David J Graham

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. doi request reprint Risk of acute myocardial infarction, stroke, heart failure, and death in elderly Medicare patients treated with rosiglitazone or pioglitazone
    David J Graham
    Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave, Bldg 22, Room 4314, Silver Spring, MD 20993 0002, USA
    JAMA 304:411-8. 2010
  2. doi request reprint Cardiovascular, bleeding, and mortality risks in elderly Medicare patients treated with dabigatran or warfarin for nonvalvular atrial fibrillation
    David J Graham
    From the Office of Surveillance and Epidemiology D J G, M E R, K M, M R G, M H, Office of Biostatistics R Z, M L, and Office of New Drugs M R S, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD Acumen LLC, Burlingame, CA M W, T S, T E M Department of Economics, Stanford University, Stanford, CA T E M and Centers for Medicare and Medicaid Services, Washington, DC C W, J A K
    Circulation 131:157-64. 2015
  3. doi request reprint Cardiovascular and mortality risks in Parkinson's disease patients treated with entacapone
    David J Graham
    Office of Epidemiology and Surveillance, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
    Mov Disord 28:490-7. 2013
  4. doi request reprint Stroke, Bleeding, and Mortality Risks in Elderly Medicare Beneficiaries Treated With Dabigatran or Rivaroxaban for Nonvalvular Atrial Fibrillation
    David J Graham
    Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland
    JAMA Intern Med 176:1662-1671. 2016
  5. doi request reprint Cardiovascular and mortality risks in older Medicare patients treated with varenicline or bupropion for smoking cessation: an observational cohort study
    David J Graham
    Office of Surveillance and Epidemiology, Food and Drug Administration, Silver Spring, MD, USA
    Pharmacoepidemiol Drug Saf 23:1205-12. 2014
  6. ncbi request reprint Troglitazone-induced liver failure: a case study
    David J Graham
    Office of Drug Safety, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, HFD 400, Room 15B 32, Rockville, MD 20857, USA
    Am J Med 114:299-306. 2003
  7. doi request reprint Onset of acute myocardial infarction after use of non-steroidal anti-inflammatory drugs
    Tarek A Hammad
    Office of Surveillance and Epidemiology, Food and Drug Administration, Silver Spring, MD 20993 0002, USA
    Pharmacoepidemiol Drug Saf 17:315-21. 2008
  8. doi request reprint Cardiovascular and mortality risk in elderly Medicare beneficiaries treated with olmesartan versus other angiotensin receptor blockers
    David J Graham
    Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA
    Pharmacoepidemiol Drug Saf 23:331-9. 2014
  9. ncbi request reprint Incidence of hospitalized rhabdomyolysis in patients treated with lipid-lowering drugs
    David J Graham
    Office of of Drug Safety, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD 20857, USA
    JAMA 292:2585-90. 2004
  10. doi request reprint Challenges in evaluating cancer as a clinical outcome in postapproval studies of drug safety
    Simone P Pinheiro
    Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Md Electronic address
    Ann Epidemiol 26:735-740. 2016

