Subpotent?!?

My bout of a worsening of my hypothyroidism might not have anything to do with my thyroid falling apart more. I had been on a mission to figure out what had triggered this bout – after having been stable for almost four years. Although stress might have been the original trigger, maybe this time it’s something else that triggered the worsening of my hypothyroidism. After my doctor called in a script at a higher dosage, the pharmacist called me because he couldn’t fill it. Even the wholesaler was out. That seemed odd, so i did some research. Here’s what i found.

A recent earnings report by Forest Lab included this [my comments in square brackets]:

Separately, Forest distributes Levothroid, a synthetic levothyroxine product for the treatment of hypothyroidism [the brand i was taking], pursuant to a distribution agreement with the product’s manufacturer and holder of the product’s NDA [that's Lloyd Pharmaceuticals]. The manufacturer has notified Forest that the FDA has indicated it has regulatory and quality concerns with respect to the facility where the product is manufactured. The manufacturer has stopped manufacturing and shipping product from its facility. At this time, Forest understands that the manufacturer is continuing to work with the FDA to address the FDA’s concerns.

Pending further details Forest has discontinued shipping Levothroid to its customers and does not know how long the product will be unavailable.

Although i was unable to find the actual FDA letter, i found a couple of enforcement reports that outlined recalls of Levothroid, the medication i was taking, at 75 mcg and at 50 mcg, though these weren’t the strengths i was taking. They found them to be subpotent! Between these recalls, the distribution issues, and the FDA concerns, i realized that i might not have been taking what i thought i was! And this would fully explain the change in my condition: If the dosage was subpotent, it would explain the rise in my test results and the symptoms i’ve been struggling with.

To me this is an example of two things:

  1. It shows the lack of care drug manufacturers have. Forest (and the manufacturer Lloyd Pharmaceuticals) have been in trouble with the FDA before, quite a bit actually. They don’t seem to care how this is impacting people’s health and quality of life.
  2. I forget about the systemic issues! I looked for answers that would explain why my hypothyroidism got triggered through something i did (or didn’t do). It didn’t even occur to me that the medication i was taking could be subpotent.

To me, it’s another lesson to remember to look at the systems, including those outside of my personal influence. And it’s time to switch medication!






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Subpotent?!? — 21 Comments

  1. I already been through several thyroid medications and all seem to leave me feeling horrible including armor. I was on Levothroid for 16 yrs never having the issues im dealing w today. I dont know what to take or just get off any medications for thyroid. Im stuck!!!!

    • Obviously, I don’t know your situation – though I can so relate to your suffering and frustration – and I want to share what has helped me in case it might help you. First, I switched doctors when I kept dragging! I was at an HMO and finally demanded to see a specialist who tripled (!) my dosage but even that wasn’t enough. So, I left the HMO and found an MD who added some herbal support to the thyroid meds. Let me see if I can find the name of the supplement… More recently, I’ve started eating two Brazil nuts per day, which have enough selenium to function as a thyroid support. Finally, it turns out that there were a few other things that contributed to my fatigue: Allergies and lack of Vitamin D. So, if you can, try finding a doctor who is willing to look into your treatment from all sorts of angles, including herbal support and other things that might be behind your symptoms. Wishing you lots of luck!!! It sucks to feel stuck!!!

  2. Hi all,

    This information is so helpful! I recently went through the same thing being switched from Levothroid (I was at 88mcg and was being switched to 100mcg when the pharm said it was no longer available)to Synthroid. Not only did I go through a few months of hypo symptoms (BAD! for the first time in years!) prior to the increase and switch, but here I am less than a few months later sweating like crazy, shaking, unable to sleep, irritable as can be!! Hypo to hyper in less than 4 months!!! My guess, based on this information, is that I could have been taking subpotent Levothroid and am now “over the edge” from the bounce back with Synthroid. I’ll be getting labs done in a few weeks, but in the meantime, I’ve been struggling with the emotional and psychological impact while the Doc says “just give it a few more weeks!!!” Not to mention, I just started dating a new guy when all of this started and have been a roller-coaster of a human being when I am normally a “glass-half-full-live-the-life-you-love” kinda gal. I thank god he sent me this patient and kind man! Is anyone doing anything to let the manufacturers/distributers know this is unacceptable?

    • Oh, wow, Melissa! This is so frustrating! I wish you a speedy rebalancing!

      I have considered suing the manufacturer when I felt particularly miserable but dismissed it because I spent too much time already mired in divorce-related legal struggles… Plus, I don’t even know if there’d be enough for a class-action suit…

  3. I’ve been feeling like I was going crazy for years with symptoms swinging from anxiety (too much medication) to depression (too little medication), mental foggyness, difficulty finding words, difficulty sleeping, joint stiffness, erratic periods etc. I suspect my Levothroid .112 mg has been dosed at irregular levels for a long time. I’ve been on brand name Synthroid now for 3 months and I’m starting to finally feel like my old self again. It’s been a blessing for me that Levothroid was finally recalled, but why did it take so long! I will never go back. I also had a bad reaction years past to another generic so beware, the additives can cause allergic reactions.

