Aa
NEWS FLASH on the shortage of desiccated thyroid meds.
Here is the information I received today from both RLC labs ( the makers of Naturethroid) and the FDA.
YES!!! - I really talked to a live person with both of them:)
Now remember - this is ONLY the most up to date information I have. It sounded a bit hairy on the phone with the FDA - but I'll explain below.
First - both organizations were the best people I have spoken to in a long time.
1. RLC labs....... "There is NO ceasing of desiccated thyroid medication. The FDA is not shutting us down." end quote.
RLC labs has been under extreme "supply and demand" to make their product due to the change in Armour back in February. They reassured me that there is a 90 day supply delay and that production WILL meet the needs of all their new customers very soon.
NO REASON TO PANIC right ?????
2. FDA......... I spoke to a person named Ellen. Again very nice and informative. Unfortunately she was not able to foresee any decision on the FDA bringing an end to desiccated thyroid. BUT- here is basically what she told me.
Because of the Armour CHANGE without FDA notification back in February, the FDA has decided to examine the claus that "grandfathered" Armour thyroid into the FDA back in the 70's. From how I gathered it - Because Forest Pharacuticals CHANGED Armour thyroid without going through the proper channels with the FDA - that brought their grandfather status to VOID and that is where the investigation is lying.
In addition to this and ALL the hooplah that other forums and media have proclaimed in the last few days, the FDA has gotten many calls by advocants of thyroid medication and have centered the attraction now on ALL DESICCATED thyroid medication and labs to fall under the political examining knife.
Way to go.... :( This is the gray area and the wait for the actual FDA statement... that's coming soon.
SO now - presently , I want to give you a website that - if you're concerned and want to stay completely informed on IF - the FDA - WILL decide to cease production of all desiccated thyroid medication. You can go to the actual website of the FDA called
www.fda.org.
That site is the most credible way to get ALL the information we need. I doubt they will refuse to post anything like a cease of a drug without willingly knowing they would be held accountable with a class action lawsuit by the public almost immediately. Especially with the way the internet keeps us up to speed!
Relax... don't stress..... I took the entire day off from my job - ( NO PAY) on this whole crazy situation and I firmly believe there is no reason to be worried. I was sucked in hard by it too. I was.....Scared to death.
After the numerous calls I made all over the place - regardless of even IF a cease of drugs was done. There are still plenty of options for desiccated thyroid patients to be able to get their meds. I stand behind what I found out today!
YES!!! - I really talked to a live person with both of them:)
Now remember - this is ONLY the most up to date information I have. It sounded a bit hairy on the phone with the FDA - but I'll explain below.
First - both organizations were the best people I have spoken to in a long time.
1. RLC labs....... "There is NO ceasing of desiccated thyroid medication. The FDA is not shutting us down." end quote.
RLC labs has been under extreme "supply and demand" to make their product due to the change in Armour back in February. They reassured me that there is a 90 day supply delay and that production WILL meet the needs of all their new customers very soon.
NO REASON TO PANIC right ?????
2. FDA......... I spoke to a person named Ellen. Again very nice and informative. Unfortunately she was not able to foresee any decision on the FDA bringing an end to desiccated thyroid. BUT- here is basically what she told me.
Because of the Armour CHANGE without FDA notification back in February, the FDA has decided to examine the claus that "grandfathered" Armour thyroid into the FDA back in the 70's. From how I gathered it - Because Forest Pharacuticals CHANGED Armour thyroid without going through the proper channels with the FDA - that brought their grandfather status to VOID and that is where the investigation is lying.
In addition to this and ALL the hooplah that other forums and media have proclaimed in the last few days, the FDA has gotten many calls by advocants of thyroid medication and have centered the attraction now on ALL DESICCATED thyroid medication and labs to fall under the political examining knife.
Way to go.... :( This is the gray area and the wait for the actual FDA statement... that's coming soon.
SO now - presently , I want to give you a website that - if you're concerned and want to stay completely informed on IF - the FDA - WILL decide to cease production of all desiccated thyroid medication. You can go to the actual website of the FDA called
www.fda.org.
