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Mary Shomon
Thyroid Disease Blog

By Mary Shomon, About.com Guide to Thyroid Disease

USP Announces a Revision to Levothyroxine Sodium Tablets

Thursday October 2, 2008
The requirements for the thyroid medication that most thyroid patients take are changing.

The USP (United States Pharmacopeia, the official public standards–setting authority for all prescription and over–the–counter medicines) has announced a change to the specification information -- known as the monograph -- for levothyroxine sodium tablets. Levothyroxine is the generic name for the thyroid hormone replacement drugs Synthroid, Levoxyl, Levothroid, and Unithroid, for example. The majority of patients taking thyroid hormone replacement are on a levothyroxine drug.

This change is being made to help ensure that levothyroxine retains its potency over its shelf life -- a problem that levothyroxine has had in the past, and continues to have. The current requirement is that each pill must contain "not less than 90.0 percent and not more than 110.0 percent of the labeled amount of levothyroxine sodium." The change is mandating that each pill will need to contain "not less than 95.0 percent and not more than 105.0 percent of the labeled amount of levothyroxine sodium" throughout their labeled shelf-lives. This change goes into effect October 3, 2009.

What does this mean for you?

This narrowing of the range of acceptable potency will reduce the amount of dosage fluctuation patients experience, and help stabilize thyroid function by providing a more stable dose. Right now, when you get a refill of your medication, if you get medication from a different manufacturer, you could go from a pill that is at 90% of potency, to one that is 110% of potency, or vice versa. Effectively, you've changed your dosage.

This latest development comes after the FDA's notification a year ago to all companies making levothyroxine sodium drug products, indicating that they would require that manufacturers meet the 95.0 percent to 105.0 percent range within 24 months. (You can read the letter the FDA sent to the drug manufacturers online.)

Photo: clipart.com

Comments
October 3, 2008 at 5:38 am
(1) Linda says:

That’s interesting. I live in England and I have found over the years that I need to keep to the same manufacturer. I wonder if that is why? Does anyone have any idea what the guidelines are in the UK?

October 3, 2008 at 5:43 am
(2) susan says:

i’ve never had the tablets with the same manufacturer ever since i’ve been on the tablets and never feel they’ve worked.

October 3, 2008 at 8:49 am
(3) Ali says:

This comment is for Susan, who mentioned that she has never felt that her meds were working. Susan, I took Synthroid for a year, on an adequate dosage, and never felt any better than when I started. I happened to read an article about Armour Thyroid, and begged my doctor to let me try it. What a difference. I’m a new woman! I feel so much better, and if you have a doctor that will treat your symptoms, along with using the Barnes Basal Temperature Test, instead of relying on lab tests, you’ll NEVER regret it! Good luck!!

October 3, 2008 at 9:28 am
(4) Emily says:

I started out on Synthroid, but its side effects made me switch to Levoxyl. Then my pharmacy gave me generic, which just wasn’t working and my endo said definitely go back to brand name. So I went back to regular Levoxyl with no problems. Incidentally they have identical co-pays!

October 3, 2008 at 9:35 am
(5) Karen says:

It makes sense finally! Up and down up and down! One would work, then it wouldn’t, etc. etc., etc.

October 3, 2008 at 9:42 am
(6) Linda says:

It’s about time! You can’t do thyroid panels to monitor levels yourself in between the 3 month or 6 month blood work. You have to relay on the drugs to do their job. I could tell something was up when I became tired a lot.
Kudos to the FDA!

October 5, 2008 at 5:16 pm
(7) Debby says:

I have had no luck with the generic version. I must stay on brand name due to constant change in my thyroid level. Insurance companies say there is no difference but there is. I am being penalized because of only being able to take synthroid. I hope some one in the insurance industry sees this.

October 5, 2008 at 5:47 pm
(8) nothyroid says:

Yet another reason to dump T4. You have to laugh at doctors who claim armour isn’t the same in each batch, yet their drug of choice is so crappy that the FDA constantly has to recall it, change it and watch the manufacturers because it’s not consistent. This the definition of insanity, isn’t it? Doing the same thing over and over again while hoping for different results.

October 6, 2008 at 4:52 am
(9) Sharry says:

Why can pharmacies no longer keep Armour Thyroid in stock? For the first time in five years (no joke), my thyroid levels are within normal range…ALL of them. But this didn’t occur until I was taken off synthetic thyroid HRT and placed on Armour. I am just 3 weeks into the “normal” range and now I cannot get Armour from ANY of my local pharmacies because it’s on “back order and we don’t know when we’ll be getting more. The manufacturer doesn’t know.” Folks, that’s verbatim and coming from pharmacists at Walgreens and CVS drugstores: the largest and most common in St. Petersburg, Florida.

