Olanzapine is a tricyclic neuroleptic agent that due to structural similarities was expected to be a safe alternative to clozapine, which has a 0.5-2% risk of agranulocytosis. So far, only rare cases of leukocytopenia and thrombocytopenia have become known. In the association, "Drug Safety in Psychiatry", which is made up of 25 German psychiatric hospitals, two cases of olanzapine-induced neutropenia occurred in patients with chronic schizophrenia. The adverse drug reaction was noticed 17 days after the first intake of olanzapine in case 1 and more than 5 months after the first intake in case 2. In the second case, a reexposure to olanzapine caused the neutrophil cells to decrease again. There were no clinical signs of an infection, and the blood cell counts increased immediately to normal ranges after discontinuation of olanzapine. No special treatment was necessary.

Introduction: Migraine is a neurological disease with a considerable economic and societal burden that negatively impacts quality of life and productivity. Triptans are potent serotonin receptor agonists widely used to treat migraine attacks. Little is known about German patients with migraine diagnosed with triptan contraindications or those who discontinue triptans. Methods: This retrospective observational study identifies adults with migraine from a German sickness fund database (2010)(2011)(2012)(2013)(2014)(2015)(2016)(2017)(2018). Migraine prevalence was calculated for the database population and extrapolated to the German Statutory Health Insurance (SHI) population. Medication use, proportion and demographics of patients with triptan contraindications, prevalence of triptan discontinuation and use of triptans by patients with contraindications were analysed.Results: In total 120,170 patients with migraine were identified in the database population, of whom 77.7% were female; migraine prevalence was 2.0% (male) and 7.3% (female), leading to an extrapolated 2,923,979 patients with migraine in the entire German SHI population (2019); of these, 14.5% had C 1 triptan contraindication. The most frequent contraindication was a history of stroke/transient ischaemic attack. However, an extrapolated 25.9% of patients who had a triptan contraindication received a triptan prescription following diagnosis. We calculated that 975,698 patients in the entire German SHI population had ever received a triptan, of whom 596,364 did not receive a triptan prescription in the follow-up year. Of these 596,364 individuals, 96.6% continued to receive a migraine diagnosis after their last triptan prescription. These 'triptan discontinuers' were predominantly female (82.6%). Most patients utilized only one specific triptan, with a large majority of ongoing triptan users who had used this specific triptan receiving [ 4 prescriptions. Conclusion: We confirm the existence of German patients with migraine and unmet therapeutic needs. These are patients diagnosed with triptan contraindications or patients who have discontinued triptan use despite continued migraine attacks. More research is needed to ascertain reasons for triptan discontinuation and the risk of triptan use by patients with contraindications.

AIMSTo evaluate the safety and tolerability of duloxetine during routine clinical care in women with stress urinary incontinence (SUI) in Germany, and in particular, to identify previously unrecognized safety issues as uncommon adverse reactions, and the influence of confounding factors present in clinical practice on the safety profile of duloxetine. METHODSOffice-based urologists, gynaecologists and primary care physicians were asked to document women newly started on treatment for moderate to severe symptoms of SUI. Six thousand eight hundred and fifty-four patients from urologist/gynaecologist practices and 5879 primary care patients were assessed. In a two-armed, observational study with parallel 12 week (urologists and gynaecologists) or 24 week (primary care physicians) design, patients were treated with duloxetine or other conservative treatment. The main outcome measure was the occurrence of adverse events (AEs). RESULTSBaseline characteristics differed slightly between patient groups and studies. Duloxetine doses in most patients were lower than recommended. Overall, AE frequency with duloxetine was lower than in controlled studies (15.9% (95% CI 14.9, 16.9) and 9.1% (95% CI 8.2, 10.0) in the 12 and 24 week treatment groups, respectively), but exhibited a similar qualitative spectrum. In the logistic regression models, the following factors were associated with greater AE risk: investigator specialization (gynaecologist vs. urologist and primary care physician), initial duloxetine dose (80 vs. 20 mg day ) and use of any concomitant medication. Within the 24 week study, a positive screen for depressive disorder was surprisingly common, but no case of attempted suicide was reported in either study. CONCLUSIONSOur results from German clinical practice show that women with SUI were often treated with duloxetine doses lower than recommended. This was associated with a low incidence of AEs. Suicide attempts were not reported. WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT• Duloxetine was safe in double-blind, randomized controlled trials but additional safety concerns have emerged for amine uptake inhibitors as a class, particularly with regard to suicidality. Clinically used duloxetine doses are often below the recommended doses. WHAT THIS STUDY ADDS• Real life data confirm the tolerability and safety of duloxetine and in a population covering 3233 patient years no evidence for suicidality was seen. The prescribed duloxetine doses, which often are lower than the recommended ones, are associated with qualitatively similar but fewer adverse events than in controlled studies. Our parallel group design may be of value for observational studies in other therapeutic areas as well.

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