Postmarketing surveillance: practical experience with ketotifen.

Postmarketing surveillance of injury countermeasures.

Complications with axial presacral lumbar interbody fusion: A 5-year postmarketing surveillance experience

BACKGROUND Open and minimally invasive lumbar fusion procedures have inherent procedural risks, with posterior and transforaminal approaches resulting in significant soft-tissue injury and the anterior approach endangering organs and major blood vessels. An alternative lumbar fusion technique uses a small paracoccygeal incision and a presacral approach to the L5-S1 intervertebral space, which a...

Postmarketing surveillance for drug abuse.

Assessing actual abuse of prescribed medications requires postmarketing surveillance. In this article we discuss general systems of postmarketing surveillance that exist as of the end of 2002 in the United States and two medication-specific surveillance systems that were devised and tested. The two specific surveillance systems are compared with limitations highlighted. Postmarketing surveillan...

Postmarketing surveillance of adverse reactions to drugs.

Three highly publicised outbreaks of iatrogenic disease have affected Britain in the past 20 years. The thalidomide affair resulted in legal controls on the investigation and marketing of new pharmaceutical products; the practolol episode produced a prolonged period of introspection but no further legislative action; and the problems with benoxaprofen should herald a re-evaluation of our curren...

Sucrose-Formulated Recombinant Factor VIII Dosing Flexibility in Prophylaxis Regimens: Experience from Postmarketing Surveillance Studies

Objectives. Prophylaxis regimens for severe hemophilia A allowing more flexible dosing while maintaining efficacy may improve adherence and decrease the cost of prophylaxis. Here, we compared the clinical effectiveness of once- or twice-weekly versus ≥3-times-weekly prophylaxis with sucrose-formulated recombinant factor VIII (rFVIII-FS) in a "real-world" practice setting. Methods. Data from 3 p...