Search Results - "Dimbil, Mo"

Analysis of Spontaneous Postmarket Case Reports Submitted to the FDA Regarding Thromboembolic Adverse Events and JAK Inhibitors by Verden, Abril, Dimbil, Mo, Kyle, Robert, Overstreet, Brian, Hoffman, Keith B.

“…Introduction The Janus kinase (JAK) inhibitor baricitinib is approved in Europe and Japan for the treatment of rheumatoid arthritis. In April 2017, the US FDA…”
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The Weber Effect and the United States Food and Drug Administration’s Adverse Event Reporting System (FAERS): Analysis of Sixty-Two Drugs Approved from 2006 to 2010 by Hoffman, Keith B., Dimbil, Mo, Erdman, Colin B., Tatonetti, Nicholas P., Overstreet, Brian M.

“…Background The United States Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS) consists of adverse event (AE) reports linked to…”
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A survey of the FDA's AERS database regarding muscle and tendon adverse events linked to the statin drug class by Hoffman, Keith B, Kraus, Christina, Dimbil, Mo, Golomb, Beatrice A

“…Cholesterol management drugs known as statins are widely used and often well tolerated; however, a variety of muscle-related side effects can arise. These…”
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Stimulated Reporting: The Impact of US Food and Drug Administration-Issued Alerts on the Adverse Event Reporting System (FAERS) by Hoffman, Keith B., Demakas, Andrea R., Dimbil, Mo, Tatonetti, Nicholas P., Erdman, Colin B.

“…Background The US Food and Drug Administration (FDA) uses the Adverse Event Reporting System (FAERS) to support post-marketing safety surveillance programs…”
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A Pharmacovigilance Signaling System Based on FDA Regulatory Action and Post-Marketing Adverse Event Reports by Hoffman, Keith B., Dimbil, Mo, Tatonetti, Nicholas P., Kyle, Robert F.

“…Introduction Many serious drug adverse events (AEs) only manifest well after regulatory approval. Therefore, the development of signaling methods to use with…”
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Serious Cardiovascular Adverse Events Reported with Intravenous Sedatives: A Retrospective Analysis of the MedWatch Adverse Event Reporting System by Duprey, Matthew S., Al-Qadheeb, Nada S., O’Donnell, Nick, Hoffman, Keith B., Weinstock, Jonathan, Madias, Christopher, Dimbil, Mo, Devlin, John W.

“…Background Serious cardiovascular adverse events (SCAEs) associated with intravenous sedatives remain poorly characterized. Objective The objective of this…”
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I41 Post-marketing adverse events (AES) associated with tetrabenazine (TBZ): findings using FDA’s adverse event reporting system (FAERS) by Claassen, Daniel O, Iyer, Ravi, Dimbil, Mo, Giron, Abril, De Boer, Lisa, Gandhi, Sanjay, Hoffman, Keith B

“…BackgroundIn clinical trials of patients with Huntington’s disease (HD), treatment with TBZ resulted in more neuropsychiatric AEs compared to placebo,…”
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Erratum to: The Weber Effect and the United States Food and Drug Administration’s Adverse Event Reporting System (FAERS): Analysis of Sixty-Two Drugs Approved from 2006 to 2010 by Hoffman, Keith B., Dimbil, Mo, Erdman, Colin B., Tatonetti, Nicholas P., Overstreet, Brian M.

“…K. B. Hoffman (&) ^ M. Dimbil ^ C. B. Erdman ^ B. M. Overstreet AdverseEvents, Inc., 3663 N. Laughlin Road, Suite 102, Santa Rosa, CA 95403, USA e-mail:…”
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A Drug Safety Rating System Based on Postmarketing Costs Associated with Adverse Events and Patient Outcomes by Hoffman, Keith B, Dimbil, Mo, Kyle, Robert F, Tatonetti, Nicholas P, Erdman, Colin B, Demakas, Andrea, Chen, Dingguo, Overstreet, Brian M

“…Given the multiple limitations associated with relatively homogeneous preapproval clinical trials, inadequate data disclosures, slow reaction times from…”
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Neuropsychiatric adverse effects of oseltamivir in the FDA Adverse Event Reporting System, 1999-2012 by Hoffman, Keith B, Demakas, Andrea, Erdman, Colin B, Dimbil, Mo, Doraiswamy, P Murali

“…1 2 Cochrane Collaborators, the BMJ, and others, however, contend that many of Roche's data remain unavailable. 3 We examined neuropsychiatric adverse events…”
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Neuropsychiatric adverse effects in FDA reporting system by Hoffman, Keith B, Demakas, Andrea, Erdman, Colin B, Dimbil, Mo, Doraiswamy, P Murali

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Post-approval adverse events of new and old anticoagulants by Hoffman, Keith B, Demakas, Andrea, Erdman, Colin B, Dimbil, Mo

“…2 These groupings help improve signal detection from adverse event case reports contained in the Food and Drug Administration's Adverse Event Reporting System…”
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