Document ID: FDA-2009-N-0167-0001
Agency: fda
Document Type: Notice
Title: Propylthiouracyl (PTU)-Related Liver Toxicity; Public Workshop
Posted Date: 2009-04-08T04:00Z

[Federal Register: April 8, 2009 (Volume 74, Number 66)]
[Notices]               
[Page 15993-15994]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08ap09-77]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration.

[Docket No. FDA-2009-N-0167]

 
Propylthiouracyl (PTU)-Related Liver Toxicity; Public Workshop

AGENCY:  Food and Drug Administration, HHS.

[[Page 15994]]

ACTION:  Notice of public workshop; request for comments.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing a 1-day 
public workshop, cosponsored with the American Thyroid Association 
(ATA), entitled ``Propylthiouracyl (PTU)-Related Liver Toxicity.'' This 
public workshop is intended to provide a public forum for discussion of 
the clinical, scientific, and regulatory issues pertaining to PTU-
induced hepatitis to seek constructive input from academia, regulatory 
scientists, and other interested parties on the topic of PTU-induced 
hepatitis. The input from this public workshop will help the ATA to 
develop guidelines for the management of hyperthyroidism and help 
inform FDA about necessary changes to prescription drug labeling for 
PTU.

DATES:  This public workshop will be held on Saturday, April 18, 2009, 
from 8 a.m. to 3:30 p.m. However, depending on the level of public 
participation, the meeting may be extended or may end early. Written or 
electronic comments will be accepted after the workshop until June 19, 
2009.

ADDRESSES:  The public workshop will be held at the Madison Hotel at 
1177 15th St., NW., Washington, DC 20005, 202-862-1600. We are opening 
a docket to receive your written or electronic comments. Written or 
electronic comments must be submitted to the docket by June 19, 2009.
    Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to: http://
www.regulations.gov.
    Comments should be identified with the docket number found in 
brackets in the heading of this document.
    Transcripts of the workshop will be available for review at the 
Division of Dockets Management and on the Internet at http://
www.regulations.gov approximately 45 days after the workshop.

FOR FURTHER INFORMATION CONTACT:  Jeff O'Neill, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6167, Silver Spring, MD 20903, 301-796-
0777, FAX: 301-847-8753, e-mail: jeff.o'neill@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    PTU-related liver toxicity has been reported in the published 
literature, and while direct comparative studies to another approved 
anti-thyroid medication, methimazole, are lacking, case series and 
postmarketing adverse event reports suggest a greater risk associated 
with PTU than methimazole. From prescription usage data, it appears 
that PTU is used less frequently than methimazole with perhaps a 
preferential use during pregnancy because of concerns about a rare 
congenital defect described in case reports of methimazole use. 
However, some data question whether an advantage of PTU use over 
methimazole exists, even during pregnancy.
    FDA and ATA are sponsoring this open public discussion involving 
academia, regulatory scientists, and other interested parties on the 
topic of PTU-induced hepatitis, because it is important to the health 
of patients with thyroid disease that the applicable scientific, 
clinical, and regulatory issues are raised and fully elucidated, and, 
to the greatest extent possible, consensus is reached.
    The ATA serves clinicians, scientists, and patients to facilitate 
open interchange and dissemination of scientific knowledge. The 
workshop is intended to provide a forum for discussion of the clinical, 
scientific, and regulatory issues pertaining to PTU-induced hepatitis.

II. Registration

    There is no fee to attend the workshop, and attendees do not need 
to register. Seating will be on a first-come, first-served basis. If 
you need special accommodations because of disability, please contact 
Jeff O'Neill (see FOR FURTHER INFORMATION CONTACT) at least 7 days 
before the workshop.

    Dated: April 2, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-7993 Filed 4-7-09; 8:45 am]

BILLING CODE 4160-01-S