Rosiglitazone and implications for pharmacovigilance

British Medical Journal

Volumn 334, Issue 7606, 2007, Pages 1233-1234

  Kazi, Dhruv ^a  

^a LONDON SCHOOL OF ECONOMICS   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

METFORMIN; ROSIGLITAZONE; SULFONYLUREA; 2,4 THIAZOLIDINEDIONE DERIVATIVE; ANTIDIABETIC AGENT;

ANEMIA; CARDIOVASCULAR RISK; CLINICAL TRIAL; DRUG MECHANISM; DRUG MONITORING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG USE; EDITORIAL; FOOD AND DRUG ADMINISTRATION; GLYCEMIC CONTROL; HEART FAILURE; HEART INFARCTION; HUMAN; INSULIN SENSITIVITY; ISCHEMIA; META ANALYSIS; NON INSULIN DEPENDENT DIABETES MELLITUS; POSTMARKETING SURVEILLANCE; PRESCRIPTION; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; SIDE EFFECT; SYSTEMATIC REVIEW; UNITED STATES;

CLINICAL TRIALS; DIABETES MELLITUS, TYPE 2; HUMANS; HYPOGLYCEMIC AGENTS; META-ANALYSIS; PRODUCT SURVEILLANCE, POSTMARKETING; THIAZOLIDINEDIONES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 34250872761     PISSN: 09598146     EISSN: None     Source Type: Journal    
DOI: 10.1136/bmj.39245.502546.BE     Document Type: Editorial

References (14)

1. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascularcauses. N Engl J Med Published online 21 May 2007.
2. National Institute for Health and Clinical Excellence. NICE implementation uptake report: glitazones (rosiglitazone and pioglitazone). 2007. www.nice.org.uk/page.aspx?o=423524.
3. Eysenck HJ. Meta-analysis and its problems. BMJ 1994;309:789-92.
4. Home PD, Pocock SJ, Beck-Nielsen H, Gomis R, Hanefeld M, Jones N, et al. Rosiglitazone evaluated for cardiovascular outcomes - an interim analysis. N Engl J Med Published online 5 June 2007.
5. Psaty BM, Furberg CD. The record of rosiglitazone and the risk of myocardial infarction. N Engl J Med Published online 5 June 2007.
6. US Senate. Testimony of Bruce M Psaty, before the House Committee on Energyand Commerce subcommittee on oversight and investigations. 2007. http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.032207.Psaty-testimony.pdf.
7. Food and Drug Administration. Report on the performance of drug and biologic firms conducting postmarketing commitment studies; availability. Federal Register 2007;72:5069-70.
8. Gale EA. Lessons from the glitazones: a story of drug development. Lancet 2001;357:1870-5.
9. Nissen SE, Wolski K, Topol EJ. Effect of muraglitazar on death and major adverse cardiovascular events in patients with type 2 diabetes mellitus. JAMA 2005;294:2581-6.
10. GlaxoSmithKline. Study no. ZM2005/00181/01. Avandia cardiovascular event modeling project. http://ctr.gsk.co.uk/Summary/Rosiglitazone/ III_CVmodeling.pdf.
11. European MedicinesAgency. European public assessment report for authorised medicinal products for human use. Avandia. 2007. www.emea.europa.eu/humandocs/Humans/EPAR/avandia/avandia.html.
12. Psaty BM, Burke SP. Protecting the health of the public - Institute of Medicine recommendations on drug safety. N Engl J Med 2006;355:1753-5.
13. European Medicines Agency. Work programme for European Medicines Agency. London: EMEA, 2007:20-2.
14. Nathan DM. Rosiglitazone and cardiotoxicity - weighing the evidence. N Engl J Med Published online 5 June 2007.