Propylthiouracyl-Related Liver Toxicity; Public Workshop; April 18, 2009, Washington, D.C.

The Food and Drug Administration (FDA) is announcing a 1-day public workshop, cosponsored with the American Thyroid Association (ATA), entitled “Propylthiouracyl-Related Liver Toxicity.”  This public workshop is intended to provide a public forum for discussion of the clinical, scientific, and regulatory issues pertaining to Propylthiouracyl-induced hepatitis to seek constructive input from academia, regulatory scientists, and other interested parties on the topic of Propylthiouracyl-induced hepatitis.

• Agenda [PDF]
• Federal Register Notice
• Propylthiouracil-related liver injury Healthcare Professionals Sheet (June 4, 2009)
• Meeting Transcript [PDF]

Presentations [PDFs]

• • Maternal Hyperthyroidism:Impact on the pregnancy and the fetus - Susan J. Mandel, University of Pennsylvania School of Medicine
  • Antithyroid Drugs: Pharmacology, Clinical Use and Adverse Events in Adults -
    David S. Cooper, MD, Johns Hopkins University
  • Hyperthyroidism during pregnancy:Balancing benefits and risks - Donald R Mattison, C. Alex Carrasquer and Albert Cunningham, NICHD and University of Louisville
  • Drug-Induced Liver Injury: Mechanisms and Detection - John R. Senior, M.D.
    Associate Director for Science, Office of Surveillance and Epidemiology (OSE), CDER
  • Serious Liver Injury Associated with Propylthiouracil and Methimazole: A Review of Postmarketing Cases from the Adverse Event Reporting System - Joslyn Swann, PharmD, MGA, BS RPh, Safety Evaluator, Division of Pharmacovigilance I, Office of Surveillance and Epidemiology, CDER
  • The Role of Propylthiouracil in the Management of Graves’ Disease in Adults:
    Frequency of PTU and Methimazole Use – Outpatient Prescription Utilization Data - Laura Governale, Pharm.D., MBA, Drug Utilization Data Analysis Team Leader, Division of Epidemiology, Office of Surveillance and Epidemiology, CDER
  • Drug-Induced Liver Injury: Epidemiology & Considerations of Risk - Mark Avigan, MD, CM, Director, Division of Pharmacovigilance I, Office of Surveillance & Epidemiology, CDER
  • Aplasia Cutis, Methimazole Embryopathy, and Possible Mechanisms of Teratogenesis - Miyun Tsai-Turton PhD, MPH, Division of Metabolism and Endocrinology Products, Office of Drug Evaluation II, CDER
  • Antithyroid Drugs: Approval History and Labeling - Naomi Lowy, M.D., Division of Metabolism and Endocrinology Products, Office of Drug Evaluation II, CDER

Date: April 18, 2009
Time: 8:00 a.m. - 3:30 p.m.
Location: The public workshop will be held at the Madison Hotel at 1177 15th St. N.W., Washington, D.C., 20005.

For map and directions visit: (http://www.loewshotels.com/en/Hotels/Washington-DC-Hotel/LocationInfo/Directions.aspx)

For meeting information, contact: Jeff O'Neill, telephone: (301) 796-0777 and fax: (301) 847-8753, email: jeff.o'neill@fda.hhs.gov