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Notice

Propylthiouracyl (PTU)-Related Liver Toxicity; Public Workshop

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Information about this document as published in the Federal Register.

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AGENCY:

Food and Drug Administration, HHS.

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ACTION:

Notice of public workshop; request for comments.

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.

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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.

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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.

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Dated: April 2, 2009.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.

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[FR Doc. E9-7993 Filed 4-7-09; 8:45 am]

BILLING CODE 4160-01-S