OWH eUpdate 

www.fda.gov/womens Spring 2007 

In This Issue Message from the Director • OWH Research 

OWH is continuing to find innovative methods to promote women’s 

health through research and outreach. Last month, OWH announced 

the availability of our new medicine booklets that provide consumers 

with easy-to-read information on all FDA-approved products for HIV, 

elevated cholesterol, smoking cessation, hypertension, depression, 

and menopause. With the release of this update, OWH is pleased to 

announce another milestone - the availability of our newly revised 

Pregnancy Exposure Registry website. It is imperative that women 

have access to reliable information on the effects of medication use 

during pregnancy. Increasing numbers of reproductive age women 

are living with chronic diseases such as asthma, depression, HIV, 

epilepsy, and Multiple Sclerosis. At the same time, more drug 

manufacturers are being required to track the use of their products 

by pregnant women and subsequent pregnancy outcomes. Our 

registry website has been updated to provide comprehensive listings 

of exposure registries for a variety of drugs and vaccines. Please 

check out the article below on the new website as well as the other 

updates on OWH and FDA initiatives. 

• Outreach Initiatives 

• Hot Topics 

• Update Extras 

OWH Highlights 

Pregnancy Registry

Medicine Booklets 

Spanish Fact Sheets 

Sex and Gender Course

e-Update Archive

FDA Highlights 

Patient Info Gateway 

Links to info on cancer, HIV, 

and clinical trials 

Breast Pump Website Kathleen Uhl, MD 

Breast pump basics & more 

Assistant Commissioner for Women’s Health Safety Information

Recalls, withdrawals, and 

safety alerts OWH Research 

Maturity Health Matters 

Current issue focuses on 

cancers affecting women New Pregnancy Exposure Registry Website 

Upcoming Meetings The FDA Office of Women's Health has recently updated its web 

listing of pregnancy exposure registries. Pregnancy exposure 

registries are prospective observational studies that collect 

information on women who take medication during pregnancy. 

These studies provide important information on the effects of drug 

exposure on fetal development. 

FDA Advisory Committee 

Meetings 

Contact Us 

5600 Fishers Lane 

Room 16-65 

The OWH pregnancy exposure registry website provides links to 32 

registries for specific medical products and medical conditions 

including HIV/AIDS, epilepsy, and cancer. The website also lists all 

the drugs or vaccines used in a specific disease registry. 

Rockville, MD 20857 

301-827-0350 (phone) 

301-827-0926 (fax)

owh@fda.gov
To access the list and learn more information about pregnancy 

exposure registries, please visit: 

http://www.fda.gov/womens/registries/default.htm

 

******************************** 

OWH-Funded Research Wins Award 

Dr. Iacovos Kyprianou won the Best Poster Award at the 2007 

International Society for Optical Engineering (SPIE) Medical Imaging 

Conference for his OWH-funded project to identify appropriate 

medical imaging methods to improve the diagnosis of coronary 

artery disease in women. Coronary vessels in females are typically 

shorter in length and smaller in diameter than those of males which 

makes the accurate detection of coronary artery disease in women a 

challenging task for physicians. Dr. Kyprianou’s research presents 

one of the first methods to segment automatically the coronary 

arteries of a female patient CT scan. Projects like this one help 

develop accurate, high resolution models of the male and female 

heart that will be subsequently used as phantoms for medical 

imaging system optimization. This project is an excellent illustration 

of the need to better understand sex differences in disease diagnosis 

and treatment. 

To learn more about this study, contact Iacovos Kyprianou, PhD – 

FDA Center of Devices and Radiological Health at: 

iacovos.kyprianou@fda.hhs.gov

Outreach Initiatives 

OWH Sponsors Outreach Meetings

The FDA Office of Women’s Health sponsored two women’s health 

information discussion groups on April 12—13, 2007. The meetings 

were hosted by the AARP at their national headquarters. The first 

meeting focused on Hispanic health issues while the second 

addressed issues impacting all women. The aim of the workshops 

was to provide participants with the opportunity to: 

• Dialogue and network with their peers about shared women’s 

health interests 

• Discuss ways to collaborate in current and future 

outreach activities with FDA and other groups 

• Learn about new FDA OWH consumer information that is 

available in English, Spanish and additional languages 

• Link with the FDA field staff who can assist with consumer 

health projects 

About 50 representatives from national organizations 

representing women's advocacy, health professionals, hospitals, 
major corporations, employee assistance programs, military 

medicine, migrant health, minority groups, and disease groups 

attended the meetings. 

