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Publication of case reports describing suspected adverse effects of drugs and medical products that include herbal and complementary medicines, vaccines, and other biologicals and devices is important for postmarketing surveillance. Publication lends credence to important signals raised in these adverse event reports. Unfortunately, deficiencies in vital information in published cases can often limit the value of such reports by failing to provide sufficient details for either (i) a differential diagnosis or provisional assessment of cause-effect association, or (ii) a reasonable pharmacological or biological explanation. Properly described, a published report of one or more adverse events can provide a useful signal of possible risks associated with the use of a drug or medical product which might warrant further exploration. A review conducted by the Task Force authors found that many major journals have minimal requirements for publishing adverse event reports, and some have none at all. Based on a literature review and our collective experience in reviewing adverse event case reports in regulatory, academic, and industry settings, we have identified information that we propose should always be considered for inclusion in a report submitted for publication. These guidelines have been endorsed by the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) and are freely available on the societies' web sites. Their widespread distribution is encouraged. ISPE and ISoP urge biomedical journals to adopt these guidelines and apply them to case reports submitted for publication. They also encourage schools of medicine, pharmacy, and nursing to incorporate them into the relevant curricula that address the detection, evaluation, and reporting of suspected drug or other medical product adverse events., (Copyright 2007 Kelly et al. Reproduced with permission by John Wiley & Sons, Ltd.)

Background: COX-2 and NSAIDS differ in their gastrointestinal (GI) and cardiovascular (CV) toxicity from pharmacological, clinical and epidemiologic point of views., Objective: Describe the patterns of use of NSAIDS and COX-2 in The Health Improvement Network (THIN) database in UK and the PharMetrics database in USA., Methods: We examined the experience of 10 distinct cohorts of new users of diclofenac, naproxen, ibuprofen, piroxicam, other NSAIDS, meloxicam, celecoxib, etoricoxib, rofecoxib and valdecoxib. The study period was 1 January 1995 through 2004 (31 March in UK and 28 February in USA). We collected information on covariates including history of upper GI disease, CV disease, hepatic disease, dosage, concomitant medication, and visits to a rheumatologist., Results: We identified 486 076 unique patient-drug pairs in UK and 1 533 239 in USA. In UK population 78 201 (16%) were COX-2 users and in PharMetrics 324 206 (21%) were COX-2 users. Diclofenac and ibuprofen (NSAIDS), and celecoxib and rofecoxib (COX-2) were the agents prescribed most frequently. The duration of therapy was longer among celecoxib and rofecoxib users than among other users. More COX-2 users than NSAIDS users received concomitant gastroprotective agents (GPA), corticosteroids and anti-platelet therapy, and had a history of thromboembolic events and hypertension. PharMetrics patients were prescribed higher doses of NSAIDS and COX-2. The use of any single agent for more than 90 days was uncommon, but more frequent in PharMetrics. Switching was uncommon and was generally to a NSAID., Discussion: Our results confirm some previous findings from other authors such as the presence of both GI and CV channelling to COX-2 agents but refute others, such as the frequency of drug switching between these agents. The typical use of COX-2 agents in practice is for shorter duration, and at lower doses, than was employed in randomized clinical trials. This difference may help clarify the apparent discrepancy with respect to CV toxicity between the results from clinical trials, which showed a higher CV risk with these drugs, and non-experimental epidemiologic studies, which showed lower or no increase in risk.

Background: Asthma and chronic obstructive pulmonary disease (COPD), defined as obstructive airways disease (OAD), are two common chronic conditions especially in the elderly. Glaucoma is also a common disease in the elderly with a prevalence close to 5% among those older than 75 years. Most medical therapy for glaucoma is given as eye drops. It has been described that small amounts of systemically absorbed beta-blockers can produce significant respiratory adverse events in predisposed patients., Methods: Population-based cohort study with nested case-control analysis using the UK General Practice Research Database (GPRD). We studied the prevalence of OAD in a cohort of patients 60 to 85 years old with a first ever diagnosis of glaucoma and compared it to the prevalence in an age- and sex-matched cohort sampled from the general population. We also calculated the RR and 95% CI of worsening asthma in non-severe asthma patients among the two cohorts. Incidence of OAD was studied in a cohort of glaucoma patients 60 to 85 years old and in an age- and sex-matched cohort from the general population., Results: The prevalence of OAD was the same between the glaucoma cohort and the general population (OR 1.1; 95% CI 0.9-1.4). The risk of worsening asthma associated with glaucoma was OR 1.2 (95% CI 0.5-2.8). The incidence of OAD was similar in both cohorts. Current users of ophthalmic drugs presented a RR of 1.2 (95% CI 0.8-1.9) of developing asthma compared to non-users in the glaucoma population. The risk in the first month of treatment with topical beta-blockers was 2.1 (95% CI 0.7-6.7)., Discussion: We did not find an association between glaucoma and OAD. Use of topical glaucoma medication was not associated with a major increased risk of asthma.