  4. I, too, have had to switch from Levothroid to Levothyroxin. I have been feeling really “yucky” and “foggy” and also have had red, blistering, peeling around my lips. THIS is when I started my research. I am wondering if I am sensitive to synthetic drugs, as I know I was to another. Very frustrating!!

  5. The only worry I had with Levoxyl, it seemed unstable too.. and people complaining it dissovles to fast in the throat. Levothroid is brand, so is Levoxyl. They all seem to have different fillers and varient is strenght. Even though they all say they are equal. I can definitly say Synthroid is far stronger in dosage versus levothroid.

  6. Check out an article by Mary Shomon from 2001 on Synthroid:

    Synthroid has a long history of manufacturing problems, subpotency concerns, and stability and reliability issues, says a letter sent to Synthroid’s manufacturer from the FDA, and just released to the public.

    So, clearly, a brand can also have subpotency problems…

    I am taking Levoxyl now and am hoping they haven’t received a letter like this, too!

  7. Levothroid has multiple manufacturers–it’s just the Lloyd Pharmaceuticals one that was recalled. In my case, my health system dropped that one and picked up a different manufacturer’s version. That said, switching to Synthroid is probably fine…but perhaps more expensive. I’d question why your doctor would knee-jerk away from all generics because of the quality-control problems at one manufacturer. That problem could happen with a brand-name drug too, couldn’t it?

    • As far as i know Levothroid is a brand, not a generic… And if you look at recall histories, there are several brands that have recalls, though, again as far as i know, not as broad as Levothroid’s – Lloyd stopped manufacturing period, not just a certain dosage.

      And Synthroid is the priciest brand out there… Not surprisingly, Abbott Labs tried to suppress some research that indicated that for most people generics are just fine (see an older post of mine for details. So, unless you know that you are very sensitive to the dosage amount (as i seem to be), there is no reason not to go with generics, which might have a higher dosage variability than brands do.

  8. I just found out my 125 mcg Levothroid was recalled when I went to get a refill and only have a few pills left. I’m SO frustrated that neither my doctor nor pharmacy called to tell me that the drug would be gone from every pharmacy in town. I too have been feeling yucky for the past few months and suspected my dosage was off. So, has anyone had success with Synthroid? My doc is super adamant that I don’t take a generic.

  9. I’m not sure I like synthroid yet, 150 was soo strong I’m assuming it is because Levothroid was probably less potent or not at all. Who knows. I was debating if I should try Levoxyl. But I might have the same issue. I’m on several Thyroid boards and no one seems to talk about Levothroid or difficulities switching. Maybe most people are on synthroid or generic.

    I have not found much info on the recall. By the time it returns to the market I will be adjusted to new meds and will not likely switch back.

  10. As far as I know it is still recalled. I was on 150 levo for 10 years doing fine until a couple of months my TSH went to 3.7. I’m switching to synthroid having a hard time adjusting. It seems a lot stronger. Let me know what everyone switched to?

    • Thanks, Natalie, for sharing your experience… I switched to Levoxyl mid-July and ended up hypErthyroid, though that probably was because my MD didn’t believe me about the subpotency.

      I could only find two official recall notices from the FDA, neither at the strength i was taking, links are in my original post… Do you have any other info that we could share here? I did file a report with the FDA on the two strengths i was taking (125 mcg and 137 mcg) since i suspect that the versions i took earlier this year were subpotent (i had been on 125 mcg for 4 years with changes in TSH…)

  11. I have been on Levothroid (100MCG) for 28 years for a growth on my thyroid. I am wondering how this affects me? I just found out about this recall when I went to renew my perscription. Any information you can give me would be appreciated.

    • Chris: I would recommend talking with your doctor about switching you to a different brand because there’s no way to tell how long it might take for Lloyd to start producing again. Based on some research i did a couple years ago Levoxyl is the next least expensive one…

  12. Rachel, thanks for your post. Which manufacturer(s) are you–and JT, if you happen to know–getting your levothroid from? Also, do you know the brand name? Can’t thank you enough! Katy

    • Katy: As i mentioned in the post, the manufacturer of Levothroid is Lloyd Pharmaceuticals. Forest Labs destribute it. Levothroid is the brandname for this particular form of levothyroxine… I hope this helps!

  13. Pingback: Loneliness | Rachel's Musings

  14. Thank you so much for posting this. I just got a letter from my health system, telling me they were replacing Forest’s levothyroxine with a different manufacturer’s. I’ve been adjusting my dose with my doctor for the last eight weeks because my symptoms (and my TSH/free T4) have gone haywire recently. This could explain all of it.

    I also never considered that my symptoms could be the result of subpar manufacturing practices by the manufacturer of my medication. Why should we have to consider this?

    • Thank you, JT, for your comment! Sounds like you’ve gone through the same stuff i have… Let’s hope that the manufacturers we’re getting our new meds from have better quality control than i am guessing Lloyd had…

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