Teriparatide Did Not Increase Adult Osteosarcoma Incidence in a 15‐Year US Postmarketing Surveillance Study

The US Postmarketing Surveillance Study of Adult Osteosarcoma and Teriparatide: Study Design and Findings From the First 7 Years

The Osteosarcoma Surveillance Study, an ongoing 15-year surveillance study initiated in 2003, is a postmarketing commitment to the United States (US) Food and Drug Administration to evaluate a potential association between teriparatide, rhPTH(1-34), a recombinant human parathyroid hormone analog (self-injectable medication to treat osteoporosis), and development of osteosarcoma in response to a...

Postmarketing Safety Study Tool: A Web Based, Dynamic, and Interoperable System for Postmarketing Drug Surveillance Studies

Postmarketing drug surveillance is a crucial aspect of the clinical research activities in pharmacovigilance and pharmacoepidemiology. Successful utilization of available Electronic Health Record (EHR) data can complement and strengthen postmarketing safety studies. In terms of the secondary use of EHRs, access and analysis of patient data across different domains are a critical factor; we addr...

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...

Did a severe flood in the Midwest cause an increase in the incidence of gastrointestinal symptoms?

Severe flooding occurred in the midwestern United States in 2001. Since November 2000, coincidentally, data on gastrointestinal symptoms had been collected for a drinking water intervention study in a community along the Mississippi River that was affected by the flood. After the flood had subsided, the authors asked these subjects (n = 1,110) about their contact with floodwater. The objectives...