D J Graham
Affiliation: Food and Drug Administration
- Validation of a computer case definition for sudden cardiac death in opioid usersVivian 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...
- Liver enzyme monitoring in patients treated with troglitazoneD 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...
- 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 studyDavid J Graham
Office of Drug Safety, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD, USA
Lancet 365:475-81. 2005....
- Incidence of hospitalized rhabdomyolysis in patients treated with lipid-lowering drugsDavid 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...
- Troglitazone-induced liver failure: a case studyDavid 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...
- Incidence of idiopathic acute liver failure and hospitalized liver injury in patients treated with troglitazoneDavid 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...
- The risk for outpatient antibiotic-treated infections following a course of oral corticosteroids among children with asthmaH 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...
- Peripheral neuropathy in patients treated with leflunomideRenan 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...
- Risk of acute myocardial infarction, stroke, heart failure, and death in elderly Medicare patients treated with rosiglitazone or pioglitazoneDavid 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...
- Onset of acute myocardial infarction after use of non-steroidal anti-inflammatory drugsTarek A Hammad
Office of Surveillance and Epidemiology, Food and Drug Administration, Silver Spring, MD 20993 0002, USA
Pharmacoepidemiol Drug Saf 17:315-21. 2008....
- The role of databases in drug postmarketing surveillanceE 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...
- 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...
- Risk factors for prolonged QTc among US adults: Third National Health and Nutrition Examination SurveyStephen 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...
- COX-2 inhibitors, other NSAIDs, and cardiovascular risk: the seduction of common senseDavid J Graham
JAMA 296:1653-6. 2006
- Factors associated with celecoxib and rofecoxib utilizationNigel 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...
- COX-2 selective non-steroidal anti-inflammatory drugs and cardiovascular diseaseWayne A Ray
Vanderbilt University School of Medicine, A 1124, MCN, Nashville, TN 37232, USA
Pharmacoepidemiol Drug Saf 12:67-70. 2003
- High frequency of use of rofecoxib at greater than recommended doses: cause for concernMarie 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...
- Risk of unexplained acute liver failure in diabetes mellitusDavid J Graham
Arch Intern Med 163:2649-50; author reply 2650-1. 2003
- Health plan administrative databases can efficiently identify serious myopathy and rhabdomyolysisSusan 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....
- Telithromycin and acute liver failureDavid J Graham
N Engl J Med 355:2260-1. 2006
- Pneumonitis with antiandrogensSyed Rizwanuddin Ahmad
Ann Intern Med 139:528-9; author reply 529. 2003