A CVS pharmacist told me that “they are reformulating it.” Exact quote. Reformulating “what”? Armour is a natural thyroid hormone obtained from pigs.

So, what’s up, Forest? What is going on with the Armour Thyroid supply?

October 7, 2008 at 3:33 pm
(10) HOPE says:

AM TAking Altroxin but i don’t know if am having the right medication, am suffering from thyroid gland since 5 years but actually i didn’t find great changes as the doctor was excpected to me ,,, never losing weight and feeling depressed all the time and nedd to stay alone,, should i take another medicine oe supplement or it is normal to stay as am now!!!!!! plz anyone know something to tell me :(

October 7, 2008 at 9:45 pm
(11) Keri says:

I had my thyroid removed in 1999. I also went to my doctor and asked to placed on Armour Thyroid. I felt great!!! It was the best thyroid med I have experienced. I find it disturbing that the maker of it can’t keep it on the shelves. I now had to go back to another medication that doesn’t work as well. I think they need to work harder so that we can all start feeling better.

October 10, 2008 at 1:07 pm
(12) Valerie says:

I had my thyroid removed a little over a year now. I have gained weight, my hair is as dry as the desert, I’m tired most of the time especially when I’m not drinking caffeine, and have difficulty concentrating like I’m in a fog. I’m not a couch potato…I have a teenage son to keep up with and I try to work out at least 4 to 5 days a week. I’ve been taking Levoxyl the whole time and even asked the pharmacist to restrict my prescription to one manufacturer. Of course it’s the same thing…doctor says my levels are fine. What next? Is Armour Thyroid really that good?

October 21, 2008 at 8:57 am
(13) Leona says:

For those unable to get Armour Thyroid medicine consistently… About a year ago my pharmacy seemed to have difficulty getting the 1 grain tabs, so, when they got them, I asked my physician and I paid for it out of my pocket, to write a prescription for a supply in addition to my monthly supply, so I always have one month more than I need for those times when it is unavailable. The other thing you can do is ask the pharmacist (or your physician) to supply the same dose in a different strength for that month. I take 2-3 grains per day and have had them on occasion fill it with 1/2 grain (more pills, but they had them in stock). I’d rather have the Armour than get a substitute.

October 21, 2008 at 3:10 pm
(14) Tari says:

I have yet to find a medication that does not cause me terrible side effects. I’ve done everything from Synthroid to Armour and back again. Different doses don’t change anything. My bloodwork says the medication is supporting my thyroid but I feel just crappy, bad enough that I couldn’t work for two years.

Last year, I told my endocrinologist I’d had it and was stopping my medication. She argued with me and warned me but I went ahead with that decision anyway. Though my blood readings show I’m way off, I sleep at night and I’m productively back at work. I can even go shopping all afternoon without having to go back and sit in my car because I’m sick.

I’d love it if I could find a medication that would keep my blood levels where they need to be as well as letting me have a life. So far, for me, it’s been a no-go.

I’m new to this group. If this topic has been addressed, I apologize for my ignorance but if this change means I can be healthy and upright at the same time, I’m all for it!

October 21, 2008 at 6:34 pm
(15) Bonnie says:

Hope and Tari…

I have also switched to a natural thyroid and it made a big difference, not as many fluctuations – NO side effects. I also started taking a product called “Juice Plus” – 17 fruits and vegetables in capsule form. My edema went away and I am able to lose weight. Go to ‘rx4prevention.ca’ for more information.

I also went on Vitamin D. Do you find that your thyroid is worse in the winter? You finally lose a few pounds in the summer, then put it back again, plus 15 in the winter? Everyone needs to be on at least 2,000ml if you don’t live in a place where the sun is always shining, or if you wear a lot of clothes, or use sunscreen. Do some research on Vitamin D3 and you will be amazed!

I hope everyone well!

October 21, 2008 at 10:00 pm
(16) marcysg1 says:

Surprisingly enough, the last 2 mail-order pharmacies I’ve used will both give you SYNTHROID if your doctor writes a script saying Synthroid–Generic substitute permitted. Both companies have either received a terrific deal on synthroid OR they realize that having just ONE manufacturer benefits their clients.
Surprisingly–if you get the synthroid (as a brand name per the doctor’s script) you pay a BRAND drug fee. If you get the synthroid (as a generic per the doctor’s script) you pay the GENERIC fee.

This is with 2 different insurance companies AND 2 different mail-order pharmacies!

