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Parliamentary questions
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8 August 2018
Answer given by Mr Andriukaitis on behalf of the European Commission
Question reference: E-003511/2018

The change to a new formulation of Levothyrox was requested by the French authorities to reduce deterioration of the active substance over time during storage of the tablets. This change also provided the opportunity to avoid lactose, unsuitable for patients with lactose intolerance, in tablets’ composition.

The marketing authorisation holder for Levothyrox has initiated a procedure to make the same formulation changes to most of its levothyroxine medicines across the EU. In this context, the German regulatory authority, Das Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), which is leading the procedure, sought advice from the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) on any potential safety concerns with the new formulation. Based on the available information, the PRAC agreed that there is no difference in the pattern of adverse events reported before and after the switch to the new formulation.

In general, side effects associated with a switch to a new formulation of levothyroxine are expected in some patients because this medicine has a narrow therapeutic index, which means that the difference between the therapeutic dose and a dose which may trigger side effects is very small.

In January 2018, the PRAC recommended issuing specific advice to healthcare professionals on how to manage patients when switching from one formulation to another. This includes blood tests to ensure that the dose is adjusted to the individual patient situation. Particular attention should be paid to vulnerable groups, including patients with thyroid cancer and cardiovascular disease, pregnant women, children, and the elderly.

Last updated: 8 August 2018Legal notice