Changes in prescribing and healthcare resource utilization after FDA Drug Safety Communications involving zolpidem-containing medications-Reference-Cited by-同舟云学术

Changes in prescribing and healthcare resource utilization after FDA Drug Safety Communications involving zolpidem-containing medications

Published:2017-04-27 Issue:6 Volume:26 Page:712-721
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Kesselheim Aaron S.¹^ORCID,Donneyong Macarius¹,Dal Pan Gerald J.²,Zhou Esther H.²,Avorn Jerry¹,Schneeweiss Sebastian¹,Seeger John D.¹

Affiliation:

1. Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine; Brigham and Women's Hospital and Harvard Medical School; Boston MA USA

2. Food and Drug Administration, Center for Drug Evaluation and Research (CDER); Office of Surveillance and Epidemiology (OSE); Boston MA USA

Funder

U.S. Food and Drug Administration

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/pds.4215/fullpdf

Reference31 articles.

1. Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012;Downing;JAMA,2014

2. Timing of new black box warnings and withdrawals for prescription medications;Lasser;JAMA,2002

3. Food and Drug Administration FDA Drug Safety Communication: abnormal heart rhythms associated with high doses of Celexa (citalopram hydrobromide) 2011 http://www.fda.gov/drugs/drugsafety/ucm269086.htm

4. Food and Drug Administration FDA Drug Safety Communication: new restrictions, contraindications, and dose limitations for Zocor (simvastatin) to reduce the risk of muscle injury 2011 http://www.fda.gov/drugs/drugsafety/ucm256581.htm

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3. The Use of Real‐World Data to Assess the Impact of Safety‐Related Regulatory Interventions;Clinical Pharmacology & Therapeutics;2021-11-18

4. Trend changes of national zolpidem users and exposure cases after FDA drug safety communications;Pharmacoepidemiology and Drug Safety;2021-08-23

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