Format
Sort by

Send to

Choose Destination

Links from PubMed

Items: 1 to 20 of 133

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.

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
4.

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.

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.

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
7.

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
8.

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
9.

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
10.

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
11.

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
12.
13.

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.

PMID:
23480866
14.

FDA boxed warnings: how to prescribe drugs safely.

O'Connor NR.

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

15.

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
16.

Preventing postmarketing changes in recommended doses and marketing withdrawals.

Peck C.

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

PMID:
17117726
17.

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
18.

Messages about black-box warnings: a comparative analysis of reports from the FDA and lay media in the US.

Yong PL, Bigman C, Flynn DN, Mittermaier D, Long JA.

Drug Saf. 2009;32(12):1147-57. doi: 10.2165/11318960-000000000-00000.

PMID:
19916582
19.

An analysis of legal warnings after drug approval in Thailand.

Sriphiromya P, Theeraroungchaisri A.

Regul Toxicol Pharmacol. 2015 Feb;71(1):108-13. doi: 10.1016/j.yrtph.2014.10.013. Review.

PMID:
25445000
20.

A decade of safety-related regulatory action in the Netherlands: a retrospective analysis of direct healthcare professional communications from 1999 to 2009.

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

Drug Saf. 2010 Jun 1;33(6):463-74. doi: 10.2165/11532840-000000000-00000.

PMID:
20486729
Items per page

Supplemental Content

Support Center