D J Graham

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. ncbi 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
  2. ncbi 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
  3. ncbi 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
  4. ncbi 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
  5. ncbi 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
  6. ncbi 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
  7. ncbi 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
  8. ncbi 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
  9. ncbi 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
  10. ncbi 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

Detail Information

Publications20

  1. ncbi 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...
  2. ncbi 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
    ....
  3. ncbi 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...
  4. ncbi 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...
  5. ncbi 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
    ..3, 1385). CONCLUSIONS: Troglitazone use was associated with a marked increase in risk of hospitalized acute idiopathic liver injury and ALF...
  6. ncbi 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...
  7. ncbi 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...
  8. ncbi 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...
  9. ncbi 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
    ....
  10. ncbi 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...
  11. ncbi 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
    ..CONCLUSIONS: Compliance with product labeling was low for both recommendations. Understanding the reasons for this finding could help improve risk management strategies...
  12. ncbi 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
    ..CONCLUSIONS: Healthcare practitioners should be aware that a prolonged QTc interval is a potential indicator of cardiovascular risk, and should exercise caution in prescribing potentially QT-prolonging medications to certain patients...
  13. ncbi Risk of unexplained acute liver failure in diabetes mellitus
    David J Graham
    Arch Intern Med 163:2649-50; author reply 2650-1. 2003
  14. ncbi COX-2 inhibitors, other NSAIDs, and cardiovascular risk: the seduction of common sense
    David J Graham
    JAMA 296:1653-6. 2006
  15. ncbi 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
  16. ncbi 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
    ....
  17. ncbi 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 Telithromycin and acute liver failure
    David J Graham
    N Engl J Med 355:2260-1. 2006
  19. ncbi 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 Pneumonitis with antiandrogens
    Syed Rizwanuddin Ahmad
    Ann Intern Med 139:528-9; author reply 529. 2003