Svær sak-FDA vil tvinge fram en NDA for Armour etc--hele nettet er fullt av meldinger

[nora]

Mer sladder:

http://forums.about.com/n/pfx/forum....roid&tid=88521

" Scarlett W * Posted: Sep 12 09 12:11 PM Message: 88521.29 (29 of 49) * Reply to 88521.19

Dr. Berndtson,

I just placed an order for dessicated thyroid 60mg tablets with Erfa Canada. I spoke with Dr. Henri Knafo, the Medical Director of Erfa Canada, on Thursday morning. I followed the steps outlined here:

http://thyroid.erfa.net/index.php/en...of-canada.html

My physician faxed the prescription and the FDA form 1572 to Erfa earlier today (Friday). I just now placed the order at

http://www.pharmasourcing.com/cmdall...eg=P&langue=en

There was no place to enter credit card information so I guess I am going to be billed as I was asked for a billing address. Dr. Knafo told me that I needed to order as quickly as possible because erfa has been inundated by callers from the USA and will soon no longer have a supply available (at least temporarily). He said that one physician from the USA called him and wanted to buy the entire Erfa supply for his patients.

Dr. Knafo also said that Erfa is planning to do a two year study of their thyroid product and that all USA patients obtaining the drug from them would become study patients so that they could continue to be supplied during that time and that then Erfa will file an NDA with the FDA.

Another thing that Dr. Knafo mentioned is that the FDA form 1572 is no longer required as Erfa has hired someone who will fill it out there so if USA physicians do not want to fill that out the patient can still get the drug as long as they have a supply. He also said that it is his opinion that Armour will never return to the market which is an opinion I share.

The shipping and handling seems a bit high ($30) for one bottle of 500 60mg tablets at $70 (8 month supply), but I am very happy that I could get this at all.

I too share a concern about the ability of compounding pharmacies to duplicate well manufactured, standardized natural thyroid extracts. I have also had my physician place an order with a compounding pharmacy here in Hawaii (which began compounding two weeks ago in all but the highest doses) but I did not want to have only a supply from a compounding pharmacy.

I have been on Armour for 51 years (thyroid carcinoma at 15) and did not get any of the reformulated Armour until last week when I could only get a 7 day supply. (I was blissfully unaware of this entire mess until last week). I tried Synthroid around 1990-91 at the urging of an endocrinologist who said that Armour would cause osteoporosis. It was a horrible experience as blood tests at two months showed my T3 to be very low and T4 also below normal and I had many hypo symptoms. I felt as though another person was living in my skin instead of me. My family physican who has known me for many, many years took one look at me and, even before the blood test results came back, put me back on Armour.

I am now leery of the reformulated Armour even if it were available currently and am very glad I could obtain the Canadian product (which Dr. Knafo says stinks, as it should, as opposed to the reformulated Armour which has almost no odor). Dr. Knafo said that he does not blame the FDA in regards to their action against Armour because the reformulated product was making too many patients sick.

"
Sjekk også maryHs kommentar til dette:
" * To: ScarlettW_ * Posted: Sep 12 09 06:12 PM * Message:
* 88521.31 (31 of 49) * Reply to 88521.29

Looks like Erfa may be working on an IND - investigational new drug application - for their thyrod. That's a major preparatory step that is taken before an NDA is submitted.

Just a general caution should you decide to go this route. Please make certain that your doc reads the back of the FDA Form 1572 and checks one of the two boxes at the top. I used to have to review these forms when I worked at Pfizer, and the lack of a check mark in Box 8 (I think it is) was the number one problem I found. Also, please have your doc complete the 1572 and sign it. Or, if the Erfa person completes the form, your doc must sign it. 1572s are tricky forms but FDA takes them very seriously.
"
" * To: MaryH * Posted: Sep 17 09 11:38 AM * Message:
* 88521.32 (32 of 49) * Reply to 88521.31

Hi MaryH,

I just got my order from Erfa today! It was shipped Monday via FedX 2nd day air and I got it Wednesday afternoon and I had to sign for it.

