OWH eUpdate 

www.fda.gov/womens Summer 2007 

In This Issue Message from the Director • OWH Research 

OWH continues to seek innovative scientific and outreach 

opportunities to promote and advance the health of women 

nationwide. On the research front, OWH recently selected the 

recipients of the FY07 intramural funding awards. OWH is also 

embarking on a new partnership with the Agency for Healthcare 

Research and Quality (AHRQ) and the FDA Center for Devices and 

Radiological Health (CDRH) to study the long term health outcomes 

in patients receiving drug eluting stents for cardiovascular disease. 

The projects announced in this issue will help to advance the 

understanding of the impact of sex differences on disease diagnosis 

and treatment. 

• Outreach Initiatives 

• Hot Topics 

• Update Extras 

OWH Highlights 

Pregnancy Registry

Medicine Booklets 

Spanish Fact Sheets 

Sex and Gender Course

In addition, OWH continues to translate what we learn from science 

into reliable, easy-to-understand health information for women from 

diverse cultures and regions. For the first time, OWH has made all of 

our consumer fact sheets available in Spanish. Read more about how 

to access these publications and about the results of our creative 

outreach through the “Dear Abby” newspaper column. 

e-Update Archive

FDA Highlights 

FDA Consumer Website 

Links to agency-wide info 

for consumers 

Avandia (Rosiglitazone) Kathleen Uhl, MD 

Information for health 

professionals and patients Assistant Commissioner for Women’s Health 

Safety Information

OWH Research Recalls, withdrawals, and 

safety alerts 

New Fibromyalgia Drug Intramural Research Funding Press release and consumer 

article 

OWH recently announced FY 2007 funding for nine new projects 

through the OWH Intramural Research and Development Program. 

These projects were selected through a highly competitive process 

from a pool of 50 applications. We congratulate the FDA scientists 

listed below for their outstanding submissions and look forward to 

learning more from them about their research. 

Upcoming Meetings

FDA Advisory Committee 

Meetings 

Contact Us 

5600 Fishers Lane 

Room 16-65 Indira Hewlett, Ph.D. - CBER 

Evaluation of gender differences in detection, replication and 

transmissibility of emerging HIV-1 Variants 

Rockville, MD 20857 

301-827-0350 (phone) 

301-827-0926 (fax)

owh@fda.gov Deborah Taylor, Ph.D. - CBER 

The Role of Estrogen in Enhancing Innate Immunity during Viral Infection 
Yongsheng Yang, Ph.D. - CDER 

Identification of Sex Differences in Adverse Outcomes for New Molecular 

Entities (NMEs) Approved from 2000-2002 

Soma Kalb, Ph.D. - CDRH 

Factors Accelerating the Progression of Heart Failure (HF) in Women: 

Implications for Drug Interactions with Medical Devices 

Dinesh Patwardhan, Ph.D. - CDRH 

The Impact of Sex-Based Differences in Atherosclerotic Plaque on the 

Response to Drug Eluting Stent Implantation 

Neera Gopee, Ph.D. - NCTR 

Sex differences in Systemic Lupus Erythematosus (SLE): Effects of a single 

nucleotide polymorphism (SNP) in the prolactin (PRL) gene on individual 

response to prasterone therapy 

Baitang Ning, Ph.D. - NCTR 

Mechanisms of Gender Differences in Aspirin Effects: Metabolizing Enzymes 

and Therapeutic Targets 

Lesley Kerr - ORA 

Development of a Rapid Version of the Tampon Test Method Based on 

21CFR801.430 

Phyllis Wilson - ORA 

Development and Validation of an HPLC method for the Simultaneous 

Determination of Estradiol, Estriol, Estrone and Progesterone in 

Pharmaceutical Preparations

 

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OWH Supports Coronary Stents Research via FDA Critical 

Path Initiative 

OWH is collaborating on several projects that are part of FDA’s 

Critical Path Initiative. Critical Path is an Agency effort to address 

challenging product development issues and identify novel solutions 

through collaboration among FDA, industry, and academia. 

OWH is collaborating with the Agency for Healthcare Research and 

Quality (AHRQ) and the FDA Center for Devices and Radiological 

Health (CDRH) on a retrospective study to assess long term health 

outcomes in patients receiving drug eluting stents and to identify 

risk factors for late thrombosis. 

 

Drug eluting coronary stents are frequently used to treat heart 

disease - the number one killer of women. These stents have been 

known to clot (called thrombosis) immediately or soon after insertion 

into a coronary artery. The occurrence of late thrombosis - 

happening months to years after insertion - is a recently discovered 

problem. The new AHRQ/ FDA funded research project will advance 

our understanding of how late thrombosis may affect women. 
For More Information on Drug Eluting Stents, visit: 

http://www.fda.gov/hearthealth/treatments/medicaldevices/stentqa.

html

Check the OWH website for future updates on the status of this 

research. 