October 22, 2008 at 12:41 pm
(17) Renee says:

In response to Valerie:
I too had my thyroid remove a year ago. I had all the same symptoms as you. My doc did not seem to care. So I went to a new one. She explained everything to me and had me try a combination of medication for T4 AND T3. I am back to normal again! I am taking Synthroid and 5mg of Cytomel in the morning and again 5mg of Cytomel at lunch. My hair no longer is falling out, my skin is not painfully dry, and I have energy to enjoy life again. Talk to your doctor about taking a small dose of Cytomel. If he/she is not willing to listen and help you out get a different doctor who will!
Best wishes,
Renee

October 23, 2008 at 11:24 am
(18) Joanne says:

I have been diagnosed with Hashimotos. I have been on a compound of T-3 & T-4 and a formulated progesteron cream.
This is working for me, so if you
can find a compounding pharmacy you may find great results. Good luck to all. Joanne

November 1, 2008 at 5:22 pm
(19) Bonnie says:

Went to a Vitamin D Seminar with Dr. Bruce Hollis. The recommended daily allowance is actually 4,000! The best source is Carlson Labs ’solar gems’. Hope this helps everyone! I know it really helps me. I actually increased to 6,000 a week ago, the same recommended dose for pregnant and nursing women.

January 4, 2009 at 3:07 pm
(20) polygonum says:

Linda,

Only just saw your question. The same change is being made in the UK. Not sure if the deadline is the same or not but the 95 to 105% is being implemented. (I believe this is also happening in some other countries.)

Rod

July 3, 2009 at 7:15 am
(21) catherine jennifer/jentilpet says:

I told my dr. I wanted to swith to “Amourthyroid” since it has natural properties,& I am certain the 30lbs I gained IS INDEED from Synthroid!My instincts have always told me this,& unless people are devoid in their thinking that the dr. knows better than us,they have a bigger problem!”We know our body[ies] better than anyone!” Today’s times have given us an “assembly line” of prestigious driven college kids who are not becoming doctors because they want to “help” the human race!They’ll join the FDA,AMA,passing approvals for,then telling us “alternatives” ARE the ones we must watch out for! Yes,2 doctors actually said this to me!They were comparing the 10 side-effects from med’s from the perhaps one w/ natural?? There’s NO money$$$ in altern’s,remember,no insurance,& MD’s know nothing re: thyroid anyway!My dr. of 2yrs..just told me “that’s why I don’t like to write for Amourthyroid”[because it flucuates!{??} levels,that is? In other words he just changed the very issues Synthroid has!!Telling me the opposite of what we read above??I left his office w/ the understanding that he can do wahtever he feels he should,which I regret I said! So,does this mean, I’d need blood tests every 2weeks? 2 mon’s? when?I haven’t read this,not once!Is this beause he doesn’t want to be bothered w/ constant tests? Then again,what is his BIG job anyway…”I” am the one who would be going for tests,& who needs to leave the leave the house,then always worry if the levels are still stable?All he does is change mil’s to grains,if he knows how…write another script,big deal,what “explorations” will he need to give any intellectual thinking to?”i”..”we” do more on our computer than they do, I’ve seen their faces,”pained” look as if to say…”what were you saying?”What did you read?”Imagine this? Eastern Pa,is devoid of good doctors,unlike where I lived for 40yrs,Nassau County’s Manhassett Hosp/Biological/Disease…”these” are educated..not just college made stutents,acedemically,inept..look at those doctors who have killed Michael Jackson..yes,influence & money was all they needed “To Do Harm! Dr. Finkelstein,getting in his car was asked if he’d write or ever write cuch a dangerous drug..he said w/ a smug,big {Shot} persona-ego…even if I di, I wouldn’t tell you,whether “quoted’ or not,I’m sure he’ll not sue me!His smug,attitude was appauling[this was in the Indider/E.T!then the other dr. in question who wanted to RUN from the camera,bec- he might have put MJ under anestegia while he monitored him as he slept??And now they say “those doctors will NEVER answer for what they’ve been doing? It is not the street drugs as mucg as the dr’s who fill scrips!!Doesn’t matter what name they use..the fact that the names ARE ficticious,still& maybe worse…hold them accountable for his death especially the one they interviewed who wanted to run…cannot remember his name,but he;ll soon be center of this investigation..doctors have that “Code of Honor too!” they Enable,when they cover each other!God..knows what a price tag MJ put on that IF he did!!Toxicology will tell…
So please tell me does Amourthyroid have all of these level issues?This is a natural med!!Not synthethio I tell him I want it anyway,? What & how many times CAN levels change,to that point,that he said “that’s why I don’t like to give that..” meanwhile it IS Synthroid that changes levels..more like from 175 to 150 in 1 year or less,there’s been many flucuations w/ SIN-Thyroid..he’s a liar!

November 14, 2009 at 11:17 pm
(22) Laura says:

Does anyone know if the change went into effect?

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