That site is the most credible way to get ALL the information we need. I doubt they will refuse to post anything like a cease of a drug without willingly knowing they would be held accountable with a class action lawsuit by the public almost immediately. Especially with the way the internet keeps us up to speed!
Relax... don't stress..... I took the entire day off from my job - ( NO PAY) on this whole crazy situation and I firmly believe there is no reason to be worried. I was sucked in hard by it too. I was.....Scared to death.
After the numerous calls I made all over the place - regardless of even IF a cease of drugs was done. There are still plenty of options for desiccated thyroid patients to be able to get their meds. I stand behind what I found out today!
I also talked to a pharmacist about the Melamine rumor and he said "NO WAY" that could happen. However, "something" did change suddenly for us after our last refill. I have the lab slips and my daughter has the sudden joint aches to prove it!
"Armour changed their ingredients due to the fact that Melamine was found in imports of desiccated thyroid from China."
Where did you get that information? That is NOT accurate according to Armour. The FDA also said they had no information regarding melamine in Armour, and they are the agency that monitors that. Let's not start rumors here, but if you do have something, please post the proof. I searched online all day and found nothing on that. A friend who works in the pharm industry, said the formulation change was more likely due to try to cut costs since most of the industry profits are down and they are worried that legislation might pass to make drug prices lower for us and for us able to ship from other countries might pass.
Where did you get that information? That is NOT accurate according to Armour. The FDA also said they had no information regarding melamine in Armour, and they are the agency that monitors that. Let's not start rumors here, but if you do have something, please post the proof. I searched online all day and found nothing on that. A friend who works in the pharm industry, said the formulation change was more likely due to try to cut costs since most of the industry profits are down and they are worried that legislation might pass to make drug prices lower for us and for us able to ship from other countries might pass.
Nothing posted on the FDA site. Here's a good link to current FDA Press Releases:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
C~
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
C~
I'll take a look tonight when I get home Stella.....presently laying on the lounge floor in the country with my laptop and signal strength not too good lol.
Does anyone have information on a press release from the FDA today? I can not find anything on the FDA site.
Thanks for all your continuing efforts for the benefit of all of us on the Forum. We appreciate it every single day.
Oh .... yes, of course .. remember those plates from the 60's .. didn't almost every kitchen have a set of those "new" plastic dishes made from the stuff?! Thanks. I do recall the pet deaths with kidney failure. Geez.
C~
C~
It's the same stuff that turned up in pet food from China a while back and was killing animals. It's also what those lovely plastic plates you take camping with you are made of. If your kitchen cabinets are lined in a factory-finished hard plastic...melamine, too. Really, really cheap filler???
Armour changed their ingredients due to the fact that Melamine was found in imports of desiccated thyroid from China.
Stella, we cannot thank you enough for this updated information. I, too, spent the afternoon behind the scenes doing much-needed research and wondered what was going on since nothing was formally posted on the FDA website. So, thanks for all your persistence getting thru to the right people and sharing the info with us all!
ChitChatNIne
ChitChatNIne
Thank you Ms. Stella!
From, Your little thyroidless Princess!!!
PS. please read mom's post to tracey123
From, Your little thyroidless Princess!!!
PS. please read mom's post to tracey123
Of course... if Armour... as I speculate.. wouldn't of rocked the boat changing that wonderful thyroid drug they had... none of this may not EVEN be an issue.
Again... way to go Forest! You rock :(
Again... way to go Forest! You rock :(
OK - now the ACTUAL reason why Major and Time Caps were told to cease production was due to them establishing themselves AFTER the 1962 “Drug Efficacy Amendment”, also called the Kefauver Harris Amendment proclaimed by the FDA. Being them as a NEW company, that is a different issue than RLC and Forest whom have been producing desiccated thyroid hormone medication WAY before that Amendment.
WHEW... I'm really tired. This was hard work today... I hope some of your questions have been answered.
WHEW... I'm really tired. This was hard work today... I hope some of your questions have been answered.
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