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of 6
pro vyhledávání: '"Colin B. Erdman"'
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
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
Publikováno v:
Drug Safety
Neuropsychiatric adverse effects of oseltamivir in the FDA Adverse Event Reporting System, 1999-2012
Publikováno v:
BMJ. 347:f4656-f4656
Publications from Roche and a case-control study suggest that there is no evidence, or plausible mechanism of action, to link neuropsychiatric adverse events to Tamiflu (oseltamivir).1 2 Cochrane Collaborators, the BMJ , and others, however, contend