Current Drug Safety - Volume 3, Issue 2, 2008

We consider the management of safety signals that arise in the context of endpoint trials. Such trials have design features which permit the detection of signals that otherwise may be missed in more traditional settings. However, the approaches that are typically employed to address them are less than satisfactory in terms of both the analytical techniques and the communication of the findings. In this paper, alternati Read More

Infections are relevant complications that cause morbidity in solid organ transplantation and autoimmune diseases. Infection represents a leading single cause of death in these patients. Identification of patients at risk for development of infections and specific intervention to decrease infection risk might lead to better outcomes, though one needs first to evaluate the presence of risk factors for infection. Underlying disease itself Read More

As part of the intensive efforts in facilitating drug discovery, computational methods have been explored as low-cost and efficient tools for predicting various toxicological properties and adverse drug reactions (ADR) of pharmaceutical agents. More recently, machine learning methods have been applied for developing tools capable of predicting diverse spectrum of compounds of different toxicological properties and A Read More

The recognition, management, and if possible prevention, of major cardiovascular, central nervous system, haematological, and metabolic adverse effects, including diabetes mellitus and weight gain, of antipsychotics and some other drugs used to treat mental illness is a topic of much debate. However, a wide range of other adverse effects, some of which may be life-threatening, may also be encountered. Side-effects reviewe Read More

Purpose: To estimate the rate of new-onset seizure in ADHD patients in relation to ADHD pharmacotherapy. Methods: A retrospective cohort study of 34,727 patients, ages 6 to 17, with at least two insurance claims bearing ADHD diagnoses during 2003 in the United Healthcare database. Incidence of seizure was calculated for observation time during treatment with atomoxetine and stimulants/bupropion. Results: Seizure i Read More

Objective: Review nonclinical and clinical trial data for hepatic effects of duloxetine. Methods: Review studies of toxicology, metabolism, mitochondrial effects, and clinical trials. Results: Nonclinical studies revealed no treatment-related transaminase elevations and no effects of duloxetine on mitochondrial beta-oxidation in rat hepatocytes. In patients with a normal baseline alanine transaminase (ALT), duloxetine Read More

Objective: Review spontaneous reports and epidemiology of hepatic events associated with duloxetine. Methods: Spontaneous reports of adverse events potentially associated with hepatic injury were identified. Classification schemes were Clinical Significance and Etiologic Category relative to likelihood of being related to duloxetine. Results: Duloxetine has been taken by an estimated 5,083,000 patients, representing approxim Read More

Objective: Present results from two hepatic safety studies conducted within 20 months after duloxetine launch. Methods: Signal detection based on spontaneous reports to the FDA adverse event reporting system (AERS) and on a comparison of duloxetine and venlafaxine in the i3 Drug Safety Aperio claims database, using measures of disproportionality and incidence rate ratio, respectively. Results: In AERS all antidepressants Read More

The objective of the study is to assess the frequency and comprehensiveness of laboratory monitoring of hematological and hepatic parameters in ambulatory Nigerian hypertensive patients on methyldopa therapy. A retrospective cross sectional study was conducted between 1st February and 31st March 2007 at the Medical Outpatient Clinic of a 900-bed premier teaching hospital located in Ibadan, Nigeria. 260 case notes of hy Read More