During the round table discussions, several issues emerged as key 

health concerns including medication safety, HPV, smoking, mental 

health, CVD, clinical trials, diabetes, and HIV. The meetings 

produced tremendous interest in collaborating with FDA/OWH on 

consumer health information projects throughout the year. 

******************************** 

Celebrate National Women’s Health Week 

National Women’s Health Week is scheduled for May 13-19, 2007. 

This year’s theme is "It's Your Time: Pamper Your Mind, Body and 

Spirit." The week is designed to highlight women’s health issues and 

promote healthy lifestyles for women. The week also includes a 

celebration of Women’s Check-up Day on May 14th to promote health 

screenings. 

OWH would like to encourage groups and individuals to order any of 

the free OWH fact sheets and brochures for use during women’s 

health week activities. 

To order OWH publications, go to: 

http://www.pueblo.gsa.gov/rc/f06owhcard.htm

To download OWH publications, go to: 

http://www.fda.gov/womens/getthefacts/default.htm

To visit the National Women’s Health Week website, go to: 

http://www.4woman.gov/whw/

Hot Topics 

Zelnorm Discontinued in the U.S. 

On March 30, 2007, FDA announced that the marketing of Zelnorm 

(tegaserod) has been voluntarily suspended in the United States due 

to an increased risk of serious cardiovascular adverse events (heart 

problems) associated with use of the drug. 

Zelnorm is a prescription medicine approved in July 2002 for shortterm treatment of women with irritable bowel syndrome whose 

primary symptom is constipation. It was subsequently approved in 

August 2004 for treatment of chronic constipation for men and 

women under age 65. 
FDA is currently advising patients who are using Zelnorm to contact 

their health care providers to discuss treatment alternatives. 

Patients who are taking Zelnorm should seek emergency medical 

care if they experience severe chest pain, shortness of breath, 

dizziness, sudden onset of weakness or difficulty walking or talking, 

or other symptoms of a heart attack or stroke. 

To view the FDA Public Health Advisory on Zelnorm, visit: 

http://www.fda.gov/cder/drug/advisory/tegaserod.htm

*************************** 

Tykerb Approved for Advanced Breast Cancer 

On March 13, 2007, the FDA approved Tykerb (lapatinib) as a new 

targeted anti-cancer treatment. Tykerb is to be used in combination 

with capectabine (Xeloda), another cancer drug, for patients with 

advanced, metastatic breast cancer that is HER2 positive (tumors 

that exhibit HER2 protein). The combination treatment is indicated 

for women who have received prior therapy with other cancer drugs. 

Tykerb is a kinase inhibitor that works through multiple pathways 

(targets) to deprive tumor cells of signals needed to grow. 

To view the FDA Press Release, visit: 

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01586.html

For more information on Breast Cancer, visit: 

The National Cancer Institute 

http://www.cancer.gov/cancertopics/types/breast

*************************** 

Medwatch

FDA's MedWatch program is a reporting system that allows 

healthcare professionals and consumers to let the agency know 

about serious problems that they believe are caused by FDA 

regulated products (prescription and over-the-counter drugs, 

biologics/vaccines, and medical devices). 

MedWatch reports can be submitted by phone at (800) FDA-1088, 

by fax at (800) FDA-0178, or on the MedWatch website. If the 

report involves a serious adverse event with a vaccine, call 1-800-

822-7967. 

Consumers can either work with their health care provider to report 

a problem or they can complete the online reporting form on the 

MedWatch website. 
Update Extras 

Conferences 

The OWH Outreach Team is busy exhibiting at conferences across 

the country to increase awareness and dissemination of the over 50 

OWH health education fact sheets and brochures available for 

consumers. 

