Immune cell profiles associated with human exposure to perfluorinated compounds (PFAS) suggest changes in natural killer, T helper, and T cytotoxic cell subpopulations.

Per- and polyfluoroalkyl substances (PFAS) constitutes a group of highly persistent man-made substances. Recent evidence indicates that PFAS negatively impact the immune system. However, it remains unclear how different PFAS are associated with alterations in circulating leukocyte subpopulations.

Drug-induced kidney injury: A large case series from the Berlin Case-Control Surveillance Study .

Objectives: Drug-induced kidney injury (DIKI) may affect patients regardless of their baseline kidney function. Therefore, this study evaluated DIKI in patients with or without previous chronic kidney disease (CKD).

Materials And Methods: Potential DIKI cases were ascertained using the network of the Berlin Case-Control Surveillance Study in all 51 Berlin hospitals from April 2010 until December 2011.

Immobilization and high platelet count are associated with thromboembolic complications in heparin-induced thrombocytopenia.

Purpose: Immune-mediated heparin-induced thrombocytopenia (HIT type II, HIT) is a potentially serious adverse drug reaction characterized by an increased risk of venous and arterial thrombosis. This study aimed to identify risk factors associated with the development of these complications.

Methods: Our study cohort included patients with HIT assembled in our pharmacovigilance center by reports from 51 collaborating hospitals in Berlin, Germany.

Tocilizumab-induced pancreatitis: case report and review of data from the FDA Adverse Event Reporting System.

What Is Known And Objective: Tocilizumab (TCZ) is a humanized monoclonal antibody acting against the IL-6 receptor. It is a drug used in the treatment of rheumatoid arthritis and can be either given intravenously every 4 weeks or subcutaneously once a week. Known adverse events (AE) associated with TCZ include: infections of the upper respiratory tract, arterial hypertension, hypercholesterolaemia and hypertriglyceridaemia.

Herb-Induced Liver Injury in the Berlin Case-Control Surveillance Study.

Herb-induced liver injury (HILI) has recently attracted attention due to increasing reports of hepatotoxicity associated with use of phytotherapeutics. Here, we present data on HILI from the Berlin Case-Control Surveillance Study. The study was initiated in 2000 to investigate the serious toxicity of drugs including herbal medicines.

Metamizole (dipyrone)-associated agranulocytosis. An analysis of German spontaneous reports 1990-2012.

Purpose: In 1986, the risk of agranulocytosis prompted German authorities to restrict the indications for metamizole use. After an initial decline, prescriptions increased from <20 million defined daily doses in 1990 to >140 million in 2012. Concurrently, spontaneous reports of agranulocytosis increased from about 10 in 1990 to >50 in 2012.

Torsade de pointes tachycardia in a patient on dronedarone therapy.

Dronedarone is a promising, relatively new antiarrhythmic agent characterized by structural similarities to amiodarone but without amiodarone's severe organ toxicity. The proarrhythmic potential of dronedarone, however, is of increasing concern. We describe a 76-year-old woman who had been receiving dronedarone 400 mg twice/day to prevent recurrent atrial tachycardia with rapid ventricular response.

Drug-induced liver injury: results from the hospital-based Berlin Case-Control Surveillance Study.

Aim: Drug-induced liver injury (DILI) is often responsible for acute liver failure, drug withdrawal, boxed warnings or drug non-approval. Therefore, we conducted a case-control study to determine the hepatotoxic risk of a wide range of drugs.

Methods: The Berlin Case-Control Surveillance Study FAKOS included all 51 Berlin hospitals in a hospital network.

Metamizole-induced agranulocytosis revisited: results from the prospective Berlin Case-Control Surveillance Study.

Purpose: Treatment with metamizole (dipyrone) has steadily increased in Germany over the last decade. The consequences of this increase for metamizole-induced agranulocytosis (MIA) are unclear. The present study addressed this topic using data from the Berlin Case-Control Surveillance Study.

Flupirtine-induced liver injury--seven cases from the Berlin Case-control Surveillance Study and review of the German spontaneous adverse drug reaction reporting database.

Purpose: The hepatotoxic potential of the analgesic flupirtine has attracted increased attention over the past years. Recently, risk minimisation measures such as maximum treatment duration of 2 weeks have been requested by the European Medicines Agency (EMA). This study was conducted to further elucidate the clinical pattern of flupirtine-induced liver injury (FILI).

Drug-induced agranulocytosis in the Berlin case-control surveillance study.

