Question 821 — pharmacy and medications

Summary

Following a pharmacovigilance investigation, the National Medicines and Health Products Safety Agency (ANSM) requested a modification of the Levothyrox® formula due to instability in the active ingredient content and the presence of an excipient with a notorious effect, such as lactose. The new, more stable formula was placed on the market in March 2017. Since that date, the regional pharmacovigilance centers (CRPV) of Rennes and Lille have identified, out of 3 million patients, 9,000 reported cases of adverse effects, including no serious effects. Without minimizing or denying the symptoms experienced by certain patients, they are invited to contact their treating physician or their endocrinologist to find with them the most precise dosage resulting from the new Levothyrox® formula. It must be borne in mind that the only danger for these patients is that they stop taking their treatment. The health risk for patients of the new formula is unchanged. The ANSM verified the conformity of the new formula and found no impurities in Levothyrox. An additional pharmacovigilance investigation is underway and will provide its results in October. The ANSM will be perfectly transparent on all these monitoring measures; it will communicate and invite patient associations to present the results to them. In addition, the Minister of Solidarity and Health recognizes that this specialty benefits, in France, from a quasi-monopoly, which should be opened up to other medicines. In the very short term, L-thyroxine drops may constitute an alternative for patients with persistent symptoms, provided that the available stocks remain sufficient for those for whom the tablets are not available. usable. The importation of alternative drugs to Levothyrox® present in Europe has also been decided. There are nevertheless inexhaustible legislative and regulatory deadlines which guarantee the safety of medicines. The arrival time for these drugs in France will be known soon. The minister decided to launch a mission aimed at improving communication on medicines and information for patients and health professionals. 100,000 letters were sent by the ANSM to health professionals (doctors, pharmacists, etc.) to inform them of the change in formula. The mission must take into account new means of communication and be vigilant about the quality of information. Finally, two meetings were organized, on September 6 and 8, 2017, by the Minister of Solidarity and Health, with the association “Vivre sans thyroid" and the association "France Asso Santé" then with the French association of thyroid patients to inform them of the measures taken to support patients affected by adverse effects, to allow the arrival of alternative medications on the French market, and finally to better inform patients and healthcare professionals about medications in the future.

Machine translation from French. The official text remains authoritative.

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