Visit the OWH exhibit booth at these upcoming conferences: 

National Osteoporosis Foundation, April 18 -22 – Washington, DC 

CDC Diabetes and Obesity Conference, April 30 –May 3 – Atlanta, GA 

Organization for the Study of Sex Differences, May 9 -12 – Washington, DC 

Tavis Smiley Road to Health Expo, May 11 -12 – Oakland, CA 

National Rural Health Association, May 14 -18 – Anchorage, AK 

American Academy of Physician Assistants, May 29 - 30 – Philadelphia, PA 

American College Health Association, May 30 – June 2 – San Antonio, TX 

National Mental Health Association, June 7 -9 – Washington, DC 

American Diabetes Association, June 22 -26 – Chicago, IL 

****************************** 

Other Events and Presentations 

DIA Issues in Gender Hormone Therapy Meeting

Chairperson: Kathleen Uhl 

Date: May 9, 2007 

Location: Washington Marriott Hotel, Washington, DC 

Website: Drug Information Association

FDA Public Hearing 

Topic: Use of Medication Guides to Distribute Drug 

 Risk Information to Patients 

Dates: June 12-13, 2007 

Time: 8:30 a.m. – 4:30 p.m. 

Location: National Transportation and Safety Board Conference 

 Center – 429 L’Enfant Plaza SW, Washington, DC 

Website: 

http://www.fda.gov/cder/meeting/medication_guides_200706.htm

2007 Minority Women’s Health Summit 

Date: August 23-26, 2007 

Location: Hyatt Regency on Capitol Hill, Washington, DC 

Website: HHS Office of Women’s Health
Presentations 

Conference: Organization for the Study of Sex Differences 

Poster Title: Standardization of Clinical Trial Data Submitted to the 

 FDA: Is it Valuable to Track the Inclusion of Women in 

 Clinical Trials? 

Authors: Ellen Pinnow1, Armando Oliva2, Jonathan Levine2, 

 Ameeta Parekh1, Kathleen Uhl1, 1OWH and 2Office of 

 Critical Path Programs, FDA

Dates: May 11, 2007 

Location: Washington Plaza Hotel, Washington, DC 

Conference: Organization for the Study of Sex Differences 

Poster Title: Sex Differences of Inclusion Criteria in Clinical Trials: A 

 Regulatory Review of Contraception Requirements

Authors: Ellen Pinnow1, Pamela Scott1, Janelle Derbis2, Theresa 

 Toigo2, Kathleen Uhl1, 1OWH and 2Office of Special 

 Health Issues (OSHI), FDA

Dates: May 11, 2007 

Location: Washington Plaza Hotel, Washington, DC 

Conference: Home Healthcare Technology: Promoting the Safe 

 Migration of Medical Devices into the Home

Panel: Talk with the Government 

Authors: Ellen Pinnow

Dates: May 22, 2007 

Location: Houston, TX

Conference: AcademyHealth Annual Research Meeting 

Poster Title: Drug or Biologic Exposure During Pregnancy: An Update on 

 Pregnancy Exposure Registries 

Authors: Pellavi Sharma1, Ameeta Parekh1, Elizabeth Duvall-Miller2, 

 Connie O’Leary2, Kathleen Uhl1 (1OWH) 

Dates: June 03, 2007 

Location: Orlando Florida 

 

Conference: 15th Annual Congress on Women’s Health 

Poster Title: Updates to the FDA Office of Women’s Health Pregnancy 

 Exposure Registries Listing 

Authors: Pellavi Sharma, Ellen Pinnow, Ameeta Parekh, 

 Elizabeth Duvall- Miller, Connie O’Leary, Kathleen Uhl 

Dates: June 3-5, 2007 

Location: Hilton Head, SC 

Conference: Organization of Teratology Information Specialists 

 (OTIS) 

Poster Title: A Revamped Tool for Pregnant Women: Updates to the 

 FDA Office of Women’s Health Pregnancy Exposure 

 Registries Listing 

Authors: Pellavi Sharma1, Ameeta Parekh1, Elizabeth Duvall-Miller2, 

 Connie O’Leary2, Kathleen Uhl1 (1OWH) 

Dates: June 25, 2007 

Location: Pittsburgh, PA