Director's Message
Susan F. Wood, Ph.D.

Welcome to the FDA Office of Women's Health Update. This summary highlights the activities of our outreach and science programs. Read on for the latest information about regulatory actions and upcoming meetings of interest to women's health. Many issues of this publication are available online in the OWH Update Archive.

Take Time To Care About Diabetes

Diabetes is now considered an epidemic in the U.S., with 17 million Americans now diagnosed with diabetes. An additional 5.9 million have diabetes, but do not know it.

Type II diabetes, a.k.a. non-insulin dependent diabetes, is on the rise and is associated with obesity and sedentary lifestyles, both prevalent in American culture.

Diabetes complications include: heart disease, strokes, vision impairment/blindness, kidney disease, and possibility of amputation.

FDA regulates food, drugs and devices used for the management and treatment of diabetes and ensures their safety and effectiveness.

Why Diabetes and Women?

Accounting for 52 percent of all adult diabetes cases, women who develop diabetes are at a greater risk of also developing heart disease. Women with prior histories of gestational diabetes have an increased risk of developing Type II diabetes later in life.

Other risk factors include: over age 40; family history of diabetes; and ethnicity (i.e. African American, Hispanic/Latino, Asian American/Pacific Islander, and Native American).

Outreach Activities: Take Time to Care Diabetes Awareness Campaign

On May 2, 2002, FDA OWH launched a nationwide campaign, "Take Time to Care...About Diabetes, " to raise public awareness about the disease and its effects on women and their families."

In alignment with Healthy People 2010 objectives, this campaign utilizes a recognition-based approach as a means to help women understand diabetes and take proactive steps to improve their family's health, as well as their own.

Co-sponsored by the National Association of Chain Drug Stores (NACDS) and the American Diabetes Association (ADA), the campaign promotes three important messages:

• Get tested for diabetes,
• Watch what you eat and get exercise, and
• Use medicines wisely.

As part of the campaign, free diabetes related materials which include an easy-to-read brochure, wallet sized calendars, and quick and healthy recipes are being distributed at participating grocery stores and pharmacies in the following eleven cities: Atlanta, GA; Baltimore, MD; Chicago, IL; Dallas, TX; Detroit, MI; Indianapolis, IN; Los Angeles, CA; Miami, FL; New Orleans, LA; Philadelphia, PA and Phoenix, AZ.

Take Time To Care...About Diabetes literature is also available through the Federal Consumer Information Center by calling 1-888-8-PUEBLO. All printed copies are free.

For additional information on the TTTC...About Diabetes campaign, please visit our Website.

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OWH's New Pregnancy Registry Site

Women can now make informed decisions regarding their medications effects during their pregnancy. OWH's new pregnancy registry Website provides information on organizations conducting pregnancy registries, how to locate ongoing pregnancy registries and receive drug exposure results and how to participate.

This registry is an ongoing study enrolling and gathering information from women who are currently or have been exposed to medications during their pregnancy.

Please visit our Website.

Science Program Research Funded

Congratulations to the following individuals who received an award for FY 2002, under our competitive peer-reviewed science program:

• D. Verthelyi, Center for Biologics Evaluation and Research
  "Effect of Sex Hormones on the immune response to CpG ODN"
• ML Chen, Center for Drug Evaluation and Research
  "Gender Effect on the Assessment of Bioavailability and Bioequivalence in Bioequivalence trials."
• D. Tavris, Center for Devices and Radiological Health
  "Incidence and attributable risk of serious AE's and death associated with the use of hemostasis devices by gender."
• R. Sprando, Center for Food Safety and Applied Nutrition
  "Characterization of the effect of prepubertal/pubertal exposure of androstenedione on female reproductive health"- (Preliminary & Experiment III study)
• A. Harris, National Center for Toxicological Research
  "Development and characterization of conditionally immortalized human primary hepatocyte cell lines from Female and male donors" --Phase I

New Approvals

• Breast brachytherapy (5/6/02): type of targeted internal radiation designed to radiate just the tumor site instead of the whole breast.
• Botox (4/15/02): to temporarily improve the moderate to severe frown lines appearance between the eyebrows (glabellar lines)

Recalls and Safety Alerts

• Accutane (4/02): used for acne treatment; label modification due to depression, psychosis and, rarely, suicidal ideation, suicide attempts and suicide associations.
• Actos and Avandia (4/26/02): used for treating patients with Type II diabetes; modified due to cardiovascular risks associated with insulin use.
• Vioxx (4/11/02): used for treating patients with osteoarthritis, rheumatoid arthritis, acute pain, and primary dysmenorrhea; label modification due to labeling to describe new cardiovascular and gastroenterological safety information.
• Kava Herbal Extracts (2/12/02): under investigation; used for relaxation, insomnia, postmenstrual syndrome (PMS); may be associated with liver toxicity, hepatitis, cirrhosis and liver failure.

**Coming Soon**

"The Prevention Guide: A Lifetime to Good Health, Your Guide to Staying Healthy"
Order your copy now. Call NWHIC at 1-800-994-9662.

Other Women's Health News

• Mammography Screening
  HHS Secretary Tommy G. Thompson announced an updated U.S. Preventive Services Task Force (USPSTF) calling for mammography screening every one to two years for women ages 40 and over. The National Cancer Institute (NCI) also has reaffirmed its support for mammography. Breast cancer is the most common cancer among women in the U.S. For recommendations and materials, visit the Website or call 1-800-358-9295.
• Protein Patterns May Identify Ovarian Cancer
  Joint study by FDA and NCI scientists suggests, using special software, protein patterns found in patients' blood serum may reflect the presence of ovarian cancer.
• National Women's Health Week (NWHW)
  Held the week following Mother's Day, this national initiative is supported by an alliance of women's health organizations to raise awareness about preventative steps women can take and incorporate into their daily lives. Visit www.4woman.gov/WHW/ for a list of activities

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