OWH eUpdate 

www.fda.gov/womens Summer 2008 

In This Issue 

• OWH Research 

• Outreach Initiatives 

• Hot Topics 

• Update Extras 

OWH Highlights 

Join Us 

Pregnancy Registries 

Order Spanish Materials 

Birth Control Booklet 

e-Update Archive 

FDA Highlights 

Tomato Warnings 

Latest on Salmonella 

Saintpaul Outbreak 

HPV Vaccine 

New package insert and 

patient information 

Drug Information Index 

Info on select FDA-approved 

drugs 

FDA Newsroom 

Public notices, safety alerts, 

media contacts and more 

Sun Safety 

Consumer tips for sun safety 

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 

Throughout the summer, OWH is continuing to promote scientific 

dialogue, research, and educational initiatives on vital women’s 

health issues. I encourage you to read about a recent public 

workshop on trials for medical devices used in the treatment of 

cardiovascular disease, as well as, the results of our successful 

consumer outreach through the Dear Abby column and the OWH 

national college campaign. Also, don’t forget to check out the Hot 

Topics articles and other links to up-to-date information on FDA 

actions related to the new genetic test for patients with breast 

cancer, new warnings for antimicrobial drugs, and the ongoing 

Salmonella Saintpaul outbreak. 

 

Kathleen Uhl, MD 

Assistant Commissioner for Women’s Health 

 

OWH Research 

OWH Co-Sponsors Workshop on Cardiac Devices 

On June 2, 2008, OWH collaborated with FDA's Center for Devices 

and Radiologic Health (CDRH) to hold a public workshop to gather 

input from industry, academia, and regulatory experts regarding the 

challenges related to the enrollment of women in pre and post 

market cardiac device trials. Meeting participants discussed 

strategies for improving recruitment and ensuring that adequate 

numbers of women are enrolled in these trials to support subgroup 

analyses. They also offered suggestions for ways to facilitate the 

inclusion of data from sex/gender-specific subgroup analyses in 

product labeling. The information gathered in the workshop will 

potentially inform FDA efforts to develop a draft guidance for 

industry. 

This workshop is a part of OWH’s continuing efforts to influence 

future FDA policy development related to the analysis of sex/gender 

differences and to promote greater understanding of the treatment 

of cardiovascular disease in women. Check future eUpdates for 
additional information about a follow-up meeting. 

Outreach Initiatives 

OWH College Campaign Goes National 

OWH launched its college campaign to increase college students’ 

access to information on vital women’s health issues such as HIV 

prevention, depression, pap tests, sunscreens, contraception, and 

safe medication use. Throughout the year, OWH has expanded its 

outreach to Women’s Colleges, Historically Black Colleges and 

Universities, Hispanic Serving Institutions, and other universities 

across the country. Participating schools receive a free display stand 

and free publications for their health center or health education 

programs. 

OWH materials are being distributed at 70 colleges and universities 

nationwide including the University of Mississippi, Spelman College, 

Mount Holyoke College, Tuskegee University, and the University of 

Alaska - Anchorage. 

Colleges or universities interested in joining the campaign should 

complete the online OWH collaboration form and fax it to the 

OWH office at 301-827-0926. 

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Dear Abby Recognizes OWH Health and Beauty Kit 

Once again, the nationally syndicated Dear Abby column has 

recognized OWH during National Women’s Health Week. Dear Abby 

announced the availability of the new OWH Health and Beauty 

Information Kit. The kit was designed to help women make informed 

choices about the health and beauty products they use everyday. It 

included OWH consumer fact sheets on Botox, Contact Lens Care, 

Cosmetics, and other topics. 

Dear Abby readers ordered over 122,000 English and Spanish kits 

through the Federal Citizen Information Center. 

Hot Topics 

FDA Approves New Genetic Test for Patients with Breast 

Cancer 

On July 8, 2008, FDA announced the approval of a novel genetic test 
for determining whether patients with breast cancer are good 

candidates for treatment with the drug Herceptin (trastuzumab). The 

SPOT-Light HER2 CISH kit is a test that measures the number of 

copies of the HER2 gene in tumor tissue. This gene regulates the 

growth of cancer cells. The SPOT-Light test counts the number of 

HER2 genes in a small sample of removed tumor. 

