OWH eUpdate 

www.fda.gov/womens January 2009 

In This Issue 

• OWH Research 

• Outreach Initiatives 

• Hot Topics 

• Update Extras 

OWH Highlights 

Join Us 

My Medicines Brochures 

Pregnancy Registries 

Free Publications 

e-Update Archive 

FDA Highlights 

Tainted Weight Loss Pills 

FDA consumer alert 

Surgical Mesh 

Notice on serious 

complications with 

transvaginal placement 

Peanut Butter Recall 

FDA info on Salmonella 

Typhimurium outbreak 

FDA Newsroom 

Public notices, safety alerts, 

media contacts and more 

Contact Us 

5600 Fishers Lane 

Room 16-65 

Rockville, MD 20857 

301-827-0350 (phone) 

301-827-0926 (fax)

owh@fda.gov

Message from the Director 

In this exciting time, OWH is looking forward to new opportunities to 

work with our partners to address the health issues impacting the 

nation’s women. With your help, we will continue our innovative 

strategies for promoting policies and programs that support and 

hopefully improve women’s health. In this update, we highlight our 

ongoing efforts to further dialogue and research on the treatment 

and diagnosis of cardiovascular disease in women. We also 

acknowledge OWH and Agency-wide projects to expand consumer 

access to FDA information. Finally, we provide links to FDA product 

safety information, upcoming meetings, and more. 

I will end by thanking you for your previous support of women’s 

health and reminding you to look to us for continued access to 

timely scientific and consumer health information. 

Kathleen Uhl, MD 

Assistant Commissioner for Women’s Health 

 

OWH Research 

OWH Co-Sponsors 2nd Workshop on Cardiac Devices 

On December 9, 2008, OWH collaborated with FDA’s Center for 

Devices and Radiologic Health (CDRH) to hold a second public 

workshop on the current state of cardiovascular device interventions 

in women. This workshop, like the previous one in June, invited 

experts from academia, industry, FDA, and NIH to discuss sex 

differences in disease presentation, prevalence, diagnosis, and 

testing, as well as the efficacy and/or safety outcomes of 

cardiovascular disease device trials. The workshop also continued 

dialogue on ways to facilitate inclusion of an adequate number of 

men and women in device trials to allow for sex-specific 

performance evaluation in pre-market applications. Both workshops 

represent OWH’s ongoing efforts to promote a greater understanding 

of the differences in cardiovascular disease treatment and 

intervention options between men and women. 
*************************** 

OWH Funded Research Honored with Two Awards 

OWH-funded researcher Dale Tavris was awarded a 2008 Honorable 

Mention at the 24th International Conference on Pharmacoepidemiology and Therapeutic Risk Management in Copenhagen, 

Denmark for being ‘one of three best papers published in 

Pharmacoepidemiology and Drug Safety in 2007’. The paper entitled 

“Risk of Local Adverse Events by Gender Following Cardiac 

Catheterization” [Pharmacoepidemiology and Drug Safety 16 (2): 

125-31, 2007] discussed an OWH-funded study which found that 

following cardiac catheterization, the hemorrhagic events associated 

with hemostasis devices were significantly higher in women. The risk 

varied with the device type. 

An educational exhibit co-developed by OWH-funded researchers, I. 

Kyprianou and S. Park, along with their colleagues in 

CDRH/OSEL/DIAM was honored with a Merit Award at the 

Radiological Society of North America 2008 Conference. The poster 

entitled “Quantitative in Silico Imaging and Biomarker Assessment 

Using Physical and Computational Phantoms : A Review of New Tools 

& Methods Available from the NIBIB/CDRH Lab for the Assessment 

of Medical Imaging Systems” outlined the open source cardiac and 

mammography imaging system simulation, phantoms, and 

statistical analysis tools that they developed for their OWH-funded 

projects. The use of these tools by academia and industry may lead 

to improved diagnosis and better treatment outcomes for patients. 

OWH congratulates the researches for their efforts to increase 

awareness and understanding of sex differences in cardiovascular 

disease diagnosis and treatment. 

