Natural Desiccated Thyroid Drugs: An Update

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Natural Desiccated Thyroid Drugs: An Update

_http://thyroid.about.com/od/thyroiddrugstreatments/a/natural-thyroid-drugs-

2010.htm?nl=1_

(http://thyroid.about.com/od/thyroiddrugstreatments/a/natural-thyroid-drugs-2010\

..htm?nl=1)

 

 

Here we are in early March of 2010, and, not surprisingly, it can still be

difficult -- and sometimes impossible -- for thyroid patients in the U.S.

and around the world to get natural desiccated thyroid drugs. For the time

being, however, the situation has improved, as drugs are shipping from the

two major U.S. Manufacturers of natural desiccated thyroid medications.

 

At the _Save Natural Thyroid Coalition_

(http://www.savenaturalthyroid.com/) , activities are still underway to work

behind the scenes with

physicians around the country, and to help spearhead grassroots outreach

efforts by

patients, with the goal of promoting the awareness and legitimacy of

prescription natural desiccated thyroid drugs as a safe, legal option for

thyroid

patients. The group also maintains an active _Save Natural Thyroid

Facebook page_

(http://www.facebook.com/pages/Save-Natural-Thyroid/121680434089)

with almost 7,000 members, and a _database of pharmacies where natural

thyroid drug prescriptions can be filled_

(http://spreadsheets.google.com/ccc?key=0AuxvTOzwcw3BdDQ4WkJwZkZMRXNUU1NaZ1poalR\

5TFE & hl=en) .

 

 

The Legal Status of Natural Desiccated Thyroid

 

 

Information from the FDA is, as usual, very limited. A brief _status

update on " Current Drug Shortages " posted at the FDA website_

(http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm#thyroid) on

March 2, 2010,

states that, as of February 12, 2010:

 

**Forest reports manufacturing issues involving the raw material and RLC

reports increased demand. FDA has not ordered Forest or RLC to remove these

thyroid (desiccated) tablets from the market. This has been a long term

shortage and any new information will be posted as soon as it becomes

available. FDA approved levothyroxine products continue to be available from

multiple manufacturers.**

 

 

It's good to see that the FDA felt it necessary to include the brief

statement that they have not ordered Forest or RLC to remove these thyroid

(desiccated) tablets from the market. This very likely reflects a concern on

the

part of the FDA that it not be perceived as taking action that can

endanger the many thyroid patients who rely on natural thyroid drugs, and may

be a

response to thousands of inquiries by telephone, email and fax the FDA

received from thyroid patients and practitioners regarding concerns about

various FDA actions regarding natural desiccated thyroid drugs.

 

 

The FDA's statement does not address a critical issue for thyroid patients

however. According to the natural desiccated drug manufacturers, the FDA

has indicated that they still consider natural desiccated thyroid drugs

" unapproved, " and intend to call for a new drug application process for natural

desiccated thyroid drugs.

 

 

This leaves us with several important questions:

 

-- When will the FDA requirement for new drug application for natural

desiccated thyroid drugs be issued?

 

-- Will the FDA call for the faster (and less costly) abbreviated new drug

application (ANDA) or the lengthier, costlier complete new drug application

(NDA) process?

 

-- Will natural desiccated thyroid drugs be allowed to remain on the market

during the ANDA/NDA process?

 

 

We still do not have answers to these questions, though manufacturers are

still working behind the scenes with the FDA and with their own scientific

experts, doing their best to ensure that natural desiccated thyroid drugs

will continue to be available in sufficient supply to all patients who need

them in the short term, and throughout a federally-mandated approvals

process.

 

 

The Status of Nature-Throid

 

 

Increasing quantities of Nature-Throid are available in pharmacies around

the U.S., I had a chance to speak with Dai Jinn, Chief Pharmacist and Chief

Science Officer at RLC Laboratories, on March 2, 2010, and he indicated

that RLC is well-stocked with raw materials to meet increasing demand for

Nature-Throid, and increasing quantities of the 1 grain are shipping to

distributors and pharmacies.

 

 

While the main ingredients of Nature-Throid were not reformulated, Jinn

indicated that he directed several changes to the production of

Nature-Throid, to ensure optimal quality and consistency. One change was to

switch from

the use of _sodium starch glycolate_ (http://www.pformulate.com/nastgly.htm)

as a dissolution/ disintegrating agent) to _croscarmellose sodium_

(http://en.wikipedia.org/wiki/Croscarmellose_sodium) .

 

 

The purpose of a disintegrating agent is to help a tablet dissolve in the

appropriate place in the intestinal tract, at the right time, to ensure the

maximum effectiveness of the active ingredients. Jinn felt that the

croscarmellose sodium would provide superior dissolution and disintegration for

Nature-Throid. The new Nature-Throid 1 grain also has less of an odor, which

is due to the use of a new coating, which according to Jinn allows for

better quality control for the Nature-Throid tablets.

 

 

RLC has no concerns regarding availability based on demand projections,

and expect their ½ grain tablets to begin shipping by April 1, 2010, and

their ¼ grain by April 10, 2010.

