Tianeptine, antidepressant with positive benefit/risk

Dear Editor,

In reply to the letter published in the Rev Psiquiatr Salud Ment (Barc.). 2016;9:176–177 by Calabozo et al.,¹ under the title “Tianeptine: why has it not been classified as a narcotic in Spain?”, here in Juste SAQF we would like to express certain considerations. Firstly, Juste SAQF is a pharmaceutical company which commenced the commercialisation of medicines in the Spanish market in the year 1922, and since its origins it has always been characterised by strict compliance with the parameters that guarantee patient safety and well-being. Health is the chief objective of Juste, and therefore, according to the pharmacovigilance regulations in force, it monitors medicines and continuously and permanently evaluates their safety profile.

Tianeptina (Zinosal^®) is a generic medicine which was authorised in Spain on 13/08/2014, and it is currently commercialised by our company. Tianeptine has been commercialised in France since 1988, and it is authorised in 15 European countries and in 66 countries around the world. The safety profile of Tianeptine is still monitored in the countries where it is authorised, and additionally, it is included in the EURD-list of the EMA for single evaluation of the Periodical Safety Report (PSUSA/00002943/201806; updated DLP: 04/03/2016).

This pharmacovigilance is fundamental given that, as with all medicines, adverse effects may arise which permit the evaluation of each drug in terms of its benefits and risks for each specific disease. In this respect, it is necessary to underline that the last revision undertaken by the French authorities on 5 December 2012, on Tianeptine, concluded that its benefit/risk ratio is still positive.² Based on this evaluation, in the section of adverse reactions of the technical data sheet of Zinosal^®, it is said that it may be involved in “substance abuse and dependency”, although it states that this basically involves a specific type of patient: “above all in patients under 50 years old with a history of drug or alcohol abuse”, while this adverse reaction is classified under the heading of “Rare” (>1/10,000 to >1/1000).

Two years later, in 2014, the French National Medicine and Health Products Safety Agency re-evaluated the information from 2012 to 2013, concluding that the number cases of abuse involving Tianeptine had fallen, given that only 7 cases³ had been described (ANSM, 2014).

Moreover, it is important to emphasise that Tianeptine has a different pharmacodynamic profile from those of current antidepressants,^4,5 and that it has been proven in comparative studies to be more effective than a placebo and not inferior to tricylcic antidepressants or SSRI, with a more favourable tolerability profile.^5–11

As the French public health authority (HAS) points out, Tianeptine² has a positive benefit/risk ratio. Given that not all patients respond to existing antidepressant treatments, and given the clearly different action of Tianeptine on possible mechanisms that lead to an antidepressant effect, approval of its use in Spain represents a broadening of the spectrum of antidepressant treatment that has duly been authorised by the AEMPS for commercialisation under the commercial name of Zinosal^®. Juste guarantees the pharmacovigilance of this drug in the same way that it does for all those within its catalogue.