Documented tuberculin skin testing among infliximab users following a multi‐modal risk communication interventions

Following its licensure, tuberculosis (TB) was reported as a potential adverse effect of infliximab. Subsequently, the product circular was changed to recommend tuberculin skin testing before patients received infliximab, which was reinforced by several risk communication efforts. The aim of this study was to evaluate patterns and predictors of documented tuberculin skin testing in patients before and after manufacturer, federal, and academic risk communications.

[1]  A. Stergachis,et al.  Impact of mailed warning to prescribers on the co‐prescription of tramadol and antidepressants , 2005, Pharmacoepidemiology and drug safety.

[2]  W. Mow,et al.  High incidence of anergy in inflammatory bowel disease patients limits the usefulness of PPD screening before infliximab therapy. , 2004, Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association.

[3]  Zili Li,et al.  What is prescription labeling communicating to doctors about hepatotoxic drugs? A study of FDA approved product labeling , 2004, Pharmacoepidemiology and drug safety.

[4]  J. Woodcock.  Risk management: issues for outcomes research. , 2003, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[5]  P. Seligman.  ‘Dear doctor…’—Evaluating the impact of risk communication efforts , 2003, Pharmacoepidemiology and drug safety.

[6]  D. Graham,et al.  A study of compliance with FDA recommendations for pemoline (Cylert). , 2002, Journal of the American Academy of Child and Adolescent Psychiatry.

[7]  S. Riminton,et al.  Tuberculosis and treatment with infliximab. , 2002, The New England journal of medicine.

[8]  Joseph Keane,et al.  Tuberculosis associated with infliximab, a tumor necrosis factor alpha-neutralizing agent , 2001 .

[9]  D J Graham,et al.  Liver enzyme monitoring in patients treated with troglitazone. , 2001, JAMA.

[10]  P. Honig,et al.  Risk management of marketed drugs: FDA and the interface with the practice of medicine , 2001, Pharmacoepidemiology and drug safety.

[11]  Michael J. Goodman,et al.  Contraindicated use of cisapride: impact of food and drug administration regulatory action. , 2000, JAMA.

[12]  R N Maini,et al.  Infliximab and methotrexate in the treatment of rheumatoid arthritis. Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group. , 2000, The New England journal of medicine.

[13]  D. Graham.  Bisphosphonate gastrointestinal damage: perspective and research needs , 2000, Pharmacoepidemiology and drug safety.

[14]  P. Lipsky,et al.  Infliximab (chimeric anti-tumour necrosis factor α monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial , 1999, The Lancet.

[15]  M. Cabana,et al.  Why don't physicians follow clinical practice guidelines? A framework for improvement. , 1999, JAMA.

[16]  P. Rutgeerts,et al.  Infliximab for the treatment of fistulas in patients with Crohn's disease. , 1999, The New England journal of medicine.

[17]  S. Targan,et al.  A Short-Term Study of Chimeric Monoclonal Antibody cA2 to Tumor Necrosis Factor α for Crohn's Disease , 1997 .

[18]  L. Melton,et al.  Epidemiologic aspects of Crohn's disease: a population based study in Olmsted County, Minnesota, 1943-1982. , 1988, Gut.

[19]  B. Cronstein,et al.  Adenosine A2A or A3 receptors are required for inhibition of inflammation by methotrexate and its analog MX-68. , 2003, Arthritis and rheumatism.