PURPOSE Current guidelines recommend α1-adrenoreceptor blockers (A1Bs) for treating lower urinary tract symptoms suggestive of benign prostatic hyperplasia, but their adverse effects can be problematic. In this study, reports submitted to the US Food and Drug Administration Adverse Event Reporting System (FAERS) between 1997 and 2011 were reviewed to assess the safety profiles of A1Bs. METHOD...

We have evaluated the reporting of withdrawals due to adverse effects and specific adverse effects in randomised controlled trials of recombinant human GH in adults. A systematic review was carried out of randomised controlled trials of the clinical effectiveness of recombinant human GH in adults with GH deficiency in relation to impact on quality of life. Trials were identified from searching ...

BACKGROUND This is a continued examination of 10 years of prospectively collected Florida in-office adverse event data and new comparable data from mandatory Alabama in-office adverse event data reporting. OBJECTIVE To determine which office surgical procedures have resulted in reported complications. METHODS This study is a compilation of mandatory reporting of office surgical complication...

Since 1966, the Advisory Committee on Immunization Practices (ACIP) has recommended tetanus-diphtheria toxoid (Td) be used instead of single antigen tetanus toxoid (TT) because, while both vaccines protect against tetanus, only Td protects against diphtheria. Despite this recommendation, approximately 2.5 million doses of TT were distributed annually from 1991 to 1997. One possible explanation ...

OBJECTIVE To determine the extent and nature of selective non-reporting of harm outcomes in clinical studies that were eligible for inclusion in a cohort of systematic reviews. DESIGN Cohort study of systematic reviews from two databases. SETTING Outcome reporting bias in trials for harm outcomes (ORBIT II) in systematic reviews from the Cochrane Library and a separate cohort of systematic ...

There has been considerable under-reporting of drug and radiopharmaceutical interactions, security and adverse reactions. The increasing use of radiopharmaceuticals has come to the attention of nuclear medicine staff and regulatory bodies. The aim is to provide reference for adverse reactions which could help all nuclear medicine staff in their daily routine. Reporting adverse events, including...