Not sure what to make of this. Most of the symptoms mentioned are widely discussed and well known. Maybe not so much specially in relation to Acella, but regarding any source of T4 and/or T3.
Something rather suggests to me it could be a bit of a try-it-on case.
Regardless the merits, the simple fact that there is a case might impact on the availability of Acella, and possibly other desiccated thyroid products, in both the short- and long-terms.
Patricia Vosburgh filed suit against Acella Pharmaceuticals, LLC and Walgreen Co. on Wednesday in the Middle District of Florida. The complaint was filed for an alleged personal injury on behalf of Vosburgh, who used Acella’s “dangerously defective” prescription drug, NP Thyroid. The drug is intended to treat hypothyroidism by either replacing or supplementing the thyroid hormone.
Vosburgh emphasizes that the prescription lacks a warning to patients, the healthcare community, and the medical community of the harmful effects that accompany the drug. The risks, as told by the plaintiff, include “improper dosage and/or excessive levels of liothyronine and levothyroxine,” each of which come with a host of side effects. Vosburgh also alleges that the defendants failed to disclose the link between NP Thyroid and atrial fibrillation, hypertension, chest pain, rapid heart rate/heart rhythm disturbances, weight loss, heat intolerance, fatigue, muscle weakness, and negative maternal and fetal outcomes such as miscarriage and impairment to fetal development.
The complaint details three instances in which Acella was forced to issue a nationwide recall of the disputed drug. The U.S. Food and Drug Administration announced in May of 2020 that defendant Acella would be issuing a “voluntary nationwide recall” of NP Thyroid because of superpotency, or high levels of liothyronine. Another recall was issued four months later due to sub-potency. April of 2021 marked another recall, when certain lots of NP Thyroid were found to have “less than 90% of the active ingredients liothyronine and/or levothyroxine as claimed on the bottle labels.”
NP Thyroid was distributed absent FDA approval or a valid biologics license. Vosburgh is suing the defendants for personal injuries based on the “sale, design, manufacture, testing, marketing, labeling, packaging, handling, distribution, storage, and/or sale of NP Thyroid.” The complaint includes two counts of strict product liability, negligence, and breach of express and implied warranty. Vosburgh is seeking a trial by jury, favorable judgement on all counts, compensatory, statutory, and economic damages, and any other relief that the plaintiff may be legally or equitably entitled to.
This worries me, especially seeing the case is being brought in a country which is famously litigious. How many others will jump on the bandwagon? It also plays into the hands of those in the medical profession who have warned us for ever of the supposed side effects..Somehow I smell a rat, but maybe I’m becoming paranoid having seen my last two saviours (Dr Skinner & Dr Myhill) hounded….
Even my NHS Endocrinologist acknowledges my levels are very stable and good on NDT, so I am very worried about this. I so wish WP and Nature Throid were back on the market.
Acella do make very clear warnings that any issues which occur need to be investigated. A lot more comprehensively than many levothyroxine producers.
Of course, if doctors and patients don't read it, the manufacturer is hardly to blame.
INFORMATION FOR PATIENTS
Information for the Patient—Patients on thyroid hormone preparations and parents of children on thyroid therapy should be informed that: 1. Replacement therapy is to be taken essentially for life, with the exception of cases of transient hypothyroidism, usually associated with thyroiditis, and in those patients receiving a therapeutic trial of the drug. 2. They should immediately report during the course of therapy any signs or symptoms of thyroid hormone toxicity, e.g., chest pain, increased pulse rate, palpitations, excessive sweating, heat intolerance, nervousness, or any other unusual event. 3. In case of concomitant diabetes mellitus, the daily dosage of antidiabetic medication may need readjustment as thyroid hormone replacement is achieved. If thyroid medication is stopped, a downward readjustment of the dosage of insulin or oral hypoglycemic agent may be necessary to avoid hypoglycemia. At all times, close monitoring of urinary glucose levels is mandatory in such patients. 4. In case of concomitant oral anticoagulant therapy, the prothrombin time should be measured frequently to determine if the dosage of oral anticoagulants is to be readjusted. 5. Partial loss of hair may be experienced by children in the first few months of thyroid therapy, but this is usually a transient phenomenon and later recovery is usually the rule.
If Walgreen's didn't issue the pamphlet with the medication, then Walgreen's can be liablebut not the manufacturer based on the material you provided.
In Canada, Shoppers Drug Mart is one of the biggest if not the biggest of the drugstores. With each vial of medication they provide information about the drug on full size sheets of paper. But my neighbourhood drug store does not. I have to ask that my thyroxine be given in its original bottle or they put the pills in a clear vial. Dumb. Thyroxine is light sensitive. Or at least that's what I learned from taking it back in the 80s when it was in an amber glass bottle.