Collaborators

Detail Information

Publications20

  1. doi request reprint Risk of acute myocardial infarction, stroke, heart failure, and death in elderly Medicare patients treated with rosiglitazone or pioglitazone
    David J Graham
    Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave, Bldg 22, Room 4314, Silver Spring, MD 20993 0002, USA
    JAMA 304:411-8. 2010
    ..Studies have suggested that the use of rosiglitazone may be associated with an increased risk of serious cardiovascular events compared with other treatments for type 2 diabetes...
  2. doi request reprint Cardiovascular, bleeding, and mortality risks in elderly Medicare patients treated with dabigatran or warfarin for nonvalvular atrial fibrillation
    David J Graham
    From the Office of Surveillance and Epidemiology D J G, M E R, K M, M R G, M H, Office of Biostatistics R Z, M L, and Office of New Drugs M R S, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD Acumen LLC, Burlingame, CA M W, T S, T E M Department of Economics, Stanford University, Stanford, CA T E M and Centers for Medicare and Medicaid Services, Washington, DC C W, J A K
    Circulation 131:157-64. 2015
    ..The comparative safety of dabigatran versus warfarin for treatment of nonvalvular atrial fibrillation in general practice settings has not been established...
  3. doi request reprint Cardiovascular and mortality risks in Parkinson's disease patients treated with entacapone
    David J Graham
    Office of Epidemiology and Surveillance, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
    Mov Disord 28:490-7. 2013
    ..09; 95% CI, 0.98-4.45) or absence (HR, 0.51; 95% CI, 0.27-0.95) of advanced PD-related morbidities (P value for interaction=0.004). Entacapone was not associated with an increased risk of AMI, stroke, or death in elderly patients with PD...
  4. doi request reprint Stroke, Bleeding, and Mortality Risks in Elderly Medicare Beneficiaries Treated With Dabigatran or Rivaroxaban for Nonvalvular Atrial Fibrillation
    David J Graham
    Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland
    JAMA Intern Med 176:1662-1671. 2016
    ..There are no randomized head-to-head comparisons of these drugs for stroke, bleeding, or mortality outcomes...
  5. doi request reprint Cardiovascular and mortality risks in older Medicare patients treated with varenicline or bupropion for smoking cessation: an observational cohort study
    David J Graham
    Office of Surveillance and Epidemiology, Food and Drug Administration, Silver Spring, MD, USA
    Pharmacoepidemiol Drug Saf 23:1205-12. 2014
    ..To compare cardiovascular and mortality risks in elderly patients treated with varenicline or bupropion for smoking cessation...
  6. ncbi request reprint Troglitazone-induced liver failure: a case study
    David J Graham
    Office of Drug Safety, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, HFD 400, Room 15B 32, Rockville, MD 20857, USA
    Am J Med 114:299-306. 2003
    ..We evaluated the clinical features of all cases reported to the Food and Drug Administration and estimated the duration and magnitude of the risk of liver failure associated with continued use of the drug...
  7. doi request reprint Onset of acute myocardial infarction after use of non-steroidal anti-inflammatory drugs
    Tarek A Hammad
    Office of Surveillance and Epidemiology, Food and Drug Administration, Silver Spring, MD 20993 0002, USA
    Pharmacoepidemiol Drug Saf 17:315-21. 2008
    ....
  8. doi request reprint Cardiovascular and mortality risk in elderly Medicare beneficiaries treated with olmesartan versus other angiotensin receptor blockers
    David J Graham
    Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA
    Pharmacoepidemiol Drug Saf 23:331-9. 2014
    ....
  9. ncbi request reprint Incidence of hospitalized rhabdomyolysis in patients treated with lipid-lowering drugs
    David J Graham
    Office of of Drug Safety, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD 20857, USA
    JAMA 292:2585-90. 2004
    ..Lipid-lowering agents are widely prescribed in the United States. Reliable estimates of rhabdomyolysis risk with various lipid-lowering agents are not available...
  10. doi request reprint Challenges in evaluating cancer as a clinical outcome in postapproval studies of drug safety
    Simone P Pinheiro
    Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Md Electronic address
    Ann Epidemiol 26:735-740. 2016
    ..This commentary summarizes the most salient issues discussed at the meeting...
  11. doi request reprint Uptake of new drugs in the early post-approval period in the Mini-Sentinel distributed database
    Katrina Mott
    CDER Office of Surveillance and Epidemiology, U S Food and Drug Administration, Silver Spring, MD, USA
    Pharmacoepidemiol Drug Saf 25:1023-32. 2016
    ..This study characterized new drug uptake in the Mini-Sentinel Distributed Database and determined statistical power to detect levels of risk in post-launch safety assessments...
  12. doi request reprint Comparative Risk of Anaphylactic Reactions Associated With Intravenous Iron Products
    Cunlin Wang
    Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland
    JAMA 314:2062-8. 2015
    ..All intravenous (IV) iron products are associated with anaphylaxis, but the comparative safety of each product has not been well established...
  13. doi request reprint Use of an active surveillance system by the FDA to observe patterns of quinine sulfate use and adverse hematologic outcomes in CMS Medicare data
    Monika Houstoun
    Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA
    Pharmacoepidemiol Drug Saf 23:911-7. 2014
    ..We examined quinine use trends among Medicare beneficiaries focusing on indications for use and associations with adverse hematologic outcomes...
  14. doi request reprint Risk of acute myocardial infarction, stroke, or death in patients initiating olmesartan or other angiotensin receptor blockers - a cohort study using the Clinical Practice Research Datalink
    Esther H Zhou
    Office of Surveillance and Epidemiology, U S Food and Drug Administration, MD, USA
    Pharmacoepidemiol Drug Saf 23:340-7. 2014
    ..We evaluated the risks of acute myocardial infarction (AMI) and death in patients initiating Olm compared with an active comparator group, other angiotensin receptor blockers (ARBs), with a focus on high-dose and diabetic subgroups...
  15. ncbi request reprint Risk factors for prolonged QTc among US adults: Third National Health and Nutrition Examination Survey
    Stephen R Benoit
    Food and Drug Administration, Rockville, Maryland, USA
    Eur J Cardiovasc Prev Rehabil 12:363-8. 2005
    ..Although research exists on the relationship between QT prolongation and clinical outcome, few studies have described risk factors for prolonged QT interval in the general population...
  16. doi request reprint Association Between Changes in CMS Reimbursement Policy and Drug Labels for Erythrocyte-Stimulating Agents With Outcomes for Older Patients Undergoing Hemodialysis Covered by Fee-for-Service Medicare
    Cunlin Wang
    Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland
    JAMA Intern Med 176:1818-1825. 2016
    ..In response to concerns that these measures could have adverse effects on patient care and outcomes, the CMS and the FDA initiated a collaboration to assess the effect...
  17. doi request reprint Candidate metrics for evaluating the impact of prescriber education on the safe use of extended-release/long-acting (ER/LA) opioid analgesics
    Mary E Willy
    Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA
    Pain Med 15:1558-68. 2014
    ..The objective of this study was to develop metrics to assess opioid prescribing behavior as part of the evaluation of the Extended-Release/Long-Acting (ER/LA) Opioid Analgesic Risk Evaluation and Mitigation Strategies (REMS)...
  18. ncbi request reprint Incidence of idiopathic acute liver failure and hospitalized liver injury in patients treated with troglitazone
    David J Graham
    Office of Drug Safety, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857, USA
    Am J Gastroenterol 98:175-9. 2003
    ..This study was conducted to estimate the incidence rates of hospitalized idiopathic acute liver injury and ALF among troglitazone-treated patients...
  19. ncbi request reprint Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: nested case-control study
    David J Graham
    Office of Drug Safety, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD, USA
    Lancet 365:475-81. 2005
    ....
  20. ncbi request reprint Peripheral neuropathy in patients treated with leflunomide
    Renan A Bonnel
    Office of Drug Safety, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, MD 20857, USA
    Clin Pharmacol Ther 75:580-5. 2004
    ..Our objective was to describe the clinical features, time course, and outcome of new-onset peripheral neuropathy occurring in patients treated with leflunomide...