must
meet the company's specs for standardized concentrations of natural T4 and T3 .
Up to 50% of the substance may be rejected for use in manufacturing Nature-Throid
At a time
like this, when the demand for Nature-Throid and Westhroid have suddenly
skyrocketed, rejecting up to 50% of raw thyroid substance must be frustrating to
those waiting to produce the finished tablets. But RLC Labs won't compromise on
quality, and their specifications must be met.
Read all the news about the
Armour/Nature-Throid Natural Desiccated Thyroid Drug Shortage
Updated Statement from Forest
Laboratories Re: Availability of Armour Thyroid:
Forest Laboratories understands
how frustrating the back order situation of
Armour Thyroid has been for patients, and we
apologize for the supply interruption.
A supply of powdered Thyroid
gland, the active ingredient of Armour Thyroid,
has been made available to Forest by its
supplier. Forest has produced and shipped a
limited supply of 1 grain, also known as 60 mg.
We understand that this limited
distribution will not meet the current
anticipated demand for the product, and we
continue to work diligently to meet demand.
Although Forest is addressing
the backlog of Armour Thyroid as quickly as
possible, we are not prepared at this time to
give a definitive date by which the product will
be fully restocked. Please check for future
updates on the availability of Armour Thyroid
through the Forest product availability
toll-free hotline at (866) 927-3260.
In the meantime, we encourage
patients to speak with their physician regarding
appropriate treatment for their condition.
Recently, Major Pharmaceuticals
issued a press release stating that the US Food and
Drug Administration (FDA) has required them to cease
production of a century old treatment option, a
naturally dessicated thyroid drug , due to a change
in FDA regulatory procedures.
Under their "Unapproved Drugs Campaign", the FDA is
eliminating the regulations that previously allowed
the production and distribution of these effective
drugs. It has been reported that this action could
have caused the shut down of manufacturing at two
other firms. Additionally, the bioidentical hormone
medications, which include Armour Thyroid and
Nature-Throid, are on back-order at several other
distributors. Ironically, there's also been a report
of a national shortage of the Thyroid USP, the
porcine desiccated thyroid raw material used to
create the pills. No official information has been
released by the FDA about the future of these
Use of these drugs formulations began at the turn of
the 20th century, they never went through the
various drug application processes that the FDA
instituted because the drugs were already on the
market. Thyroid patients have anecdotally reported
that these prescriptions have fewer side effects and
increased efficacy. Research results showed that
patients with hypothyroidism may have improved brain
activity and overall mood in comparison to those
patients on Synthroid (thyroxine), the commonly
prescribed synthetic thyroid hormone. (Bunevicius et
Health practitioners and patients have come together
to strategize on keeping these much needed drugs on
the market. The FDA is threatening a consumer's
right to choose a natural treatment option.
Individuals concerned about availability of these
drugs or the health of their thyroid should read
more from About.com's thyroid expert Mary Shomon and
the Save Natural Thyroid Coaltion.
(New England Journal of Medicine;1999;340:424-429)
DENVER, CO -- (Marketwire) -- 09/14/09 -- Forest Laboratories,
Inc., the maker of the widely used hormone therapy drug, ArmourŪ
Thyroid, recently announced it has placed the medication on back
order. The company said on its website that it does not have
enough of the active ingredient, powdered Thyroid gland, in
stock to produce the medication. According to Forest
Laboratories, ArmourŪ Thyroid is considered a natural hormone
replacement therapy because the thyroid glands are collected
from USDA-approved grain-fed pigs. The thyroids are processed,
dried, powdered, and compounded to produce ArmourŪ Thyroid
tablets. The amount of thyroid hormone present in the thyroid
gland may vary from animal to animal.