If Walgreens isn't doing what they should then they leave themselves open to this sort of legal action. Aside from that Walgreens appears to be having all manner of adverse publicity from charging orders of magnitude more than Costco, to having their computer security leaking data to customers about other customers, etc.
Most of the time, most medicines are pre-packed and include the appropriate Patient Information Leaflet.
If they have to split packs or dispense from bulk, then the issuing of PILs can go by the wayside. Though everyone is entitled to copies of the PILs it depends on individuals requesting them.
The huge exception is medicines dispensed in dosette packs - where PILs, etc., are pretty much never issued.
The lack of batch numbers and expiry dates is also an issue.
I had been advised by a medical specialist who is also taking thyroxine to always get the original bottle so I can see the expiration date. They give it to me with the original foil seal. It's a bit of a PITA to knock out the desiccant bullet...
The bottle contains 90 tablets. I remove the bullet when I open the bottle because it gets in the way of getting tablets out. Moisture in the atmosphere should not be a major issue given it is only 90 tablets. And I don't keep it in a place where there can be high humidity. (kitchen or bathroom)
Oh well, there's absolutely nothing a person can do about that. I bet there's phthalates too..................... That's the latest: phthalates are killing us.
i remember reading something suggesting changes in regulations would make it too expensive /technically difficult for the smaller manufacturers to re-register their products... leaving a monopoly for armour ... ?it might have been this ? maryshomon.medium.com/whats...
Yes, I can see the smaller companies producing and selling NDT being forced out of business. The big boys will do whatever they can do to get the smaller companies out of business I would think. They want to be the only supplier, they will be raking it in even more, it is common sense. Greed!
The losers will be the small companies of course, but also the people who can't afford to buy such things as Armour thyroid.
Is there anything in the States where they can stop the monopoly type thing going on between companies at all, never mind the pharma industry.
There haven't been many subsequent anti-trust actions resulting in breakups. Think IBM, Microsoft, Intel, facebook, etc., have all appeared possible targets.
Well I am worried because I am doing OK On Tiromel, but it isn't perfect and I would like to be able to trial NDT at some point after I have got this house move out of the way.
But I would never buy Armour, because if there cheaper alternatives that would be where I would start
Though Acella NP Thyroid does appear a little less expensive than Armour Thyroid, so far as I am aware that difference is more like 10% than a gigantic difference.
You have to go to Thyroid S to get a more sensibly priced product.
However, AbbVie, who are the current top-level owners of Armour, are gigantic beyond belief. Assets of something like 150 billion US dollars and revenue of 45 billion.
Abbvie have already chased WP Thyroid and Nature Throid off the market, and I have had to resort to Erfa. This has microcrystaline cellulose in it whch is not good for me, and Armour is even worse with Acacia Powder and Microcrystallinne cellulose. They might very well be better without these excipients. Life is getting very scarey and is definitely in the balance for me.
Do we have any proof that AbbVie were behind the FDA investigation of RCL's products (makers of Nature-Throid and WP Thyroid)?
I can perfectly well see that it is a possibility but, so far as I am aware, it remains feasible that Allergan and then AbbVie had nothing to do with it whatsoever.
I have vague memories of reading about dirty tricks from one or more companies in the past but I don't remember the story very well. What I remember is that pharma companies making NDT were supplied with "thyroid" powder that turned out (eventually) to be no such thing - it had no thyroid in it at all, it contained powder made from dried thymus gland. And this episode was one of the reasons given for declaring NDT to be unreliable. I think it had something to do with iodine levels as well, but I could have just made that up.
Can you remember the actual story?
...
The risks, as told by the plaintiff, include “improper dosage and/or excessive levels of liothyronine and levothyroxine,” each of which come with a host of side effects. Vosburgh also alleges that the defendants failed to disclose the link between NP Thyroid and atrial fibrillation, hypertension, chest pain, rapid heart rate/heart rhythm disturbances, weight loss, heat intolerance, fatigue, muscle weakness, and negative maternal and fetal outcomes such as miscarriage and impairment to fetal development.
This is utterly ridiculous. The description above mixes up the symptoms of hypothyroidism, over-medication for hypothyroidism, Hashi's flares, low and/or high cortisol, and also the symptoms of various nutrient deficiencies common in thyroid disease.
If the woman had a terrible doctor who never checked cortisol or nutrients or who monitored treatment by TSH only then the symptoms she had are probably not related to the Acella, but to the incompetence of her doctor.
