Thyroid Drug Recall - U.S.

[vocalEK]

"Acella Pharmaceuticals, LLC is voluntarily recalling certain lots of the hypothyroid medication NP Thyroid. According to the company announcement, the thyroid medication recall follows tests showing certain lots are “superpotent.” The affected products may have up to 115.0% more liothyronine (T3) than what is on the label. "

druganddevicewatch.com/2020...

[vocalEK]

Headline reads "Drug Could Cause Hyperthyroidism". Article written by a law firm that doesn't understand that hyperthyroidism only occurs when one's own thyroid gland is producing too my hormone. The proper term for this situation would be "overmedication."

[jimh111]

The statement:

The affected products may have up to 115.0% more liothyronine (T3) than what is on the label.

is wrong. The correct statement is:

The product may have up to 115.0% of the labeled amount of Liothyronine (T3).

i.e. 15% more than what is on the label. This is minor as many drugs have a requirement to be in a potency range. e.g. 90% - 110%.

Although the correct term is 'thyrotoxicosis' I prefer the term hyperthyroidism as what matters is the effects and they are the same if the excess hormone comes from the thyroid or tablets. I also dislike giving the impression that thyroid hormone is a toxin. This is my preference, not asserting a fact.

[vocalEK in reply to jimh111]

Let's do a little math. According to Drugs.com NP Thyroid (usually) contains 9 mcg liothyronine per grain. 30 mg is 1/2 grain, 60 mg is 1 grain , and 90 mg is 1-1/2 grains.

drugs.com/pro/np-thyroid-30...

So

4.5 mcg * 1.15 = 6.76 mcg

9 mcg * 1.15 = 10.35 mcg

13.5 mcg * 1.15 = 15.525 mcg

That is nowhere NEAR an overdose. My doc started me out on T3 tablets containing 25 mcg. (Of course, I cut them up and started myself on a quarter of that, working my way up to the full tab.)

But if 25 mcg isn't an overdose, 115% of the Liothyronine in NP Thyroid doesn't seem likely to be at all harmful.

[helvella Administrator Thyroid UK in reply to vocalEK]

If you consider levothyroxine, it is allowed to contain liothyronine up to 1% of claimed potency. That is, a 100 microgram levothyroxine tablet could contain up to 1 microgram of T3. (I think this is the same for the USA and the UK, but could be slightly different.)

Quite likely that no tablets ever do contain that much, maybe nowhere near that. We cannot tell. And if they did, someone would probably be expected to investigated as to why.

That is close enough to the incremental amount in one grain.

I think the interesting question is how this could happen.

[jimh111 in reply to vocalEK]

Yes, it's 15% of the T3 content which is not a lot especially when it has T4 also. The drug should be recalled because it doesn't meet specification but the error is small. Not quite as bad as some compounding pharmacies who have mistaken mg for mcg!

[helvella Administrator Thyroid UK in reply to jimh111]

Which is why there are many statements to the effect of "never abbreviate microgram - always write it out in full".

I try to do so - though not when specifically quoting, where the copy and paste process is seductively easy or the accuracy of the quote is more important.

[waveylines in reply to vocalEK]

No not harmful but you may over shoot your sweet point and need to lower your dose a tadge.

[vocalEK]

fda.gov/safety/recalls-mark...

"Patients should talk to their healthcare professional before they stop taking their NP Thyroid medicine. "

You would think that if the amount were actually toxic, the FDA would have advised patients to stop taking it immediately.

[waveylines]

Thanks. Am on NP Thyroid and I have to say I havent noticed a difference at all......infact unusual for me I have had to put my dose up slightly in the hot weather! Usually the other way round!

Does it list batch numbers? Would be helpful if they did!

My uk pharmacist hasnt contacted me about it.

[waveylines]

Apologies they have listed the batch numbers.