rosiglitazone (Avandia)

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Introduction

Tradename: Avandia. Medication Guide to be provided with each prescription

Indications

Contraindications

(cautions)

pregnancy category = c

safety in lactation = -

Dosage

Tabs: 2, 4, 8 mg

Pharmacokinetics

elimination via liver

1/2life = 103-158 hours

protein binding = 99.8 %

Monitor

  • LFTs at start, then every 2 months for 1st year, then periodically
  • discontinue if AST > 2.5 x upper limit of normal

Adverse effects

Drug interactions

Mechanism of action

* PPAR: peroxisome proliferator-activated receptor

More general terms

Additional terms

Component of

References

  1. ↑ Kaiser Permanente Northern California Regional Drug Alert
  2. ↑ Kaiser Permanente Northern California Regional Drug Formulary, 2000
  3. ↑ Physician's Desk Reference (PDR) 54th edition, Medical Economics, 2000
  4. ↑ 4.0 4.1 4.2 Prescriber's Letter 8(10):58 2001
  5. ↑ Geriatric Dosage Handbook, 6th edition, Selma et al eds, Lexi-Comp, Cleveland, 2001
  6. ↑ 6.0 6.1 Prescriber's Letter 9(4):22 2002
  7. ↑ 7.0 7.1 7.2 7.3 Prescriber's Letter 10(4):20 2003
  8. ↑ 8.0 8.1 Journal Watch 23(24):189, 2003 Delea TE et al, Diabetes Care 26:2983, 2003 PMID: https://www.ncbi.nlm.nih.gov/pubmed/14578227
  9. ↑ 9.0 9.1 Prescriber's Letter 11(8):41 2004 Avandia and Actos for Psoriasis Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=200802&pb=PRL (subscription needed) http://www.prescribersletter.com
  10. ↑ 10.0 10.1 Prescriber's Letter 12(8): 2005 Does Actos Improve Lipids Better than Avandia? Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=210310&pb=PRL (subscription needed) http://www.prescribersletter.com
  11. ↑ Department of Veterans Affairs, VA National Formulary
  12. ↑ 12.0 12.1 FDA Medwatch http://www.fda.gov/medwatch/safety/2006/safety06.htm#Avandia
  13. ↑ 13.0 13.1 Prescriber's Letter 13(9): 2006 The Use of Glitazones in Patients with Congestive Heart Failure Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=220909&pb=PRL (subscription needed) http://www.prescribersletter.com
  14. ↑ 14.0 14.1 FDA Medwatch http://www.fda.gov/medwatch/safety/2007/safety07.htm#rosiglitazone
  15. ↑ 15.0 15.1 Nissen SE and Wolski K Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes. N Engl J Medwww.nejm.org May 21, 2007 (10.1056/NEJMoa072761) http://content.nejm.org/cgi/content/full/NEJMoa072761
    FDA MedWatch http://www.fda.gov/medwatch/safety/2007/safety07.htm#Avandia http://www.fda.gov/medwatch/safety/2007/safety07.htm#Avandia2 http://www.fda.gov/medwatch/safety/2008/safety08.htm#Avandia
  16. ↑ 16.0 16.1 Prescriber's Letter 14(6): 2007 Avandia and Risk of Heart Attack Information for Patients Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=230622&pb=PRL (subscription needed) http://www.prescribersletter.com
  17. ↑ Prescriber's Letter 14(7): 2007 Avandia and Risk of Heart Attack Information for Patients Avandia (Rosiglitazone) and the Risk of Myocardial Infarction Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=230718&pb=PRL (subscription needed) http://www.prescribersletter.com
  18. ↑ 18.0 18.1 18.2 Prescriber's Letter 14(12): 2007 FDA Adds Boxed Warning for Heart-related Risks to Avandia Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=231202&pb=PRL (subscription needed) http://www.prescribersletter.com
  19. ↑ Lago RM et al. Congestive heart failure and cardiovascular death in patients with prediabetes and type 2 diabetes given thiazolidinediones: A meta-analysis of randomised clinical trials. Lancet 2007 Sep 29; 370:1129. PMID: https://www.ncbi.nlm.nih.gov/pubmed/17905165
    Cleland JGF and Atkin SL. Thiazolidinediones, deadly sins, surrogates, and elephants. Lancet 2007 Sep 29; 370:1103. PMID: https://www.ncbi.nlm.nih.gov/pubmed/17905146
    Montori VM et al. Patient-important outcomes in diabetes - time for consensus. Lancet 2007 Sep 29; 370:1104. PMID: https://www.ncbi.nlm.nih.gov/pubmed/17905147
  20. ↑ 20.0 20.1 Lipscombe LL et al Thiazolidinediones and cardiovascular outcomes in older patients with diabetes. JAMA. 2007 Dec 12;298(22):2634-43. PMID: https://www.ncbi.nlm.nih.gov/pubmed/18073359
  21. ↑ FDA MedWatch http://www.fda.gov/medwatch/safety/2008/safety08.htm#Avandia
