Cardiovascular Adverse Reactions During Antidepressant Treatment: A Drug Surveillance Report of German-Speaking Countries Between 1993 and 2010

Abstract

Background:Antidepressants (ADs) are known to have the potential to cause various cardiovascular adverse drug reactions (ADRs). The tricyclic antidepressants (TCAs) were first revealed to be a possible source of cardiovascular ADRs. In recent years, newer classes of ADs were also suggested to have a higher risk of cardiovascular adverse effects. In particular, the selective serotonin reuptake inhibitors (SSRIs) were suspected to have the potential to induce QTc interval prolongation, and therefore increase the risk of ventricular arrhythmia. This descriptive study is based on the continuous pharmacovigilance program of German-speaking countries (Austria, Germany, and Switzerland), the Arzneimittelsicherheit in der Psychiatrie (AMSP), which assesses severe ADRs occurring in clinical routine situations.Methods:Of 169 278 psychiatric inpatients treated with ADs between 1993 and 2010, 198 cases of cardiovascular ADRs (0.12%) were analyzed.Results:Our study showed that the incidence rates of cardiovascular ADRs were highest during treatment with monoamine oxidase inhibitors (0.27%), TCAs (0.15%), and serotonin noradrenaline reuptake inhibitors (0.14%); the risk of occurring during treatment with SSRIs (0.08%) was significantly lower. The noradrenergic and specific serotonergic AD mirtazapine (0.07%) had a significantly lower risk of cardiovascular ADRs than all other ADs. Severe hypotension was the most frequent ADR, followed by hypertension, arrhythmia, and in some rare cases heart failure.Conclusions:Despite certain limitations due to the AMSP study design, our observations on cardiovascular ADRs can contribute to a better knowledge of the cardiovascular risk profiles of antidepressants in the clinical routine setting. However, prospective studies are needed to verify our findings.

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“…In the intensive care unit (ICU), the prevalence of drug‐associated hypotension ranges from 23% to 81% . Hypotension causes insufficient cardiac perfusion and fatal consequences for patients in the ICU . Indeed, in a previous study, episodes of hypotension were found to exert deleterious effects, such as increased mortality rate and decreased functional outcomes, on patients with head injuries…”

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“…Increased heart rate and sustained hypertension. Antidepressants with noradrenergic action, such as SNRIs (class AIIb) and bupropion (class AIIc) present the risk of increasing both blood pressure and heart rate via their sympathomimetic effects [19,24,29,69]. For this reason, the risk of hypertension is communicated within the warnings and precautions of the full prescribing information of these medications.…”

“…However, it should be considered that some antidepressants with noradrenergic action antagonize the α 1 -adrenergic receptor and thus counteract the increase in blood pressure, causing a very low incidence of this ADR, as is the case of mirtazapine (class AIII) and mianserin (class AIVb) [69]. In some cases, they can even cause orthostatic hypotension as usually seen with class AIVc (traditionally called tricyclic).…”

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“…The introduction of fluoxetine highlighted the increased suicide risk during treatment initiation, which seems to be also relevant during withdrawal or dose reduction and which may be more common in adolescents or young adults. 34,35 Large case-control studies have demonstrated a higher likelihood of serious cardiovascular events in persons receiving tricyclic antidepressants (TCAs) or serotoninnorepinephrine reuptake inhibitors (SNRIs) 36 in part through corrected QT interval prolongation particularly with TCAs, a fact that may also contribute to an apparent increase in mortality. 37 SSRIs double the risk of clinically relevant gastrointestinal bleeding, especially when combined with aspirin or nonsteroidal antiinflammatory drugs.…”