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Items: 1 to 20 of 184

1.

Timing of new black box warnings and withdrawals for prescription medications.

Lasser KE, Allen PD, Woolhandler SJ, Himmelstein DU, Wolfe SM, Bor DH.

JAMA. 2002 May 1;287(17):2215-20.

PMID:
11980521
2.

Era of faster FDA drug approval has also seen increased black-box warnings and market withdrawals.

Frank C, Himmelstein DU, Woolhandler S, Bor DH, Wolfe SM, Heymann O, Zallman L, Lasser KE.

Health Aff (Millwood). 2014 Aug;33(8):1453-9. doi: 10.1377/hlthaff.2014.0122.

PMID:
25092848
3.

Drug-review deadlines and safety problems.

Carpenter D, Zucker EJ, Avorn J.

N Engl J Med. 2008 Mar 27;358(13):1354-61. doi: 10.1056/NEJMsa0706341.

4.

Risk management policy and black-box warnings: a qualitative analysis of US FDA proceedings.

Cook DM, Gurugubelli RK, Bero LA.

Drug Saf. 2009;32(11):1057-66. doi: 10.2165/11316670-000000000-00000.

PMID:
19810777
5.

Safety-related regulatory actions for biologicals approved in the United States and the European Union.

Giezen TJ, Mantel-Teeuwisse AK, Straus SM, Schellekens H, Leufkens HG, Egberts AC.

JAMA. 2008 Oct 22;300(16):1887-96. doi: 10.1001/jama.300.16.1887.

PMID:
18940975
6.

Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals.

Schick A, Miller KL, Lanthier M, Dal Pan G, Nardinelli C.

Drug Saf. 2017 Jun;40(6):497-503. doi: 10.1007/s40264-017-0526-1.

PMID:
28342075
7.

How the FDA manages drug safety with black box warnings, use restrictions, and drug removal, with attention to gastrointestinal medications.

Ehrenpreis ED, Ciociola AA, Kulkarni PM; FDA-Related Matters Committee of the American College of Gastroenterology.

Am J Gastroenterol. 2012 Apr;107(4):501-4. doi: 10.1038/ajg.2011.449. No abstract available.

PMID:
22475958
8.

Ethical and Practical Considerations in Removing Black Box Warnings from Drug Labels.

Yeh JS, Sarpatwari A, Kesselheim AS.

Drug Saf. 2016 Aug;39(8):709-14. doi: 10.1007/s40264-016-0419-8.

PMID:
27000800
9.

New and incremental FDA black box warnings from 2008 to 2015.

Solotke MT, Dhruva SS, Downing NS, Shah ND, Ross JS.

Expert Opin Drug Saf. 2018 Feb;17(2):117-123. doi: 10.1080/14740338.2018.1415323. Epub 2017 Dec 17.

PMID:
29215916
10.

Impact of United States Food and Drug Administration's boxed warnings on adverse drug reactions reporting rates and risk mitigation for multiple myeloma drugs.

Garg V, Raisch DW, McKoy JM, Trifilio SM, Holbrook J, Edwards BJ, Belknap SM, Samaras AT, Nardone B, West DP.

Expert Opin Drug Saf. 2013 May;12(3):299-307. doi: 10.1517/14740338.2013.780024. Epub 2013 Mar 12.

PMID:
23480866
11.

Safety of newly approved drugs: implications for prescribing.

Temple RJ, Himmel MH.

JAMA. 2002 May 1;287(17):2273-5. No abstract available.

PMID:
11980528
12.

Black box warnings: what do they mean to pharmacists and patients.

Martin CM, Borgelt L.

Consult Pharm. 2012 Jul;27(7):482-92. doi: 10.4140/TCP.n.2012.482.

PMID:
22910129
13.

Adverse drug reactions in elderly patients: alternative approaches to postmarket surveillance.

Noah BA, Brushwood DB.

J Health Law. 2000 Summer;33(3):383-454.

PMID:
11184355
14.

Impact of safety-related regulatory action on clinical practice: a systematic review.

Piening S, Haaijer-Ruskamp FM, de Vries JT, van der Elst ME, de Graeff PA, Straus SM, Mol PG.

Drug Saf. 2012 May 1;35(5):373-85. doi: 10.2165/11599100-000000000-00000. Review.

PMID:
22480319
15.

Safety-related regulatory actions for orphan drugs in the US and EU: a cohort study.

Heemstra HE, Giezen TJ, Mantel-Teeuwisse AK, de Vrueh RL, Leufkens HG.

Drug Saf. 2010 Feb 1;33(2):127-37. doi: 10.2165/11319870-000000000-00000.

PMID:
20082539
16.
17.

FDA boxed warnings: how to prescribe drugs safely.

O'Connor NR.

Am Fam Physician. 2010 Feb 1;81(3):298-303. Review.

18.

Dissemination of information on potentially fatal adverse drug reactions for cancer drugs from 2000 to 2002: first results from the research on adverse drug events and reports project.

Ladewski LA, Belknap SM, Nebeker JR, Sartor O, Lyons EA, Kuzel TC, Tallman MS, Raisch DW, Auerbach AR, Schumock GT, Kwaan HC, Bennett CL.

J Clin Oncol. 2003 Oct 15;21(20):3859-66. Erratum in: J Clin Oncol. 2004 Mar 15;22(6):1169.

PMID:
14551305
19.

Preventing postmarketing changes in recommended doses and marketing withdrawals.

Peck C.

Ernst Schering Res Found Workshop. 2007;(59):209-16. Review.

PMID:
17117726
20.

Adherence to black box warnings for prescription medications in outpatients.

Lasser KE, Seger DL, Yu DT, Karson AS, Fiskio JM, Seger AC, Shah NR, Gandhi TK, Rothschild JM, Bates DW.

Arch Intern Med. 2006 Feb 13;166(3):338-44.

PMID:
16476875

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