Outreach Initiatives 

FREE – Consumer Health Information in Spanish 

For the first time, all OWH consumer fact sheets are available in 

Spanish. OWH recently released 42 new Spanish-language 

publications on a range of topics including depression, generic drugs, 

heart disease, cosmetics, arthritis, mammography, HIV, and food 

safety. These easy-to-read fact sheets complement OWH’s other 

Spanish language materials on diabetes, menopause, and safe 

medication use. 

OWH invites organizations and consumers to collaborate with us to 

distribute these free publications to women and their families. 

To download copies of the new Spanish fact sheets, visit: 

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

To order free copies in bulk, visit: 

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

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Dear Abby Features OWH Health Information Kit 

In celebration of Mother’s Day and National Women’s Health Week, 

Dear Abby encouraged women to be proactive in their health care by 

ordering the OWH Health Information Kit. Abby readers responded 

by ordering over 1.5 million OWH publications. The kit features 

several OWH medicine booklets, first-of-their kind pamphlets with 

information about all medications to treat depression, high blood 

pressure, high cholesterol and smoking. The kit also includes fact 

sheets on heart disease, food safety, and more. 

 

The Health Information Kits are available online at: 

http://www.pueblo.gsa.gov/rc/d57.htm
Hot Topics 

FDA Issues Rules for Dietary Supplements 

On June 22, 2007, FDA announced a final rule establishing 

regulations to require current good manufacturing practices (cGMP) 

for dietary supplements. Under the final rule, manufacturers are 

required to evaluate the identity, purity, strength, and composition 

of their dietary supplements. If dietary supplements contain 

contaminants or do not contain the dietary ingredient they are 

represented to contain, FDA would consider those products to be 

adulterated or misbranded. 

The aim of the final rule is to prevent inclusion of the wrong 

ingredients, too much or too little of a dietary ingredient, 

contamination by substances such as natural toxins, bacteria, 

pesticides, glass, lead and other heavy metals, as well as improper 

packaging and labeling. 

For More Information 

Full Press Release: 

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01657.html

Backgrounder: http://www.cfsan.fda.gov/~dms/dscgmps7.html

Fact Sheet: http://www.cfsan.fda.gov/~dms/dscgmps6.html

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Continuous Use Contraceptive 

On May 22, 2007, FDA approved Lybrel, the first continuous use 

product for prevention of pregnancy. Lybrel comes in a 28 day-pill 

pack with low-dose combination tablets that contain 90 micrograms 

of a progestin, levonorgestrel, and 20 micrograms of an estrogen, 

ethinyl estradiol, which are active ingredients available in other 

approved oral contraceptives. Other contraceptive pill regimens have 

placebo or pill-free intervals lasting four to seven days that stimulate 

a menstrual cycle. Lybrel is designed to be taken without the 

placebo or pill-free time interval. Women who use Lybrel would not 

have a scheduled menstrual period, but will most likely have 

unplanned, breakthrough, unscheduled bleeding or spotting. The 

occurrence of unscheduled bleeding decreases over time in most 

women who continue to take Lybrel for a full year. 

 Like other available oral contraceptives, Lybrel is effective for 

prevention of pregnancy when used as directed. The risks of using 

Lybrel are similar to the risks of other conventional oral 

contraceptives and include an increased risk of blood clots, heart 

attacks, and strokes. The labeling also carries a warning that 
cigarette smoking increases the risk of serious cardiovascular side 

effects from the use of combination estrogen and progestincontaining contraceptives. 

Because Lybrel users will eliminate their regular periods, it may be 

difficult for women to recognize if they have become pregnant. 

Women should take a pregnancy test if they believe they may be 

pregnant. Women should also discuss contraceptive use, and the 

precautions and warnings for use of the drug product, with their 

doctors or other health care professional. 

For more information, look up Lybrel at Drugs@FDA

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New FDA Consumer Website and E-Newsletter 

FDA launched a new consumer webpage and e-newsletter. The 

webpage provides easy-to-read, product safety news and links to 

useful health information from the FDA and other U.S. government 

agencies. The e-newsletter, entitled “FDA Consumer Health 

Information”, will alert consumers to product approvals, safety 

warnings, and other health news. The e-newsletter replaces the 

agency's print magazine FDA Consumer. 

Consumers are invited to provide comments about the new website 

and newsletter. Email comments to fdaconsumerlist@oc.fda.gov or 

mail to FDA Consumer Health Information, Food and Drug 

Administration, HFI-40, Room 15-A29, Fishers Lane, Rockville, MD 

20857. 

Consumer Website: www.fda.gov/consumer

Free Monthly E-Newsletter: 

www.fda.gov/consumer/consumerenews.html

 

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: 
American Association of Diabetes Educators, August 1-4 – St. Louis, MO 

National Medical Association, August 5-7 – Honolulu, HI 

NACDS Pharmacy & Technology Conference, August 11-15 – Boston, MA 

Minority Women’s Health Summit, August 23-26 – Washington, DC 

National Assoc. of Community Health Centers, August 27-28 – Dallas, TX 

AARP, September 6-8 – Boston, MA 

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We endeavor to provide timely information for your use. 

Feel free to share this with your network, members, constituents, 

and community.