Chat: Repost: Levoxyl vs Synthroid- Unithroid too --> Bonnie

[Guest guest]

Hi Bonnie,

Was taking Synthroid for 5 years <-- miserable time with it!

Started Unithroid 8 months ago _MUCH_ better!!

Hope it will do as well for you as it does for me.

The company that manufactures Synthroid has changed hands so many times in

the past 5 years

that, like an old pair of shoes, is worn out. Some.. find old shoes comfortable,

but I find them un-serviceable.

Nick

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Repost follows:

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Date: Wed, 21 Feb 2001 12:01:48 -0500

Subject: Unithroid: <-- more detailed Company info. etc.

To All,

" Unithroid. Unithroid was previously produced under the names levothyroxine

sodium and Thyrox for more than 10 years, with 1 billion tablets

manufactured without a recall. Unithroid is now available by prescription only,

and can be found at your local pharmacy. "

(The above quote is from an article written by Shomon and can be found in

it's

entirety via the following URL address:)

http://thyroid.about.com/health/thyroid/library/weekly/aa021501a.htm

To date, the only levothyroxine to receive approval is Unithroid, a product

of Jerome s Pharmaceuticals (and distributed by Pharmaceucticals).

Unithroid was approved by the FDA as safe and effective in August of 2000.

In a recent letter from the FDA's Association Commissioner for Regulatory

Affairs, Dennis E.Baker, to representatives of Jerome s Pharmaceuticals,

the FDA has indicated: " At present, the August 14, 2001, deadline remains in

place, and FDA has no plans to extend the date by which levothyroxine sodium

products must have approved applications. " (1)

Jerome s has expanded its production capabilities in order to be in a

position to meret the entire U.S. demand for levothyroxine, should no other

products receive approvals in the next six months.

According to a press release issued by :

Many are unaware that levothyroxine sodium has a long history of stability,

potency, and consistency issues leading to recalls by the FDA. It is a

notoriously unstable compound and difficult to produce. Since 1991, there have

been at least 10 recalls of levothyroxine, involving 150 lots and 100 million

tablets.(2) Issues ranged from the tablets having less active ingredient than

indicated, to the failure of medication to maintain its potency through the

expiration date. In addition, because levothyroxine sodium was available prior

to the NDA approval process, it was not subject to the same strict regulations

as FDA-approved drugs with New Drug Applications (NDAs). Therefore,

manufacturers were able to reformulate the product, resulting in potency

fluctuations of up to 30%.(2) The potential for these issues to negatively

impact patients is vast. In addition, in a recent large- scale study, it was

shown that approximately 40% of the participants who were on thyroid hormone had

abnormal thyroid test results.

As a result of the problems stemming from levothyroxine sodium's inherent

instability, the FDA issued a mandate in August 1997 requiring that all

manufacturers of levothyroxine sodium have a complete and approved NDA filed by

August 2000 to continue marketing.(2) At the request of Knoll Pharmaceutical

Company, maker of Synthroid, the deadline was extended 1 year. Currently, the

deadline is set at August 2001. After that, any levothyroxine sodium product

without an NDA may be pulled from the market by the FDA.

To date, only the manufacturer of Unithroid has complied with the FDA mandate

and received NDA approval. This means that there is only one levothyroxine

sodium currently available that the FDA has approved as safe and effective,

having satisfactorily addressed all issues regarding stability, potency,

dissolution, and bioavailability. Pharmaceuticals, Inc. has recently

entered into an exclusive agreement with Jerome s Pharmaceuticals to

market Unithroid. Unithroid was previously produced under the names

levothyroxine sodium and Thyrox for more than 10 years, with 1 billion

tablets manufactured without a recall. Unithroid is now available by

prescription only, and can be found at your local pharmacy. Patients with

hypothyroidism should ask their physicians about their treatment options.

1. Letter from Dennis Baker, FDA, to Marc J. Schaineson, Esq.February 2, 2001

2. Department of Health and Human Services, Food and Drug Administration.

Prescription drug products; levothyroxine sodium. Federal Register. 1997;62.

Available at http://thyroid.about.com/blfdarpt.htm.

Contact Shomon

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At 10/15/01 05:40 PM, you wrote:

>My doc just changed me over to Unithroid. I have just gone off to

>prepare for my scan, so when I start up again, I'll go on the Unithroid

>instead. I was doing OK on the Synthroid, but the Unithroid is

>cheaper, though not all that much cheaper. Has anyone here had any

>experience with Unithroid? It seems to be more widely available now

>than previously.

>

>Bonnie, from Chicago

>pap 7/99, RAI 130 mCi 9/99 and 11/00, No clean scans yet, but I have

>my fingers crossed!

>