Purpose: Drug-induced agranulocytosis (DIAG) is a rare but serious adverse drug reaction. The Berlin Case-Control Surveillance Study (FAKOS) aimed to identify pharmaceuticals with an increased risk for this condition.

Methods: Adult patients with acute non-chemotherapy-induced agranulocytosis, developed in hospital or in the outpatient setting, were ascertained by active surveillance in all 51 Berlin hospitals between the years 2000 and 2010.

Drug-induced acute pancreatitis: results from the hospital-based Berlin case-control surveillance study of 102 cases.

Background: Drug toxicity is a well-known cause of acute pancreatitis (AP). Although many drugs have been associated with AP, the magnitude of the risk of most of them remains largely unknown.

Aim: To determine the pancreatotoxic risk of a wide range of drugs.

Epidemiology of symptomatic drug-induced long QT syndrome and Torsade de Pointes in Germany.

Aims: Drug-induced long QT syndrome (diLQTS) leading to Torsade de Pointes (TdP) is a potentially lethal condition, which has led to several post-marketing drug withdrawals in the past decade. The true incidence of diLQTS/TdP is largely unknown. One explanation is under-reporting of this potentially life-threatening adverse event by physicians and other medical staff to pharmacovigilance agencies.

Severe sustained cholestatic hepatitis following temozolomide in a patient with glioblastoma multiforme: case study and review of data from the FDA adverse event reporting system.

Glioblastoma multiforme (GBM) is the most frequent malignant brain tumor in adults. Its established first-line adjuvant treatment is radiotherapy in combination with temozolomide (TZM). Hematotoxicity is listed as a frequent adverse drug reaction in the US prescribing information and hepatotoxicity has been reported infrequently in the postmarketing period.

Drug-induced immune thrombocytopaenia: results from the Berlin Case-Control Surveillance Study.

Purpose: Drug-induced immune thrombocytopaenia is a rare, serious condition that can be triggered by numerous medications. To characterize the spectrum of drugs associated with immune thrombocytopaenia (ITP) in the Berlin Case-Control Surveillance Study (FAKOS).

Methods: Adult hospitalized patients with new onset idiopathic, secondary or drug-induced acute ITP and hospital control patients were ascertained by active surveillance in 50 Berlin hospitals (>180 clinical departments) between 2000 and 2009.

Drug induced immune haemolytic anaemia in the Berlin Case-Control Surveillance Study.

Drug-induced immune haemolytic anaemia is a rare but serious condition. This study investigated the possibility of drug aetiology of immune haemolytic anaemia (IHA) in 134 patients with new onset of IHA who were identified in the Berlin Case-Control Surveillance Study between 2000 and 2009. Single drugs related to IHA in three or more patients and assessed more than once as a certain or probable cause of IHA in a standardized causality assessment included diclofenac, fludarabine, oxaliplatin, ceftriaxone and piperacillin.

Citalopram-induced bleeding due to severe thrombocytopenia.

Background: In case reports and observational studies, serotonin reuptake-inhibitors (SSRIs) have been linked to an increased risk of bleeding, possibly due to platelet dysfunction as a consequence of serotonin-uptake blockade into platelets.

Objective: The authors propose that bleeding as a result of SSRI use may also be caused by other mechanisms.

Method: Here, the authors report on a 32-year-old woman with hemorrhages resulting from severe drug-induced immune thrombocytopenia after 4 weeks of citalopram therapy.

Proportion of drug-related serious rare blood dyscrasias: estimates from the Berlin Case-Control Surveillance Study.

Drugs are an important cause of serious rare blood dyscrasias. To estimate the proportion of drug-related cases, we used data from the ongoing Berlin Case-Control Surveillance Study. The analysis included a total of 171 cases.

Unused drugs returned to the pharmacy--new data.

Introduction: Although the increasing costs in the health system in Germany is a frequently discussed topic, the amount of the so-called unused drugs which patients and customers bring back to pharmacies does not seem to diminish. In 1988, the authors conducted a study to document this problem. Ten years later, in 1998, a second study with the same design was done.

[Risk factors for urothelial carcinoma: drinking measures, smoking and other life style-related risk factors--results of the Berlin Urothelial Study (BUS)].

With the exception of smoking and several occupational exposures there is little knowledge about risk factors for urothelial cancer. A case control study in the area of former West Berlin was performed from 1990-1995 to investigate the role of several lifestyle risk factors, such as smoking, drinking behaviour and regular intake of analgesics and laxatives. The study includes 647 hospital-based incident cases with bladder cancer (n = 571), renal pelvis cancer (n = 51), and ureter cancer (n = 25), and 647 population-based controls which were matched individually by sex and age.