It came in a HUGE box and the bottom of the box had a Homeland Security tape around it. The odd thing was that on the top of the outside of the box was a very large clear plastic packet of information including a copy of my doctor's FDA form 1572, his curriculum vitae, the prescription, 12 pages of Prescribing information and a bunch of other information...18 pages in all and Homeland Security did not open that. There was a SECOND set of the papers inside the box so I guess they looked through those. The small bottle in this huge box was stuck in one corner with a lot of crumpled paper taking up the rest of the box as filler. The bottle was very warm to the touch. I hope it wasn't in the back of the FedX enclosed truck for very long as temperatures reach 140 degrees Fahrenheit back there. With 18 pages of information in the box, as well as on the top, the box could have been real small but that one was still way too large but then a little box might have more chance of getting lost. I prefer USPS simply because they have open carts so the packages are not subjected to the high heat that UPS and FedX have with their enclosed trucks.
"
Ja, har lest det før, at erfa skal søke NDA i USA og da blir de de eneste som har et godkjent produkt. Forest vil ikke gjøre det, og heller ikke søke godkjenning i Europa. De har jo ikke rettigheter utenfor USA så de kan ikke heller.
Bruk erfa.

[Sonja Midtlien]

Svar fra Nycomed:

Takk for henvendelsen. Vi har ikke forandret noe på Levaxin tabletten. Den er også helt lik som da den het Thyroxin.

Ragnhild T. Scheen

farmasøyt, Nycomed informasjon

Så da vet vi det.

[nora]

Jeg har ikke merket noe med levaxinen, er for meg lik thyroxin som det het før. Tror ikke jeg hørte om noen som merket forskjell, men det var spørsmål om det dengang.
Det er alltid noen som får bivirkninger/manglende effekt ved selv små forandringer av fyllstoffene....så det kan alltid hende.

[nora]

Mary Shomon postet i en liten kommentar idag at hun hørte at en lege hadde hørt at Armour Thyroid ikke kommer tilbake.
Det er tilfeldigvis samme som erfa (Knafo) sier på forumet sitt.

[Anisa]

Bestillingen er sendt til Tyskland i går. Med tysk punktlighet og ryddighet regner jeg med at det ankommer snart

Det håber jeg snart sker, Rufus

I deres svar til mig skrev de d. 30.09.2009: "Das Medikament können wir für Sie bestellen; es dauert ca. 14-18 Tage bis es bei uns ist." Jeg tror derfor, at Erfa Thyroid er ikke en lagervare, men skaffes frem til hver bestilling, hvorfor det vil tage 14-18 dage inden de kan afsende medicinen til modtageren.

[Rufus]

Jeg tror derfor, at Erfa Thyroid er ikke en lagervare, men skaffes frem til hver bestilling, hvorfor det vil tage 14-18 dage inden de kan afsende medicinen til modtageren.

Ok, da er nok det grunnen til at det ikke har skjedd noe ennå - 18 dager etter at jeg sendte bestillingen. Jeg sendte dem en epost for noen dager siden for å forsikre meg om at de hadde mottatt bestillingen, resepten og de nødvendige opplysningene. Det hadde de visst, og skrev videre: "we are processing your order" uten at jeg ble spesielt mye klokere av det. Da håper jeg det kommer i løpet av neste uke. Er jo snart tom for medisin også.

[Hansen]

Ikke godt å si hva dette skyldes. Ofte er det en masse lover og regler som kompliserer, øker den allmenne forbannelse og komiserer.

I Norge har feks. Apotekene ikke lov til å ha Armour på lager. Heller ikke om Apoteket vil øke sin service til faste registrerte kunder.
Man kan altså ikke få utlevert medisinen med det samme.
Det går ikke mer enn en dag eller to så kan man hente sin bestilling.
Men vi Normenn finner oss i det - det er bare slik, sådaså..............

Det er vel en regel som kun er egnet til å forvanske bruk av Thyriod i forhold til Syntroid - og jeg vil jo tro det skal bli vanskelig å opprettholde slike konkuransevridende tiltak - også innen denne sektoren.

Er det noen som vet hvor og hvordan man anmelder slike forhold ?

[Vigdis]

Hva med pasientombudet, n`Finn?

Vi skal ikke finne oss i ting!

[Hansen]

Det skal jeg da jammen forsøke Ruth !
Skal bli spennende å høre svaret.....

[Vigdis]

Vær med og skriv under til støtte for bevarelsen av naturlig tyroksin! Du trenger ikke bo i USA for å skrive under (velg land i undeskriftbrevet) Du finner det her

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