0000000000583128
AUTHOR
Dirk Lang
Risk of bleeding related to selective and non-selective serotonergic antidepressants: a case/non-case approach using data from two pharmacovigilance databases.
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.Based on data (spontaneous reports of adverse drug reactions) from 2 pharmacovigilance databases (WHO-database/Vigibase™; BfArM/AkdÄ-database in Germany) we used a case/non-case approach and calculated reporting…
Drug-Induced Liver Injury Associated With Antidepressive Psychopharmacotherapy: An Explorative Assessment Based on Quantitative Signal Detection Using Different MedDRA Terms.
Drug-induced liver injury is a major problem of pharmacotherapy and is also frequent with antidepressive psychopharmacotherapy. However, there are only few studies using a consistent methodologic approach to study hepatotoxicity of a larger group of antidepress ants. We performed a quantitative signal detection analysis using data from the Uppsala Monitoring Centre from the WHO that records adverse drug reaction (ADR) data from worldwide sources; we retrieved substance- and country-specific (Australia, France, Germany, Italy, Spain, the United Kingdom, and the United States) ADR data and calculated reporting odds ratios as measures for disproportionality within a case/noncase approach. To a…
Drug safety related to agents used for opioid maintenance therapy
IntroductionThere is only little data regarding drug safety related to agents used for opioid maintenance therapy (OMT).Objectives/aimsTo study drug safety and the reporting behaviour of adverse drug reactions (ADR) related to OMT.MethodsA cross-sectional questionnaire-based telephone survey among physicians providing outpatient OMT in a federal state of Germany (n = 176; response rate = 55.7%) was conducted.ResultsMost of the respondents (n = 97/55.1%) reported that they observe ADR related to buprenorphine, [dihydro]codein and [levo]methdone rarely (n = 38/21.6%), very rarely (n = 39/22.2%) or never (n = 20/11.4%). Methadone was reported to be most frequently associated with the occurrenc…