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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: 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]

We report our experience with a 34-year-old patient with schizophrenia, paranoid subtype, who demonstrated an elevation of clozapine serum levels subsequent to pregabalin comedication used for the treatment of schizophrenic anxiety. This observation turned to be dose-dependent. Although the pharmacokinetic profile of pregabalin suggests an exclusive renal elimination, our report supports the presumption of a possible direct or indirect hepatic "effect" of pregabalin. [ABSTRACT FROM AUTHOR]

Introduction: Weight gain is a common side effect of antipsychotic and antidepressive drug therapy, difficult both to avoid and to treat. In several randomized controlled studies, add-on treatment with metformin has been demonstrated to reduce olanzapine-induced weight gain. In our department of psychiatry and psychotherapy, metformin has been used against antihistaminic-drug-induced weight gain since 2008. Objectives: Primary: To demonstrate the efficacy of metformin for prophylaxis of antihistaminic-drug-induced weight gain in a cohort of psychiatric in-patients under naturalistic conditions. Secondary: To identify side-effects of add-on metformin therapy in non-diabetic psychiatric in-patients. Methods: Retrospective case-control analysis of in-patient charts from 3400 psychiatric therapies between 2008 and 2010 at Ulm University Department of Psychiatry and Psychotherapy III. Cases were identified on the basis of metformin prescription without a diagnosis of diabetes. Controls were matched for gender, age, BMI, diagnosis, and drug treatment. Evaluation will be performed with descriptive statistics, covariance analyses and mixed models. Results: No serious side effects could be attributed to metformin therapy on the basis of the charts reviewed. Further results will be presented at the meeting. Conclusions: Metformin appears to be safe with regard to side effects in psychiatric in-patients taking anti-histaminic drugs. [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.

Introduction/objectives/aims: Gynecomastia and hypogonadism can occur during treatment with a range of antidopaminergic drugs and is most likely to a medication induced increase in serum prolactin levels. However there is little evidence for an association between antidepressants and hypogonadism. Methods: We report the case of a 23 year old male with a 3 year history of bulimia nervosa and recurring depression who had been treated with duloxetine for a period of 6 months during which he developed pronounced bilateral gynocomastia. Since serum prolactine and serum testosterone levels were normal and duloxetin was initially not considered causative, the drug was continued and bilateral gynecomastia was performed. 4 months later the patient again experienced tension and swelling in the breast. Results: The endocrinologic exams revealed reduced serum testosterone levels and reduced testicular volume. Body weight was 63kg, height 176cm and a neurological exam, including olfactory testing and MR brain imaging was normal. Hypogonadotropic hypogonadism was diagnosed. Discussion: Increased prolactin levels under antipsychotic medications are not uncommon. Some rare instances of gynecomastia have been reported under fluoxetine and venlafaxine, always associated with increased serum prolactin levels. In the present case the close tempral relationship between initiation of duloxetine and the development of gynecomastia and the recurrence under continued medication and resolution after termination of the medication suggests a possible causal relationship. The normal prolactin levels argue against anvolvement of prolactin in the pathogenesis. We suspect a prolactine independent mechanism. [ABSTRACT FROM AUTHOR]