Postmarketing surveillance of injury countermeasures.

Postmarketing surveillance of injury countermeasures.

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...

Rivaroxaban postmarketing risk of liver injury.

BACKGROUND & AIMS Rivaroxaban is an oral direct factor Xa inhibitor that has been marketed worldwide since 2008 for the primary and secondary prevention and treatment of thromboembolic disorders. Although liver injury was observed in premarketing trials of rivaroxaban, there are no published postmarketing cases of liver injury associated with rivaroxaban. METHODS Report of 14 cases of liver i...

Postmarketing Surveillance of the Safety and Effectiveness of Etanercept in

Objective. Postmarketing surveillance (PMS) was conducted evaluating safety and effectiveness of etanercept (ETN; Enbrel®) in Japan, following all patients with rheumatoid arthritis (RA) during the conditional approval period of ETN. Methods. Registration of patients from 1,334 medical sites was conducted between March 2005 and April 2007. Patients were followed for 24 weeks; data regarding pat...