04-9736. National Toxicology Program (NTP); National Institute of Environmental Health Sciences; The NTP Center for the Evaluation of Risks to Human Reproduction (CERHR) Expert Panel Report on the Developmental and Reproductive Toxicity of ...

SUMMARY:

Notice is hereby given of the availability on April 19, 2004, of the Expert Panel Report on the Developmental and Reproductive Toxicity of Fluoxetine. This report includes the summaries and conclusions of the expert panel's evaluation of the scientific data for potential reproductive and/or developmental hazards associated with exposure to fluoxetine. The CERHR held this expert panel meeting March 3-5, 2004. CERHR is seeking public comment on this report and additional information about recent, relevant toxicology or human exposure studies.

Availability of Reports

This expert panel report will be available by April 19, 2004 on the CERHR Web site (http://cerhr.niehs.nih.gov) and in printed copy or compact disc by contacting the CERHR [P.O. Box 12233, MD EC-32, Research Triangle Park, NC 27709; telephone: [phone]; fax: [phone]; or e-mail: [e-mail]].

Request for Public Comments

The CERHR invites public comments on this expert panel report and input regarding any recent, relevant toxicology or human exposure studies. The CERHR requests that all comments and other information be submitted to the CERHR at the address above by June 17, 2004.

All public comments received by the date above will be reviewed and included in the final NTP-CERHR monograph on fluoxetine to be prepared by NTP staff. The NTP-CERHR monograph will include the NTP brief, expert panel report, and all public comments received on the report. The brief will provide the NTP's interpretation of the potential for adverse reproductive and/or developmental effects to humans from exposure to fluoxetine. The NTP-CERHR monograph will be sent to appropriate federal agencies and will be available to the public and the scientific community on the CERHR web site, in hardcopy, or on compact disk.

Background

Fluoxetine hydrochloride (Prozac®; Sarafem^TM), an antidepressant, is a widely prescribed drug in the United States. The CERHR selected fluoxetine for evaluation because of (1) sufficient reproductive and developmental studies, (2) sufficient human exposure information, (3) changing prescription patterns, and (4) public concern about potential reproductive and/or developmental hazards associated with exposure. Fluoxetine hydrochloride, under the name Sarafem^TM), is prescribed to treat premenstrual dysphoric disorder (PMDD), potentially increasing the number of exposures for women of childbearing age. Furthermore, the Food and Drug Administration recently approved Prozac®; for use in 7-17 year-olds thereby increasing exposures of children.

A 12-member expert panel composed of scientists from the federal government, universities, and private companies conducted an evaluation of the reproductive and developmental toxicities of fluoxetine hydrochloride (Federal Register Vol. 68, No. 216, pages 63122—63123, November 2003). Public deliberations by the panel took place March 3-5, 2004, at the Holiday Inn Old Town Select in Alexandria, Virginia. Following the March meeting, the draft expert panel report was revised to incorporate the panel's conclusions and subsequently reviewed by Fluoxetine Expert Panel, NTP scientists, and CERHR personnel.

Additional Information About CERHR

The NTP and the NIEHS established the NTP CERHR in June 1998 (Federal Register Vol. 63, No. 239, page 68782, December 1998). The purpose of the CERHR is to provide scientifically based, uniform assessments of the potential for adverse effects on reproduction and development caused by agents to which humans may be exposed. Further information on the CERHR's chemical review process, including how to nominate chemicals for evaluation and scientists for the expert registry, can be obtained from its Web site (http://cerhr.niehs.nih.gov) or by contacting the CERHR directly (see address above). The CERHR also serves as a resource for information on various environmental exposures and their potential to affect pregnancy and child development. The web site has information about common concerns related to fertility, pregnancy and the health of unborn children and links to other resources for information about public health.

Dated: April 21, 2004.

Samuel H. Wilson,

Deputy Director, National Institute of Environmental Health Sciences.