Search

Introduction: Drug safety surveillance strongly depends on the spontaneous reporting of adverse drug reactions (ADRs). A major limiting factor of spontaneous reporting systems is underreporting (UR) which describes incorrectly low reporting rates of ADRs. Factors contributing to UR are numerous and feature country-dependent differences. Understanding causes of and factors associated with UR is necessary to facilitate targeted interventions to improve ADR reporting and pharmacovigilance. Methods: A cross-sectional questionnaire-based telephone survey was performed among physicians in outpatient care in a federal state of Germany. Results: From n = 316 eligible physicians n = 176 completed the questionnaire (response rate = 55.7%). Most of the physicians (n = 137/77.8%) stated that they report ADRs which they have observed to the competent authority rarely (n = 59/33.5%), very rarely (n = 59/33.5%) or never (n = 19/10.8%); the majority (n = 123/69.9%) had not reported any ADRs in 2014. Frequent subjective reasons for non-reporting of ADR were (specified response options): lack of time (n = 52/29.5%), the subjective evaluation that the required process of reporting is complicated (n = 47/26.7%) or requires too much time (n = 25/14.2%) or the assessment that reporting of an ADR is needless (n = 22/12.5%); within open answers the participants frequently stated that they do not report ADRs that are already known (n = 72/40.9%) and they only report severe ADRs (n = 46/26.1%). Discussion: Our results suggest a need to inform physicians about pharmacovigilance and to modify the required procedure of ADR reporting or to offer other reporting options. [ABSTRACT FROM AUTHOR]

Introduction: There is increasing evidence for an association between treatment with selective serotonin reuptake inhibitors (SSRI) and an increased risk of bleeding events. The most important underlying mechanism appears to be inhibition of serotonin uptake in platelets, an effect that is also present in antidepressants with non-selective serotonin-reuptake inhibition (NSRI). Accordingly, also NSRI may be associated with an increased risk of bleeding. However, there is little data in this regard. Methods: Based on data (spontaneous reports of adverse drug reactions) from 2 pharmacovigilance databases (WHO-database/VigibaseTM; BfArM/AkdÃ-database in Germany) we used a case/non-case approach and calculated reporting odds ratios (ROR) as measures for disproportionality regarding the association of treatment with an agent of the group SSRI/NSRI and haemorrhages. Results: Whereas both positive control agents (ASS and diclofenac) were statistically associated with haemorrhages in both databases (ASS: BfArM/AkdÃ, ROR 13.71 [95 % CI 12.82 - 14.66]/ WHO, ROR 12.96 [95 % CI 12.75 - 13.16]; diclofenac: BfArM/AkdÃ, ROR 2.80 [95 % CI 2.59 - 3.03]/WHO, ROR 2.11 [95 % CI 2.05 - 2.16]), none of the agents of the group SSRI (ROR < 1) was associated with haemorrhages. In group NSRI, only St. John's wort/hypericum was associated with haemorrhages (WHO-database, ROR 1.31 [95 % CI 1.06 - 1.63]). Discussion: Signal detectioning in 2 pharmacovigilance databases suggests that serotonin reuptake inhibition is not associated with an increased risk of bleeding. However, underreporting may have accounted for the evaluated absent associations, particularly concerning SSRI. Regarding the detected increased risk of bleeding associated with hypericum, pharmacokinetic drug-drug interactions may be relevant independent of serotonin reuptake inhibition. [ABSTRACT FROM AUTHOR]

Introduction: Considering the antidepressant agomelatine (AGM) there is a discrepancy between the widespread knowledge of the potential of AGM to cause hepatotoxic adverse drug reactions (ADR) and the availability of corresponding published data. This impedes an adequate assessment of the hepatotoxicity profile of AGM. Methods: We conducted a query of the database of a German Medical Regulatory Body (BfArM) and analyzed spontaneous reports of hepatotoxic ADR. Results: We identified n=58 cases of AGMrelated hepatotoxic ADR. Most frequent ADR was asymptomatic increase of liver enzymes (79%); n=6 patients (10%) with AGM-related toxic hepatitis were reported. Characteristics of patients: female sex (69%), age > 50 years (mean 54 years), polypharmacy (57%), and presence of cardiovascular risk factors (58.5%). Most of the hepatotoxic ADR (90%) were reported to have improved/ recovered after discontinuation of AGM. Discussion: Our evaluation suggests that AGM features a potential to cause severe forms of hepatotoxicity and emphasizes that a pre-existing liver disease is a contraindication for treatment with AGM. Secondly, increased age, female sex and polypharmacy may be risk factors for the development of AGM-related hepatotoxic ADR [ABSTRACT FROM AUTHOR]

The article presents a case study of a 23-year-old male with bulimia nervosa and major depressive disorder who developed hypogonadism and gynecomastia under duloxetine treatment. The patient complained of swelling and tenderness in the breast after four months of duloxetine medication and bilateral mastectomy. The swellings and tenderness of the breast have subsided after discontinuation of the duloxetine medication.