Other patients often have to try multiple brands and multiple combinations of Levo, T3, and NDT before finding something that works. Some women only get pregnant on NDT. So this litigious woman Vosburgh, presumably with financial aid from one or more other pharma companies who want to get rid of NDT, is going to wreck the lives of millions of patients around the world (who are mostly women, of course), and she is going to throw all other patients under the bus and is hoping to profit by it to the tune of millions of dollars.
I want to do a lot of swearing but an emoji will have to do! 🤬🤬🤬🤬
Given our concerns, is anyone here in contact with the BTF? I don’t know how the US court system works in case like this but if BTF has a US equivalent it would be good to see them (or them joined with BTF) submit an amicus curiae in this case, to set the factual scene.
It occurred to me that we could write to Acella's lawyers and tell them to read thyroid forums like this one for info on the thyroid and why this women Vosburgh is going to destroy lots of lives. But how we find out who the lawyers are I haven't a clue. And would they listen to us anyway? Somehow I doubt it. *Sigh*
As Americans, we entrust our health and well-being to manufacturers and companies who design, build, and distribute products for use in our daily lives. Unfortunately, history has shown that certain companies choose to place profit over safety by selling defective products, dangerous devices, and harmful drugs. Even worse is when a company conceals or fails to warn about the dangers it knows to exist in their product.
We are investigating claims by people who have used these products:
Background: On April 30, 2021, Acella Pharmaceuticals voluntarily recalled 38 lots of NP Thyroid® (thyroid tablets, USP), in 100- and 7-count bottles, because testing found these lots to be subpotent. The product may have as low as 90% of the labeled amount of liothyronine (T3) and/or levothyroxine (T4).
So I bet the Vosburgh law suit has everything to do with this. Kick 'em when they are down strategy.
However, I don't know how much validity her claim will have given there was a voluntary recall. I guess it depends how long the pills were low content and how long it took for the company to issue the voluntary recall. She wouldn't have been the only person potentially adversely affected. So I guess once this goes the rounds on social media, there may be more people suing the company.
It would appear they have quality control issues. Their head office is in Georgia but it would be enlightening to find out where exactly the NP thyroid is produced. Are they getting the powdered hormone from somewhere outside of the USA?
Acella denied and denied any issues with quality starting in 2019. I used NP thyroid quite successfully for years, but I (and many others) started having a return of hypothyroid symptoms. We reported to them and the FDA and got no where from anyone. So we changed meds and symptoms resolved. Acella is absolutely culpable in this situation. Yes, I do think this plaintiff is probably just trying for a payday. Myself and others on the STTM forum (Stop The Thyroid Madness), reported pills that smelled like cat pee around the time things got worse. Acella said they were sourcing their porcine powder from Europe. Then much later they recalled their NDT.
I am also worried about the decline and demise of formerly great NDT products. I have been a complete replacement dose since 1988 due to RAI for Graves. I have been a victim of the “Synthyroid only” propaganda here in the states in the 80’s and 90’s, and finally realized I do not convert T4 to the usable T3 properly- so I truly need a good NDT!
No that was never disclosed, despite many of us trying to get a straight answer. We suspect the powder only came through Europe , from either China or South America, but have no proof. There is absolutely no transparency here in the States by pharmaceutical companies.
Would be most useful. I'd also like to throw the question at the Plaintiff, and Levo manufacturers as to whether Doctors are competent enough to treat Thyroid Patients, with whatever they are prescribing?
What is the name of the organisation who would have good grounds / standing to intervene? If not the BTF. I find all the thyroid organisations a bit hopeless - apologies for the massive generalisation - and low profile, given what a widespread and little understood problem thyroid conditions are. Apologies, apologies for my ignorance of any of their good work. I base this on what little I know of these organisations. Please do educate / tell us which thyroid organisations in the U.K. I should be more aware of or, indeed, how we can raise the low bar.
I can't think of any other than the patient organisations.
Desiccated thyroid has been so dismissed by most establishment medicine, for so long, few individuals know anything much about it.
Below is a link which shows this has been the case since at least forty years ago. Which covers the working lives of pretty much every practising doctor.
helvella - The end of Thyroid BP
A published letter which highlights the attitude regarding desiccated thyroid shortly before it was dropped from the British Pharmacopoeia.
Just thought to point out that if they (the plaintiff, or backers of the plaintiff, or whoever else is involved) successfully challenge Acella, and RLC fail to return to market, there would be just one product - Armour Thyroid.
If the change of status (to biologics) and fallout from this case cause issues, AbbVie could decide it isn't worth continuing with Armour.
