An Alternative to Disproportionality: A Frequency-Based Method for Pharmacovigilance Data Mining.

Background: Safety surveillance relies on mining of large pharmacovigilance (PV) databases to generate insights regarding the safe use of pharmaceutical products. The predominant approach to PV data mining involves computation of disproportionality scores for drug-adverse event (drug-AE) pairs. However, this approach requires a database to be sufficiently large, sufficiently diverse for the analysis to be reliably sensitive and specific, and fails to consider the particular safety profile of a product.

Does Ad Hoc Coronary Intervention Reduce Radiation Exposure? - Analysis of 568 Patients.

Background: Advantages and disadvantages of ad hoc percutaneous coronary intervention have been described. However little is known about the radiation exposure of that procedure as compared with the staged intervention.

Objective: To compare the radiation dose of the ad hoc percutaneous coronary intervention with that of the staged procedureMethods:The dose-area product and total Kerma were measured, and the doses of the diagnostic and therapeutic procedures were added.

Current advances in pharmacovigilance in the USA and Europe: meeting the challenges of safety monitoring in HIV.

Purpose Of Review: The success of antiretroviral therapy in HIV disease comes currently with the realization that patients are committed to life-long treatment, which raises the possibility of long-term toxicity. Such long-term side effects may not be identified in initial clinical trials requiring, therefore, a different approach to monitoring patients over time - a pharmacovigilance approach.

Recent Findings: Several key issues in long-term management of HIV infection have been addressed by a pharmacovigilance approach - including unusual and rare side effects and elucidation of emerging toxicities such as cardiovascular, bone and renal disease.

Emergency use authorization for intravenous peramivir: evaluation of safety in the treatment of hospitalized patients infected with 2009 H1N1 influenza A virus.

Background: On 23 October 2009, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for intravenous peramivir, an unapproved antiviral, to treat suspected or confirmed 2009 H1N1 influenza A virus infection. Eligible hospitalized patients were unresponsive to or unable to tolerate available antivirals or lacked dependable oral or inhaled drug delivery routes. The EUA required healthcare providers to report medication errors, selected adverse events (AEs), serious AEs, and deaths to the FDA.

CABG late angiographic grafting patency analysis in patients with recurrent symptoms.

Objective: Left internal thoracic artery (LITA) grafting has become the gold standard in coronary artery bypass graft procedure (CABG). In order to optimize the use of LITA or other grats, sequential anastomosis has been used. There is no consensus on equivalence of results between isolated and sequential grafts.