D J Graham

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. pmc Validation of a computer case definition for sudden cardiac death in opioid users
    Vivian K Kawai
    Division of Pharmacoepidemiology, Department of Preventive Medicine, Nashville, TN, USA
    BMC Res Notes 5:473. 2012
  2. ncbi request reprint Liver enzyme monitoring in patients treated with troglitazone
    D J Graham
    Office of Postmarketing Drug Risk Assessment, US Food and Drug Administration, 5600 Fishers Ln, HFD 400, Room 15B 32, Rockville, MD 20857, USA
    JAMA 286:831-3. 2001
  3. 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
  4. 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
  5. 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
  6. 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
  7. ncbi request reprint The risk for outpatient antibiotic-treated infections following a course of oral corticosteroids among children with asthma
    H Davis
    Office of Epidemiology and Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857, USA
    J Asthma 35:419-25. 1998
  8. 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
  9. 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
  10. 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

Detail Information

Publications21

  1. pmc Validation of a computer case definition for sudden cardiac death in opioid users
    Vivian K Kawai
    Division of Pharmacoepidemiology, Department of Preventive Medicine, Nashville, TN, USA
    BMC Res Notes 5:473. 2012
    ..However, the definition has not been specifically validated for prescription opioid users, for whom out-of-hospital overdose deaths may be difficult to distinguish from sudden cardiac death...
  2. ncbi request reprint Liver enzyme monitoring in patients treated with troglitazone
    D J Graham
    Office of Postmarketing Drug Risk Assessment, US Food and Drug Administration, 5600 Fishers Ln, HFD 400, Room 15B 32, Rockville, MD 20857, USA
    JAMA 286:831-3. 2001
    ..Soon after initial marketing in March 1997, troglitazone, the first thiazolidinedione antidiabetic agent, was found to cause life-threatening acute liver failure. The drug was removed from the market in March 2000...
  3. 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
    ....
  4. 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...
  5. 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...
  6. 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...
  7. ncbi request reprint The risk for outpatient antibiotic-treated infections following a course of oral corticosteroids among children with asthma
    H Davis
    Office of Epidemiology and Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857, USA
    J Asthma 35:419-25. 1998
    ..65 (95% CI 0.53-0.97). We conclude that one course of oral corticosteroids does not increase asthmatic children's risk for infections treated with outpatient antibiotics...
  8. 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...
  9. 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...
  10. 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
    ....
  11. ncbi request reprint The role of databases in drug postmarketing surveillance
    E M Rodriguez
    Division of Drug Risk Evaluation II, Office of Postmarketing Drug Risk Assessment, Center for Drug Evaluation and Research, FDA, 5600 Fishers Lane, HFD 440, Rockville, MD 20857, USA
    Pharmacoepidemiol Drug Saf 10:407-10. 2001
    ..Finally, we discuss the FDA's use of the databases it accesses through its Cooperative Agreement Program to conduct high priority studies to support regulatory decision-making...
  12. ncbi request reprint A study of compliance with FDA recommendations for pemoline (Cylert)
    Mary E Willy
    Office of Drug Safety, Food and Drug Administration, Rockville, MD 20857, USA
    J Am Acad Child Adolesc Psychiatry 41:785-90. 2002
    ..To assess compliance with product labeling recommendations to use pemoline as second-line therapy for attention-deficit/hyperactivity disorder (ADHD) and to obtain baseline and biweekly liver enzyme tests...
  13. 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...
  14. ncbi request reprint COX-2 inhibitors, other NSAIDs, and cardiovascular risk: the seduction of common sense
    David J Graham
    JAMA 296:1653-6. 2006
  15. ncbi request reprint Factors associated with celecoxib and rofecoxib utilization
    Nigel S B Rawson
    Center for Health Care Policy and Evaluation, Eden Prairie, MN Oakville, ON, Canada
    Ann Pharmacother 39:597-602. 2005
    ..However, adverse reaction data suggest that the use of COX-2 selective NSAIDs is associated with clinically significant GI events...
  16. ncbi request reprint COX-2 selective non-steroidal anti-inflammatory drugs and cardiovascular disease
    Wayne A Ray
    Vanderbilt University School of Medicine, A 1124, MCN, Nashville, TN 37232, USA
    Pharmacoepidemiol Drug Saf 12:67-70. 2003
  17. ncbi request reprint High frequency of use of rofecoxib at greater than recommended doses: cause for concern
    Marie R Griffin
    Department of Preventive Medicine, Vanderbilt University Medical Center, Nashville, TN 37232, USA
    Pharmacoepidemiol Drug Saf 13:339-43. 2004
    ..Thus chronic use of high doses of rofecoxib has implications for patient safety...
  18. ncbi request reprint Risk of unexplained acute liver failure in diabetes mellitus
    David J Graham
    Arch Intern Med 163:2649-50; author reply 2650-1. 2003
  19. ncbi request reprint Health plan administrative databases can efficiently identify serious myopathy and rhabdomyolysis
    Susan E Andrade
    Meyers Primary Care Institute Fallon Foundation and University of Massachusetts Medical School, 630 Plantation Street, Worcester, MA 01605, USA
    J Clin Epidemiol 58:171-4. 2005
    ....
  20. ncbi request reprint Telithromycin and acute liver failure
    David J Graham
    N Engl J Med 355:2260-1. 2006
  21. ncbi request reprint Pneumonitis with antiandrogens
    Syed Rizwanuddin Ahmad
    Ann Intern Med 139:528-9; author reply 529. 2003