  22. ↑ 22.0 22.1 22.2 22.3 Home PD et al Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial The Lancet, Early Online Publication, 5 June 2009 doi:10.1016/S0140-6736(09)60953-3 http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(09)60953-3/fulltext
  23. ↑ 23.0 23.1 Loke Y et al Long-term use of thiazolidinediones and fractures in type 2 CMAJ. 2009 Jan 6;180(1):32-9. Epub 2008 Dec 10. PMID: https://www.ncbi.nlm.nih.gov/pubmed/19073651
  24. ↑ FDA MedWatch Avandia (rosiglitazone): Ongoing Review of Cardiovascular Safety http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm201446.htm
    FDA MedWatch Avandia (rosiglitazone): REMS - Risk of Cardiovascular Events [UPDATED 02/04/2011] http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm226994.htm
  25. ↑ Prescriber's Letter 17(3): 2010 COMMENTARY: Avandia and Cardiovascular Safety: Ongoing Review PATIENT HANDOUT: Avandia and Risk of Heart Attack PATIENT HANDOUT SPANISH VERSION: Avandia y el Riesgo de un Ataque Cardiaco Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=260325&pb=PRL (subscription needed) http://www.prescribersletter.com
  26. ↑ Prescriber's Letter 17(4): 2010 Avandia and Cardiovascular Safety: Ongoing Review COMMENTARY: Avandia and Cardiovascular Safety: Ongoing Review PATIENT HANDOUT: Avandia and Risk of Heart Attack Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=260402&pb=PRL (subscription needed) http://www.prescribersletter.com
  27. ↑ Nissen SE and Wolski K Rosiglitazone Revisited: An Updated Meta-analysis of Risk for Myocardial Infarction and Cardiovascular Mortality Arch Intern Med. 2010 170(14): PMID: https://www.ncbi.nlm.nih.gov/pubmed/20656674 doi:10.1001/archinternmed.2010.207 http://archinte.ama-assn.org/cgi/content/full/2010.207
    Graham DJ et al Risk of Acute Myocardial Infarction, Stroke, Heart Failure, and Death in Elderly Medicare Patients Treated With Rosiglitazone or Pioglitazone JAMA. 2010;304(4): PMID: https://www.ncbi.nlm.nih.gov/pubmed/20584880 doi:10.1001/jama.2010.920 http://jama.ama-assn.org/cgi/content/full/jama.2010.920
    Juurlink DN Rosiglitazone and the Case for Safety Over Certainty JAMA. 2010;304(4): PMID: https://www.ncbi.nlm.nih.gov/pubmed/20584879 doi:10.1001/jama.2010.954 http://jama.ama-assn.org/cgi/content/full/jama.2010.954
  28. ↑ Prescriber's Letter 17(7): 2010 Recommended Lab Monitoring for Common Medications Liver Function Test Scheduling Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=260704&pb=PRL (subscription needed) http://www.prescribersletter.com
  29. ↑ FDA Drug Safety Communication: Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone- containing Medicines including Avandia, Avandamet, and Avandaryl http://www.fda.gov/Drugs/DrugSafety/ucm255005.htm
  30. ↑ 30.0 30.1 Idris I et al Association Between Thiazolidinedione Treatment and Risk of Macular Edema Among Patients With Type 2 Diabetes Arch Intern Med. 2012;():1-7, June 2012 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/22688528 <Internet> http://archinte.jamanetwork.com/article.aspx?articleID=1182550
    Singh S and Segal JB Thiazolidinediones and Macular Edema: Comment on "Association Between Thiazolidinedione Treatment and Risk of Macular Edema Among Patients With Type 2 Diabetes" PMID: https://www.ncbi.nlm.nih.gov/pubmed/22688825
  31. ↑ 31.0 31.1 FDA MedWatch. Nov 25, 2013 Rosiglitazone-containing Diabetes Medicines: Drug Safety Communication - Removal of Some Prescribing and Dispensing Restrictions. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm376683.htm
    Tucker ME FDA Lifts Final Regulatory Restrictions on Rosiglitazone. Medscape. Dec 16, 2015 http://www.medscape.com/viewarticle/856056
  32. ↑ 32.0 32.1 Wallach JD, Wang K, Zhang AD et al Updating insights into rosiglitazone and cardiovascular risk through shared data: individual patient and summary level meta-analyses. BMJ 2020;368:l7078 PMID: https://www.ncbi.nlm.nih.gov/pubmed/32024657 Free Article https://www.bmj.com/content/368/bmj.l7078
  33. ↑ HIGHLIGHTS OF PRESCRIBING INFORMATION AVANDIA (rosiglitazone maleate) Tablets. https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021071s031lbl.pdf

Database

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