Until the mid 20th century the treatment of hypothyroidism was a natural product taken from a pig's thyroid. this contained all the necessary hormones needed in full replacement therapy including T4, T3, T1, T2 and Calcatonin. However with the invention of a synthetic version, Thyroxine, (only containing T4) this product fell out of favour like so many others due to drug company funding etc.

However a large minority of people have trouble converting T4 to T3 and find more relief when taking the natural product, or adding the T3 medication Cytomel to their daily dose. As a consequence more and more people are now switching back to the natural alternative.

Contrary to popular medical opinion this product is perfectly safe, will not give you swine fever, has been rigorously tested for the perfect T4/T3 balance and is in fact only unlicensed in the National Formulary because when such methods came into being it was considered safe by virtue of it being a long standing medication and as such didn't need one. Levothyroxine was also initially grandfathered in but due to many problems it had in fact to apply for a licence to ensure it's safety

The following is a letter from the MHRA to say that Armour can be prescribed in the Uk for the treatment of Hypothyroidism. If you want to try armour and you doctor says it can't be prescribed on the NHS please take a copy of this to show them otherwise. Many people are now taking armour or T3/T4 combination on the NHS and experiencing relief from their symptoms. The prescription shoudl eb hand written giving the dosage needed and say 'For the treatment of hypothyroidism' The pharmacist then needs to order it from the importer IDIS some chemist such as Boots have an account with IDIS so can fax straight through. It normally takes about 4 days to arrive 

Thank you for your earlier telephone call on behalf of Thyroid UK concerning Armour Thyroid, which is imported as an unlicensed medicine under the relevant regulations.

I am responsible for the professional aspects of the importation of unlicensed medicine and would like to clarify the situation with respect to the above products, as requested.

As you know, synthetic levothyroxine T4 and Liothyronine T3 are available in the UK as licensed medicinal products. "Natural" desiccated thyroid hormone, which contains both T4 and T3, is extracted from the thyroid glands of pigs, and is marketed in the USA under a number of brands. Some of these brands are marketed under US law as food supplements and as such are not authorised by the Food and Drugs Administration (FDA). These products can vary considerably in the content of thyroid hormones, because they are not standardised, and as a result could potentially be dangerous. However, other brands are authorised by the FDA as medicines, and are standardised to the specification of the United States Pharmacopoeia (USP).

The specification of the USP for the content of T4 (85 to 115% of labelled strength) and T3 (90 to 110%) in natural thyroid tablets are similar to the specifications for the content in the individual synthetic hormones (90 to 110% T4, 90 to 110% T3). Thyroid tablets USP contain approximately 38 micrograms of T4 and 9 micrograms of T3 per 65 milligrams of desiccated thyroid, and are available in a wide variety of strengths.

UK and European law recognises that there may be circumstances when licensed products may not be suitable for some patients. The regulations on medicines allow doctors to prescribe an unlicensed medicine for a patient to meet such a special clinical need, on their own direct personal responsibility. Where these unlicensed medicines are not available in the UK they can be imported by appropriately licensed medicines wholesalers, in response to unsolicited requests for supply to a doctor or pharmacy, to meet these needs. The importer is required to notify the MHRA in advance of every occasion that they wish to import such a product. The product may not be promoted in any way.

The MHRA can object to importation of an unlicensed medicine if there are concerns about the safety or quality of the product. The MHRA cannot object to importation of an unlicensed medicine solely on the grounds of efficacy. In the case of these thyroid preparations, the MHRA has not objected to their importation provided that they are authorised prescription only medicines, standardised to the USP, and that they are for the treatment of patients with thyroid diseases, for whom the UK licensed synthetic thyroid hormones are not suitable.

We have not told importers that they must provide evidence from prescribers, as this is a matter of clinical judgement. Consequently, these products can be made available to those people who need them, subject to them being prescribed by a doctor.

I hope that this answers your concerns. If you have any further questions, please do not hesitate to contact me.

Graham Matthews
Pharmaceutical Assessor
Defective Medicines Report Centre
MHRA
Market Towers
1 Nine Elms Lane
London SW8 5NQ
Tel: 020 7084 2715
Fax: 020 7084 2676

published courtesy of www.thyroiduk.org 

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