To view the full press release, visit: 

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01857.html 

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

FDA Requests Boxed Warnings on Fluoroquinolone 

Antimicrobial Drugs 

FDA is requiring manufacturers of fluoroquinolone antimicrobial 

drugs to add a Boxed Warning to the product labeling concerning the 

increased risk of tendinitis and tendon rupture in patients taking 

these drugs. Manufacturers of the drugs will also have to provide a 

Medication Guide to patients about possible side effects. The new 

Boxed Warning and Medication Guide would strengthen warning 

information already included in product labeling. 

Fluoroquinolones are drugs approved for the treatment or prevention 

of certain bacterial infections. The medications involved in this action 

are: Cipro and generic ciprofloxacin, Cipro XR and Proquin XR 

(ciprofloxacin extended release), Factive (gemifloxacin), Levaquin 

(levofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin), and 

Floxin and generic ofloxacin. 

The risk of developing fluoroquinolone-associated tendinitis and 

tendon rupture is further increased in people older than 60, in those 

taking corticosteroid drugs, and in kidney, heart, and lung transplant 

recipients. 

FDA Information for Healthcare Professionals: 

http://www.fda.gov/cder/drug/InfoSheets/HCP/fluoroquinolonesHCP.htm 

Full FDA Press Release: 

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01858.html 

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

Proposed Changes to Pregnancy and Lactation Labeling 

In May 2008, FDA announced proposed revisions to prescription 

drug labeling on the effects of medicines used during pregnancy and 

breast-feeding. Current pregnancy labeling uses five categories—A, 

B, C, D, and X. The proposed rule would remove the categories from 

the labeling of all drug products. Under FDA’s proposed rule, the 
labeling would contain two subsections: one on pregnancy and one 

on lactation. Both the pregnancy and lactation subsections would 

have three principal components: a risk summary, a clinical 

considerations section, and a data section. 

The proposed rule and other information on pregnancy and lactation 

labeling can be viewed at: 

http://www.fda.gov/cder/regulatory/pregnancy_labeling/default.htm

 

Comments on the proposed rule should be submitted by August 27, 

2008 at: 

http://www.regulations.gov/fdmspublic/component/main?main=Doc

ketDetail&d=FDA-2006-N-0515 

Update Extras 

Upcoming FDA Meetings 

Arthritis Advisory Committee 

Topic: Actemra (tocilizumab) for Rheumatoid Arthritis 

Date: July 29, 2008 

Time: 8:30 a.m. to 3:30 p.m. 

Location: Hilton Washington DC/Silver Spring, The Ballrooms, 

 8727 Colesville Rd., Silver Spring, MD 

Website: http://edocket.access.gpo.gov/2008/E8-12646.htm

Other Meetings 

NIH Office of Research on Women’s Health Seminar Series 

Topic: Sex and Gender Research On Pain 

Date: July 17, 2008 

Time: 1:00 p.m. to 3:00 p.m. 

Location: Lipsett Amphitheater, Building 10, NIH Campus 

 Bethesda, MD 

Contact: Marsha Love at lovem@od.nih.gov 

What a Difference an X Makes: The State of Women's Health Research

Date: October 3, 2008 

Time: 9:00 a.m. - 4:30 p.m. 

Location: Washington, D.C. 

Website: Agenda and Registration

FDA Speakers: 

Kathleen Uhl - Sex Differences and the FDA Critical Path Initiative

Katie O'Callahan - Sex Differences and Devices and Diagnostics 

*************************** 
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 Council of La Raza, July 12-15 – San Diego, CA 

NAACP, July 12-17 – Cincinnati, OH 

National Association of Hispanic Nurses, July 16-18 – Boston, MA 

Delta Sigma Theta Public Service Conf., July 24-30 – Orlando, FL 

National Medical Association, July 27-29 – Atlanta, GA 

National Urban League, July 30-Aug 2 – Orlando, FL 

National Black Nurses Association, August 4-8 – Las Vegas, NV 

American Assoc. of Diabetes Educators, August 6-9 – Washington, DC 

American Psychological Association, August 14-17 – Boston, MA 

NACDS Pharmacy & Technology Conf., August 23-27 – San Diego, CA 

AARP, September 4-6 – Washington, DC 

National Association of Community Health Centers, September 14-16 – 

New Orleans, LA

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