Warnings without guidance: Patient responses to an fda warning about ezetimibe

Medical Care

Volumn 50, Issue 6, 2012, Pages 479-484

  Shrank, William H ^a,b   Choudhry, Niteesh K ^a   Tong, Angela ^b   Myers, Jessica ^b   Fischer, Michael A ^a   Swanton, Kellie ^b   Slezak, Julie ^c   Brennan, Troyen A ^c   Liberman, Joshua N ^c   Moffit, Susan ^d   Avorn, Jerry ^a   Carpenter, Daniel ^b  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b HARVARD UNIVERSITY   (United States)

^c CVS Caremark   (United States)

^d BROWN UNIVERSITY   (United States)

Author keywords

Adherence; FDA warning; Medication

Indexed keywords

EZETIMIBE; EZETIMIBE PLUS SIMVASTATIN; HYPOCHOLESTEROLEMIC AGENT;

ADULT; AGE DISTRIBUTION; AGED; ARTICLE; DRUG EFFICACY; DRUG INFORMATION; DRUG SUBSTITUTION; DRUG WITHDRAWAL; FEMALE; FOOD AND DRUG ADMINISTRATION; HUMAN; INCOME; MAJOR CLINICAL STUDY; MALE; MEDICAL INFORMATION; PATIENT ATTITUDE; PATIENT COMPLIANCE; PRIORITY JOURNAL; STATISTICAL ANALYSIS;

ADOLESCENT; ADULT; AGE FACTORS; AGED; AGED, 80 AND OVER; ANTICHOLESTEREMIC AGENTS; AZETIDINES; COHORT STUDIES; COMMUNICATION; CONSUMER PRODUCT SAFETY; DRUG UTILIZATION; FEMALE; GUIDELINES AS TOPIC; HUMANS; INSURANCE CLAIM REVIEW; MALE; MEDICATION ADHERENCE; MIDDLE AGED; SEX; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; YOUNG ADULT;

EID: 84862110303     PISSN: 00257079     EISSN: 15371948     Source Type: Journal    
DOI: 10.1097/MLR.0b013e31825517b6     Document Type: Article

References (19)

1. FDA. Early Communication about an Ongoing Data Review for Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor). Available at: http://www.fda.gov/Drugs/ DrugSafety/PostmarketDrugSafetyInformationfor PatientsandProviders/ DrugSafetyInformationforHeathcareProfessionals/ucm070779.htm. Accessed June 14, 2011.
2. Cheung A, Sacks D, Dewa CS, et al. Pediatric prescribing practices and the FDA black-box warning on antidepressants. J Dev Behav Pediatr. 2008;29:213-215.
3. Jacoby JL, Fulton J, Cesta M, et al. After the black box warning: dramatic changes in ED use of droperidol. Am J Emerg Med. 2005;23:196. (Pubitemid 40349225)
4. Ricci JA, Coulen C, Berger JE, et al. Prescriber compliance with black box warning in older adult patients. Am J Manag C. 2009;15: e103-e107.
5. Dorsey ER, Rabbani A, Gallagher SA, et al. Impact of FDA black box advisory on antipsychotic medication use. Arch Intern Med. 2010; 170:96-103.
6. Olfson M, Marcus SC, Druss BG. Effects of Food and Drug Administration warnings on antidepressant use in a national sample. Arch Gen Psychiat. 2008;65:94-101.
7. Wagner AK, Chan KA, Dashevsky I, et al. FDA drug prescribing warnings: is the black box half empty or half full? Pharmacoepidemiol Drug Saf. 2006;15:369-386. (Pubitemid 44018692)
8. Halpern MT, Khan ZM, Schmier JK, et al. Recommendations for evaluating compliance and persistence with hypertension therapy using retrospective data. Hypertension. 2006;47:1039-1048. (Pubitemid 44289157)
9. Schneeweiss S, Seeger JD, Maclure M, et al. Performance of comorbidity scores to control for confounding in epidemiologic studies using claims data. Am J Epidemiol. 2001;154:854-864. (Pubitemid 33000813)
10. Wagner AK, Soumerai SB, Zhang F, et al. Segmented regression analysis of interrupted time series studies in medication use research. J Clin Pharm Ther. 2002;27:299-309. (Pubitemid 34989269)
11. Pearson TA, Laurora I, Chu H, et al. The lipid treatment assessment project (L-TAP): a multicenter survey to evaluate the percentages of dyslipidemic patients receiving lipid-lowering therapy and achieving low-density lipoprotein cholesterol goals. Arch Intern Med. 2000; 160:459-467. (Pubitemid 30112269)
12. Parikh S, Shrank WH, Mogun H, et al. Statin utilization in nursing home patients after cardiac hospitalization. J Gen InternMed. 2010;25:1293-1299.
13. Kulik A, Levin R, Ruel M, et al. Patterns and predictors of statin use after coronary artery bypass graft surgery. J Thorac Cardiovasc Surg. 2007;134:932-938. (Pubitemid 47445596)
14. Thavendiranathan P, Bagai A, Brookhart MA, et al. Primary prevention of cardiovascular diseases with statin therapy: a meta-analysis of randomized controlled trials. Arch Intern Med. 2006;166:2307-2313. (Pubitemid 44833354)
15. Hoerger TJ, Bala MV, Bray JW, et al. Treatment patterns and distribution of low-density lipoprotein cholesterol levels in treatmenteligible United States adults. Am J Cardiol. 1998;82:61-65. (Pubitemid 28322036)
16. Kastelein JP, Akdim F, Stroes ES, et al. Simvastatin with or without ezetimibe in familial hypercholesterolemia. N Engl J Med. 2008;358: 1431-1443. (Pubitemid 351482735)
17. Drazen JM, Jarcho JA, Morrissey S, et al. Cholesterol lowering and ezetimibe. N Engl J Med. 2008;358:1507-1508. (Pubitemid 351482747)
18. Brown BG, Taylor AJ. Does ENHANCE diminish confidence in lowering LDL or in ezetimibe? N Engl J Med. 2008;358:1504-1507. (Pubitemid 351482746)
19. Berenson Alex. Journal warns cholesterol drugs vytorin and zetia may not work. New York Times, March 31, 2008. http://www.nytimes.com/2008/03/30/ business/30cnd-vytorin.html. Accessed April 4, 2012.