Upshot - those who wish to continue taking desiccated thyroid will be left with Thailand (Thyroid S), Canada (ERFA) and, umm, that's about it in the big league. Plus glandulars with their unspecified and uncertain thyroid hormone content - quite possibly zero or excessive.
I wonder if Patricia Vosburgh would think that a good outcome?
If Armour was the only NDT left, then I would, reluctantly, go back to Levo, but not any from UK, as none are a patch on Goldshield Eltroxin. Would have to find a good T3 to go with it.
So much misunderstanding in that claim, it supplements OR replaces? Well, we know differently. But lawyers won't, even Acellas or Walgreens. I foresee BIG problems.
Hi thanks for sharing this article. I was about to do a post in regards to NP thyroid, because I've been getting side effects. If anyone can share with me if they changed thyroid meds recently and what they have switched over or if I need to do another post. I will do that. Thanks again
The NHS has taken Acella NP Thyroid off their ndt list because there is a variation of dose strength from 80% to 120%. A well know uk pharmacy's pharmacist told me this. In the UK you have a choice of just 2 NDTs now. Most have been removed. I have to say my experience of NP supports variation. I had to reduce my dose up and down depending on each pot of tablets. Now I'm on an approved uk one I dont need to do that anymore. Why this lady's thyroid wasnt better managed is another question of course! Lol...
So far as I can fathom, that is a much greater variation than the FDA have alleged.
I'd also like to know the methodoloigy used. After all, if that was done in a UK lab, we don't have any standards/protocols for measuring potency of desiccated thyroid products.
Interesting because the doctor I'm with now tells me this is why he does not support use of Thyroid S (which many swear by) . He doesn't recommend NP either and says the complaints and recall of Nature thyroid was wholly justified based on first hand experience and observation with his patients. Personally, ask around and even during the controversys with different NDTs there are people who remain happy taking them regardless, and it's absolutely awful for those people to have it taken away. I was fully recovering on NT even whilst it was supposedly underpowered and so far none of the others are resolving my issues half as well.
Only Armour and Erfa officially. He will support patients on a different NDT like Thyroid S (I'm on TS) or NP if they insist, but he says based on work with patients they have a wide variance in performance, he thinks they are unstable. He doesn't like any glandulars like Metavive or Threogland/Thyrogold (?) for similar reasons.
He reckons Armour is the best and most consistent overall. But what do you do if you don't take well to the only two that are 'endorsed' and all the alternatives have been put out of business or are too difficult to get hold of, and now even the private doctor you're paying £££ to won't write you a prescription?
I really don know! It really worries me. I was on NP but then they took it off the NHS list for huge variation. They are right as since I've been on Armour Ive been far more stable -no ups downs like on NP(....bloods were all over the place too..)..however my skin is much drier so I suspect am on too low a dose now. Waiting to do bloods then will see!
I tried Armour but I didnt get on with it well, couldn't sleep at all even on one grain a day and really wish I could, as it's far easier to get hold of and get prescribed even if it is more expensive. I do know you have to really persist sometimes and I hope you get to a good place with it and it all settles down.
Thanks. I was on Armour 10 years ago & it didn't suit me after they changed it made me poorly but really have little choice. Erfa made me very ill after they moved factory's and found it very variable..its all such a shame as ndt was a very good thyroid med. Hope you get sorted too.
Am sorry Helvella can't give u more info than what he told me. He told me it has been removed from NHS lists of meds for that reason so cant be prescribed on the NHS. Only two remaining are Armour & Erfa. It does worry me that the NHS is phasing out NDT meds but that's another matter. Again can't prove that either!!
However I will say this. Ive always been very stable on ndt meds with the same dose (full replacement) for years. Since going on Acella that did change and I ended up having to reduce by half a grain.....my blood tests showed over the range for T3 & T4.......but the dose need varied. So ended up putting up and down to try to accomodate. My doctor & I were a bit mystified by this. Since going onto Armour that has all gone & I've returned to my usual dose & am very stable once more. So am afraid this does seem to support the variation bring reported as being more extreme than usual for ndt treatment. Thats my personal experience.
Yes indeed.......but sadly there have been reports of these variations in levels for three years now with Acellas product. I never had th cat pee smell taste STTM members reported. So they have had plenty of time to correct this problem but didnt so am afraid I dont have a lot of sympathy for Acella. They let their patients down badly. Erfa also changed years ago and I came off that for the consequent variations too which I understand are still ongoing.....patients in Canada have no option but to use Erfa but continue to complain about it. For me that left Armour.......which didnt suit me since they changed their formulation backin 2011 and the change in filler -however since then with all the b12 jabs I now have these days I seem to be coping ok with it. Fingers crossed. Otherwise really dont know what I am going to do!!
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