Thyroid Shortage Alert

Current News

American Laboratories Issues Statement Regarding Shortage of Natural Desiccated Thyroid Raw Materials

Thursday August 20, 2009

American 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 statement:

August 19, 2009

To our 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.

 Through the 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.

Please be assured that we have placed our Thyroid production as our number one priority so that we can meet the demands of our customers.

 American Laboratories, Inc

Omaha, Nebraska, USA

Not 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.

 Says Dr. 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, which
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 and Westhroid.

 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 2009 Armour/Nature-Throid Natural Desiccated Thyroid Drug Shortage now


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 prescriptions.

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 al., 1999)
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.

DESICCATED THYROID SHORTAGE

CONVERSION TO T3/T4

Manufacturers of Desiccated Thyroid from pork thyroid glands (Forest Labs for Armour, and RLC Labs for Nature-Throid and WesThroid) have recently announced that their thyroid prescription drugs are now on a nationwide backorder status for an unspecified period of time.

Most local pharmacies no longer have these drugs available for dispensing; re-supply from wholesalers and manufacturers is uncertain.

An alternative for patients and physicians to consider would be converting to T3/T4 combinations.  T3/T4 Combinations are custom compounded preparations using liothyronine (T3) USP and levothyroxine (T4) USP powders in a standardized formula.  In addition, the use of a Slow Release capsule format reduces the side affects associated with immediate release tablets.

If you or family members have been taking DESICCATED THYROID but are unable to obtain your this drug, then consider converting to T3/T4 Combinations.  Be aware that these substitutes are NOT IDENTICAL FORMULATIONS to the desiccated thyroid preparations you may have been taking; they are, however, identical to your own T3/T4 hormones.  We will work closely with your prescribing physician to match as nearly as possible the dosage strengths you were previously taking.

If all this seems confusing, it is!

Blue Mountain Apothecary is available to discuss this issue with you and your physician. 
Please phone with your questions and concerns.

Blue Mountain Apothecary
9145 Guilford Road #160
Columbia, MD  21046

301-490-2353     888-248-3266

FAX: 301-490-2376

info@BlueMountainRx.com

 

 

 

 

 

 

 

 

   
 

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Blue Mountain Apothecary
Custom Compounding Pharmacy
9145 Guilford Rd. #160

Columbia, MD  21046
301-490-2353  
FAX: 301-490-2376
TOLL FREE: 888-248-3266
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