 

 

The Status of Armour Thyroid

 

 

Forest Laboratories has their latest statement regarding the availability

of Armour Thyroid posted at their _Armour website_

(http://www.armourthyroid.com/) , and it states:

 

 

" Forest Laboratories is working diligently to resolve the back-order

situation on Armour Thyroid. We are focusing our efforts on producing the 1

grain (60 mg) and 1/2 grain (30 mg) dosage strengths because these strengths

account for approximately 70 percent of Armour Thyroid use and can be used

alone or in multiples to achieve common total daily dosage requirements. We

have recently produced and shipped a limited supply of 1 grain and ½ grain

tablets, which we expect will start becoming available to pharmacies in early

February. We will continue to ship more lots of Armour Thyroid as they

become available. We appreciate your understanding as we manage this Armour

Thyroid back-order. If you have any questions about Armour Thyroid, please

call the following toll-free hotline: 1-866-927-3260.

 

 

The increasing availability of Armour Thyroid has been confirmed by

patients, who are reporting that their pharmacies are getting shipments of 30

and

60 mg (1/2 and 1 grain) Armour Thyroid.

 

 

In discussions with Forest Laboratories (_which still will not officially

speak to or respond to media inquiries regarding their thyroid drugs_

(http://thyroid.about.com/b/2009/12/07/forest-laboriates-refuses-comment-thyroid\

..ht

m) , and will only answer direct patient inquiries) patients have

reported to me that Forest representatives have said that the company intends

to

continue producing the _reformulated version of Armour that came

(unannounced) onto the market last spring_

(http://thyroid.about.com/b/2009/07/02/armour-reformulation.htm) and caused

problems for a subset of patients.

 

 

The Status of ERFA Thyroid

 

 

In May of 2005, pharmaceutical manufacturer ERFA Canada bought " Thyroid, "

which was the brand name for Canadian desiccated thyroid from Pfizer Canada

Inc. By late 2005, ERFA released their first batches of Thyroid onto the

market, and have continued to produce their natural desiccated thyroid drug

since that time. During the 2009-2010 shortages, some U.S. patients have

ordered _ERFA Thyroid_ (http://thyroid.erfa.net/) via prescription from

Canada, and have found it to be an acceptable, quality brand of natural

thyroid. Availability of ERFA has been good, however, concerns remain regarding

reliance on a medication produced outside the U.S., that must be imported

into the U.S. Some patients have reported that their shipments of imported

thyroid medications have been confiscated by U.S. Customs officials, and

returned to the senders, while others have been using ERA for several years,

with no difficulties importing their shipments. Federal regulations regarding

importation of drugs into the U.S. for personal use are imprecise at

present, however, and importation of drugs from Canada for personal use depends

on loose enforcement and " turning a blind eye " by various federal

officials, a situation that could change at any time.

 

 

The Status of Compounded Natural Desiccated Thyroid

 

 

Some patients remain on prescription _compounded natural desiccated thyroid

drugs_

(http://thyroid.about.com/b/2009/09/30/compounded-natural-desiccated-thyroid.htm\

) , , and compounding pharmacies report sufficient availability

of raw materials, and no difficulties meeting demand for compounded

natural desiccated thyroid drugs.

 

 

More information on compounded natural desiccated thyroid is available _in

this article_

(http://thyroid.about.com/b/2009/09/30/compounded-natural-desiccated-thyroid.htm\

) .

 

 

Follow the Natural Desiccated Thyroid Issue

 

 

To follow the natural desiccated thyroid issue, here are some pages to

bookmark:

 

-- _Armour Thyroid and Nature-Throid Natural Desiccated Thyroid Shortage:

A Summary of Coverage from 2009 through 2010_

(http://thyroid.about.com/od/thyroiddrugstreatments/tp/desiccated-thyroid-2009.h\

tm)

 

-- _Save Natural Thyroid Coalition: Facebook_

(http://www.facebook.com/pages/manage/#/pages/Save-Natural-Thyroid/121680434089)

-- support

group/information page

 

-- _Save Natural Thyroid Coalition_ (http://www.savenaturalthyroid.com/)

-- web page

 

-- _Mary Shomon on Facebook_ (http://www.facebook.com/MarySho)

 

-- _Mary Shomon's Thyroid News on Twitter_

(http://www.twitter.com/ThyroidMary)

 

 

 

 

Thyroid Drugs & Treatments

* _Armour Thyroid and Nature-Throid Natural Desiccated Thyroid S…_

(http://thyroid.about.com/od/thyroiddrugstreatments/tp/desiccated-thyroid-2009

..htm)

* * _Armour Thyroid's Spring 2009 Reformulation Causing

Problems_

(http://thyroid.about.com/od/thyroiddrugstreatments/a/armour-reformulation.htm)

* * _How Do You Remember to Take Your Thyroid Medication:

Patients Share C & helli..._

(http://thyroid.about.com/u/ua/thyroiddrugstreatments/rememberthyroidpills.htm)

* * _Swine Flu and Desiccated Porcine Thyroid Medication From

Pigs: _

(http://thyroid.about.com/od/thyroiddrugstreatments/tp/swine-flu-armour.htm)

* * _When Patients Won't Take Their Thyroid Medication_

(http://thyroid.about.com/od/thyroiddrugstreatments/a/refusingmeds.htm)