Zobrazeno 1 - 10
of 29
pro vyhledávání: '"Keith B Hoffman"'
Publikováno v:
PLoS ONE, Vol 7, Iss 8, p e42866 (2012)
BACKGROUND: Cholesterol management drugs known as statins are widely used and often well tolerated; however, a variety of muscle-related side effects can arise. These adverse events (AEs) can have serious impact, and form a significant barrier to the
Externí odkaz:
https://doaj.org/article/e0a0201c996a455ba5a659d3de16dd82
Autor:
Matthew S. Duprey, Keith B. Hoffman, Christopher Madias, Mo Dimbil, Nada S. Al-Qadheeb, Jonathan Weinstock, John W. Devlin, Nick O'Donnell
Publikováno v:
Drugs-Real World Outcomes, Vol 6, Iss 3, Pp 141-149 (2019)
Drugs-Real World Outcomes
Drugs-Real World Outcomes
Background Serious cardiovascular adverse events (SCAEs) associated with intravenous sedatives remain poorly characterized. Objective The objective of this study was to compare SCAE incidence, types, and mortality between intravenous benzodiazepines
Publikováno v:
Drug Safety. 41:357-361
The Janus kinase (JAK) inhibitor baricitinib is approved in Europe and Japan for the treatment of rheumatoid arthritis. In April 2017, the US FDA expressed concern about thromboembolic events (deep venous thrombosis [DVT] and pulmonary embolism [PE])
Publikováno v:
Drug Safety. 39:561-575
Many serious drug adverse events (AEs) only manifest well after regulatory approval. Therefore, the development of signaling methods to use with post-approval AE databases appears vital to comprehensively assess real-world drug safety. However, with
Publikováno v:
Drug safety. 41(4)
Apparent elevations in reporting of amyotrophic lateral sclerosis (ALS)-like conditions associated with statin use have been previously described from data obtained via US and European databases. The aim of this study was to examine US FDA Adverse Ev
Publikováno v:
Drug Safety
Background The US Food and Drug Administration (FDA) uses the Adverse Event Reporting System (FAERS) to support post-marketing safety surveillance programs. Currently, almost one million case reports are submitted to FAERS each year, making it a vast
Publikováno v:
Critical Care Medicine. 40:1-328
Autor:
Nicholas P. Tatonetti, Mo Dimbil, Keith B. Hoffman, Colin B. Erdman, Andrea Demakas, Robert F. Kyle, Brian M. Overstreet, Dingguo Chen
Publikováno v:
Journal of managed carespecialty pharmacy. 21(12)
Given the multiple limitations associated with relatively homogeneous preapproval clinical trials, inadequate data disclosures, slow reaction times from regulatory bodies, and deep-rooted bias against disclosing and publishing negative results, there
Publikováno v:
Drug Safety
Background The United States Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS) consists of adverse event (AE) reports linked to approved drugs. The database is widely used to support post-marketing safety surveillance prog
Publikováno v:
BMJ (Clinical research ed.). 348
Anticoagulants are some of the most widely used drugs worldwide. Dabigatran is commonly assumed to be safer than warfarin, but because debate continues on this question,1 we analysed post-marketing safety signals across this drug class. Drug safety a