Following extensive changes to the formulation and manufacture of levothyroxine tablets by Teva, the Commission on Human Medicines (CHM) is now reassured that Teva has demonstrated an acceptable level of efficacy and safety to allow their levothyroxine tablets to re-enter the market. Additional tablet strengths have also been introduced, to improve precision of dosing.
In February 2012 the Commission on Human Medicines (CHM) advised the suspension of the marketing authorisation for levothyroxine 100 microgram tablets manufactured by Teva, following reports of reduced efficacy when patients switched to Teva levothyroxine from other levothyroxine products. There were also manufacturing issues.
Suspension now lifted
Teva has followed the CHM’s advice in full, including recommendations following a wider CHM review of levothyroxine tablets, published in January 2013. Teva has undertaken an extensive reformulation of the 50 and 100 microgram tablets, along with manufacturing process improvements that provide assurance of product consistency. In February 2016, CHM reviewed information about the reformulated products and advised that they have an acceptable level of efficacy and safety and could now be re-introduced to the market.
New tablet strengths introduced
Teva has also introduced three additional tablet strengths of 12.5, 25 and 75 micrograms, two of which are new to the UK market. The new tablet strengths will assist dose adjustment for individual patients, which is an important component of optimal thyroid hormone replacement therapy, whilst avoiding the need to split individual tablets.
A total of five tablet strengths will be available from week commencing 17 October, 2016: 12.5, 25, 50, 75 and 100 micrograms.
These products do not contain lactose
They are therefore suitable for patients who have lactose intolerance, as well as the less common but more serious galactose intolerance.
Advice for healthcare professionals
Clinical studies conducted in volunteers have confirmed that the reformulated Teva levothyroxine tablets produce levels of thyroid hormone in the bloodstream that are equivalent to those produced by the brand leader (UK reference) product.
The formulation and manufacturing process improvements provide assurance that equivalent systemic availability will apply to future batches of product, and that this will be maintained over the duration of the shelf-life. Assurance of consistency in performance is therefore provided.
Lactose, converted in the body to galactose, has been removed from the formulation. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption can now take this medicine.
Patients should continue to be monitored at intervals for clinical signs and symptoms of adequate thyroid hormone replacement, together with measurement of TSH levels. Patients can display differences in thyroid hormone response, and can require adjustments in dose, for reasons that are unrelated to pharmaceutical properties of the product.
For more information on the assessment of the re-formulated products and the additional strengths, please refer to the Public Assessment Reports (PARs), which can be accessed here:
Published: 17 October 2016