An observational cohort study investigating the cardiovascular safety of tadalafil when prescribed in primary care in England: mortality due to ischaemic heart disease.

Objective: To examine the cardiovascular safety of tadalafil, a phosphodiesterase type-5 inhibitor used for treating erectile dysfunction in patients prescribed this drug by general practitioners (GPs) in England in 2003, focusing on mortality due to ischaemic heart disease (IHD).

Patients And Methods: Patients in this observational cohort study were identified from dispensed prescriptions for tadalafil issued by GPs from February to November 2003. Demographic and outcome data were requested from patients' GPs using a postal questionnaire.

Comparison of the risk of drowsiness and sedation between levocetirizine and desloratadine: a prescription-event monitoring study in England.

Background And Objectives: Desloratadine and levocetirizine are histamine H(1) receptor antagonists (antihistamines) that were launched in the UK in 2001. Our objective was to compare the frequency with which drowsiness and sedation were reported for desloratadine and levocetirizine within the first 30 days of observation, as monitored using the observational cohort technique of prescription-event monitoring (PEM).

Methods: Exposure data were derived from dispensed prescriptions written by primary care physicians and outcome data were derived from questionnaires that were posted to prescribers at least 6 months after the date of the first prescription for each patient.

Serious skin reactions and selective COX-2 inhibitors: a case series from prescription-event monitoring in England.

Background: The erythema multiforme (EM) spectrum of bullous eruptions (toxic epidermal necrolysis [TEN] and Stevens-Johnson syndrome [SJS]) are rare and serious skin reactions that have been reported for cyclo-oxygenase (COX)-2 selective inhibitors. Our objectives were to identify and describe cases of serious skin reactions reported during postmarketing studies of COX-2 selective inhibitors.

Methods: A retrospective review of information from reports of serious skin reactions reported during prescription-event monitoring (PEM) studies of rofecoxib, celecoxib, etoricoxib and valdecoxib conducted in England since 1999.

Examination of the safety and use of apomorphine prescribed in general practice in England as a treatment for erectile dysfunction.

Objective: To examine the safety and use of apomorphine as prescribed in general medical practice in England as a treatment for erectile dysfunction (ED).

Patients And Methods: Apomorphine hydrochloride (marketed as Uprima, Abbott Laboratories Ltd, UK) is licensed in the UK as a sublingual therapy for ED. It is the first treatment for ED with a central mode of action.

Pregnancy outcome of women exposed to bupropion during pregnancy: a prospective comparative study.

Objective: Bupropion was developed for the treatment of depression, but subsequently was found to be effective for smoking cessation. To date, there are no prospective comparative studies examining its safety in pregnancy. The primary objective was to determine whether bupropion increases the risks for major malformations above baseline.

Evaluation of the safety of bupropion (Zyban) for smoking cessation from experience gained in general practice use in England in 2000.

Background: Bupropion (Zyban) is the first new pharmacological treatment for smoking cessation to be introduced since nicotine replacement therapy. In smoking cessation trials, it has been associated with minimal side effects. A range of suspected adverse drug reactions (ADRs) were reported via the spontaneous reporting system following its use in smoking cessation.