Outreach Initiatives 

New Collaboration on Diabetes 

Diabetes Health Network 

OWH will collaborate with the Diabetes Health Network (DHN), an 

independent network that provides free educational television to 

diabetes-focused clinics throughout the U.S. DHN will co-brand and 

reprint over a dozen OWH publications on Diabetes, Cholesterol, 

Heart Disease and other topics to distribute to patients in their 600+ 

member clinics across the country. 
Hot Topics 

FDA Teams with WebMD 

FDA and WebMD are collaborating to expand consumers’ access to 

FDA Health information. The partnership includes: 

A New FDA Portal on WebMD.com 

This website (www.webmd.com/fda) will feature FDA Consumer 

Updates, information on the safety of FDA-regulated products, and 

links to report problems with these products directly to the FDA. In 

addition, WebMD will provide access to FDA public health alerts to all 

WebMD registered users and site visitors that request them. 

FDA Contributions to WebMD the Magazine 

FDA Consumer Updates will also be featured at least three times a 

year in WebMD’s bimonthly magazine which reaches nearly nine 

million consumers in physician office waiting rooms across the 

country. 

Update Extras 

Upcoming FDA Meetings 

Cardiovascular and Renal Drugs Advisory Committee 

Date: February 3, 8:00 a.m. 

Location: Hilton, Washington DC/Silver Spring, Ballroom 

 8727 Colesville Road, Silver Spring, Maryland 

Website: 

http://www.fda.gov/cder/audiences/acspage/meetings/crdac_meeting_

20090203.htm

The committee will discuss new drug application (NDA) 22-307, 

prasugrel hydrochloride film coated oral tablets, 5 milligrams (mg) and 

10 mg, Eli Lilly and Company, for the proposed indication for use in 

acute coronary syndrome 

Risk Communication Advisory Committee 

Date: February 26-27, 8:00 a.m. 

Location: National Transportation Safety Board Conference Center 

 429 L'Enfant Plaza SW, Washington, DC 20594 

Website: 

http://www.fda.gov/oc/advisory/accalendar/2009/OCRCACMtg0226270

9.html 

On both days there will be a discussion of different types of prescription 

drug information currently available to patients in the form of 

Medicating Guides, Patient Package Inserts (PPIs), and Consumer 
Medication Information (CMI). 

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

Presentations

Conference: North American Society For Psychosocial Obstetrics 

 and Gynecology (NASPOG) 

Presentation: FDA’s Pregnancy Labeling: Changes to Improve 

 Information for Prescribing During Pregnancy 

Speaker: Kathleen Uhl 

Date: February 4, 2009 

Location: New Haven, CT 

Conference: Dartmouth Hospital Medical Center Grand Rounds

Presentation: The Intersection of Science, Policy, and Politics of 

 Women’s Health: Effect on FDA-Regulated Products 

Speaker: Kathleen Uhl 

Date: February 27, 2009 

Location: Hanover, NH 

Conference: American Society of Clinical Pharmacology and 

 Therapeutics 

Presentation: Drug Use in Pregnant Women: Clinical Studies and 

 Labeling 

Speaker: Kathleen Uhl 

Date: March 19, 2009 

Location: Washington, DC 

Conference: Women's Health 2009: The 17th Annual Congress 

Poster: Recently approved medical devices: Are females 

 adequately represented in device clinical trials? 

Presenter: Beverly Gallauresi, Lauren DiPaola, Ameeta 

 Parekh, Zimmerman, Kathleen Uhl 

Date: March 27-29, 2009 

Location: Williamsburg, VA 

Conference: Women's Health 2009: The 17th Annual Congress 

Poster: The FDA OWH National College Campaign: 

 Increasing college students’ access to FDA health 

information 

Presenter: Kimberly Thomas

Date: March 27-29, 2009 

Location: Williamsburg, VA

*************************** 
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: 

Sister-To-Sister Women’s Heart Health Fair, February 6 – Washington, DC 

Sister-To-Sister Women’s Heart Health Fair, February 7 – Atlanta, GA 

National Conference on Chronic Disease Prevention, February 23-25 – 

National Harbor, MD 

National Conference on African Americans & AIDS, February 23-24 – 

Philadelphia, PA 

ASA/ NCOA Aging in America Conference, March 16-18 – Las Vegas, NV 

American Counseling Association, March 20-22 – Charlotte, NC 

Planned Parenthood National Conference, March 26-27 – Houston, TX 

Women’s Health Congress, March 27-29 – Williamsburg, VA 

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

We endeavor to provide timely information for your use. 

Please share this with your network, members, constituents, 

and community.