A man in full antidepressant treatment jumps into the void in Alicante. His wife maintains that the medication is partly to blame: "Following taking the medication lost the brightness in the look. Sometimes you looked at him and it was like he was not inside. " While reading his story in Soria, Alejandro has the impression that he is reading that of his father-in-law, a recently retired farmer, too. no history of depression and to which also the substitute of his family doctor prescribed an antidepressant of the same type. In a week, the father-in-law also lost weight suddenly, "to the point that the rings fell off". And committed suicide, as did another woman whose daughter also blames the medication, but for the moment does not want it to transcend any more information.
The widow of Alicante and the son-in-law of Soria are convinced that one of the factors that precipitated the death of their relatives was the pills of the group of Selective Serotonin Reuptake Inhibitors (SSRIs). To the point that they will claim through various judicial channels. However, none – neither the woman's daughter, who especially laments the lack of information about the risks – has reported suicide as a possible adverse effect on the alert system of the Spanish Medicines Agency. The causes vary: the son-in-law did not know that he existed, the widow did not remember him and the daughter assumed that doctors would do it. The consequence is the same: the most serious potential effects, against which even the prospectuses are warned, are not recorded. Therefore, are they monitored?
Before continuing, it is important to clarify one thing. Millions of people consume antidepressants from the SSRI group around the world, also in Spain. The history of some of those SSRIs in particular, such as paroxetine, is written in the thread of trials and studies with contradictory results about their efficacy, and stitched up by bad practices by pharmaceutical companies. But in the absence of a clear consensus on the risks or benefits of taking them, yes there is agreement about the danger of abruptly stopping them: treatments should never be interrupted without medical advice.
Beyond denouncing potential side effects of these antidepressants, the question is whether the mechanism in charge of registering and analyzing them from voluntary notification is effective. 15 years ago, suspicions of the possible relationship between SSRIs and suicidal impulses led the European Medicines Agency to disavow the use of almost all of them, except fluoxetine, in children and adolescents. The same position adopted the Spanish agency. However, that same correlation "could not be evidenced for adults", according to the professor of pharmacology at the University of Barcelona, Elena Escubedo.
Although you can also communicate directly with the contact points of the Autonomous Communities, the so-called Yellow Card system It is the main mechanism to detect adverse effects of medicines in Spain. Anyone can use it: just know that it exists, look for the website of the Spanish Agency of Medicines and click on the Notifications tab. But seen the cases reported: Is it a sufficiently effective system? "No, it's not enoughNot much less. Because part of the voluntary notification and is notified very little about the things that really happen, "says Juan Erviti, head of the Section of Innovation and Organization of the Navarre Health Service.
Professor Escubedo also admits that "not everyone knows" that notification system. But "underregistration" or "under-reporting" is not attributable only to patients and family members. Nor do doctors usually communicate. "To the psychiatrist or to any doctor who sees a patient with depression, to be told that he has committed suicide, does not miss him. The possibility of suicide enters his picture of what depression is, "he explains. Joan Ramon Laporte, professor emeritus and former professor at the Autonomous University of Barcelona and former Director of the Catalan Institute of Pharmacology Foundation.
"That they tell a doctor that a patient with depression has committed suicide does not surprise him, something like that enters his picture of what depression is"
Instead, they are likely to communicate "unexpected" adverse reactions. "If a patient takes paroxetine and has a rash, (the doctor) does communicate it: the very nature of the disease caused by the drug determines whether the doctor notifies or not," he adds. Thus, the Yellow Card system is more prone to register exceptions, while more serious cases can sometimes be masked as "normal" in a depression.
The data points in that direction. Since 2005, notifications of suspicions about antidepressants add nine cases of "consummated suicide" reported for all SSRIs, none for the specific case of paroxetine, according to data from the Spanish Agency for Medicines and Health Products (AEMPS). If the cases of "suicidal ideation" (26) and "suicide attempt" (32) are included, the SSRIs add up to 74 notifications related to suicide in 14 years. The other reported suspicions regarding these same antidepressants add up to 3,902.
"The notification of a case of suspected adverse reaction at all can establish or attribute to the drug the adverse reaction reported," clarify from the AEMPS. The suspicion must then be evaluated taking into account various criteria, including possible alternative causes or factors present in the patient that may have influenced. "This is especially important in the case of the risk of suicide by antidepressants since depression itself is already a risk of suicide," they add those same sources.
It is necessary to go a step further to address the problem, with a "more active and more proactive" monitoring of patient data and histories
However, both Laporte and Erviti defend the need to go at least one step further and address the problem from the study of available and accessible data and medical records. "With epidemiological methods, not only have undesirable effects been discovered, but the sequence has been determined, which is even more important, "explains Joan Ramon Laporte. "It is true that we need a more active and more proactive follow-up," according to Erviti.
Juan Erviti agrees with Laporte when pointing out the way forward: "Do studies with information from electronic medical records and databases that have a sufficient amount of information and that does not depend on voluntary notification." The voluntary notification system adds, "allows to identify signals ", "But it does not quantify the magnitude of the problem, nor can it be attributed causality on many occasions," he concludes.
But in Spain perhaps even a previous step is necessary. Suicide is the leading cause of violent death in our country, over and above traffic accidents, for years. However, an inertia of decades extended a thick silence, from the Catholic Church to the press, on the matter. Until September 2018 the first one was not presented National Plan for the Prevention of Suicide, that the previous year had caused the death of 3,679 people. In many families, death by suicide is still attributed to an accident. "When they make a campaign to break the taboo of suicide on television as they do with traffic accidents, then I can face it," says one of those relatives.