Stimulated Reporting: The Impact of US Food and Drug Administration-Issued Alerts on the Adverse Event Reporting System (FAERS)
نویسندگان
چکیده
منابع مشابه
Stimulated Reporting: The Impact of US Food and Drug Administration-Issued Alerts on the Adverse Event Reporting System (FAERS)
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 repository of drug safety information. Sometimes cited as a limitation of FAERS, however, is the assumption that "stimulated reporting" of adverse...
متن کاملOsteonecrosis of the Jaw in the United States Food and Drug Administration's Adverse Event Reporting System (FAERS).
Osteonecrosis of the jaw (ONJ) is a serious adverse drug event that was initially reported with intravenous bisphosphonates (BPs) and more recently with other classes of drugs such as receptor activator of NF-κB ligand (RANKL) inhibitor, antiangiogenic agents, and mammalian target of rapamycin (m-TOR) inhibitors. The purpose of this study is to analyze the ONJ cases and the associated drugs in ...
متن کاملMortality and oral anticoagulants in the Food and Drug Administration Adverse Event Reporting System
OBJECTIVE The comparative crude death rates (CDR) among non-vitamin K antagonist oral anticoagulants (NOACs) are unknown. Further, whether NOACs improve survival when compared with warfarin is also unclear. We compared CDR co-reported for four NOACs combined or separately versus warfarin within the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database. METHODS ...
متن کاملKerman Health System Workers Knowledge and Attitudes Regarding the Spontaneous Reporting System for Adverse Drug Reactions
Adverse drug reaction (ADR) is one of the most life threatening problems, and the economic burden of ADR is considerable. The main objective of this study was to assess the attitude of the Kerman health system staff, to evaluate their knowledge of the spontaneous reporting system and to identify the reasons for low reporting rate. In this descriptive study, a Persian translated questio...
متن کاملThe Vaccine Adverse Event Reporting System (VAERS).
Immunizations against most vaccine-preventable diseases will be needed indefinitely unless the disease is eradicated. Public acceptance of immunizations may be threatened as vaccine coverage increases and disease decreases, however, due to the increase in both causally and coincidentally related vaccine adverse events. The post-marketing surveillance for such events in the USA in response to th...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: Drug Safety
سال: 2014
ISSN: 0114-5916,1179-1942
DOI: 10.1007/s40264-014-0225-0