Dear Abby Features
FDA OWH Take Time To Care Information Series
Dear Abby:
Your readers have a history of responding enthusiastically
to the good advice you share with them. Because of that, I'm
writing on behalf of the Food and Drug Administration's Office
of Women's Health and the Federal Citizen Information Center
to offer our new, free Women's Health Information Kit. It contains
some of Uncle Sam's best advice on more than a dozen health
topics that concern today's women.
All of these materials are part of the Take
Time to Care information series. Between caring for their
families and staying busy at work, women are always on the go.
That is why it's more important than ever for women to "take
time to care" about their own health. Whether they're managing
their medications, looking for ways to minimize their risk of
heart attack or learning about menopause -- they'll find some
great advice in our Women's Health Information Kit.
Thanks, Abby, for always providing timely, practical and
good advice to your readers. And please ask them to place their
orders now, because supplies are limited.
Marsha Henderson
Assistant Commissioner for Women's Health (Acting)
Food and Drug Administration
* * * * *
I'm delighted to spread the word. Readers, as many of you know,
the information in these special kits for women has been compiled
by the government at taxpayer expense. That's why they're offered
at no cost to you -- not even postage. I have reviewed the kit,
and it contains a gold mine of handy-dandy information on topics
that include heart disease (the leading killer of women in the
United States), mammography, Pap smears, menopause, depression,
strokes -- and more.
There are three ways to order this TTTC Women's Health Information
Kit. Order online at http://www.pueblo.gsa.gov.
Send your name and address to Women's Health Information kit,
Pueblo, Colo. 81009. Or call toll-free 888-878-3256 weekdays
8 a.m. to 8 p.m. and ask for the Women's Health Information
Kit. If you're interested, don't wait. Do it today.
Dear Abby is written by Abigail Van Buren,
also known as Jeanne Phillips, and was founded by her mother,
Pauline Phillips. Write Dear Abby at www.DearAbby.com or P.O.
Box 69440, Los Angeles, Calif. 90069.
2005 Universal Press Syndicate
During the first two weeks of the offer, FCIC's Pueblo received
an overwhelming 164,789 consumer requests for the Women's Health
Information Kit. Thousands of requests for the materials continue
to pour in daily.
Pregnant Women and Bioterrorism
In 2002, OWH and the Center for Drug Evaluation and Research
jointly funded a study to collect safety information on pregnant
women exposed to medicines that would be used to treat infections
caused by agents of bioterrorism. The study, conducted at Vanderbilt
University by William Cooper, was recently completed. Using
claims data in the Tennessee Medicaid database, Dr. Cooper was
able to show that exposure to ciprofloxacin, amoxicillin, azirothromycin
or doxycycline did not increase the risk of birth defects in
the infants. Women who might need these anti-infective medicines
during pregnancy should be reassured that these medicines will
not harm the fetus.
Demographic Information and Data Repository DIDR
The DIDR are a set of data repositories
containing labeling, reviews, study data and protocols that
will allow reviewers and researchers to query and build reports
so they may conduct more informed assessments and better manage
the risks of products for all sub-populations. The DIDR will
also allow OWH to track participation in clinical trials, monitor
gender analysis in reviews and conduct research on women's health
issues. This data will be analyzed and used to develop policy
and standards for data collection and analysis, clinical trial
design, and the dissemination of information regarding the risks
associated with use of medical products.
OWH is developing Review Templates to enable storage and reporting
on components of reviews. In May the proof of concept for a
Review Template was tested and programming modifications are
being made in June/July.
American Diabetes Association Diabetes Expo
JoAnn Pittman, the Atlanta District Pubic Affairs Specialist
collaborated with Kroger School of Cooking and Kroger Pharmacy
at the Expo, held in Atlanta, GA. The event was a trade show
and interactive health fair. FDA presented four exhibits including
OWH, CFSAN, CDER, and MedWatch. Pittman and Kroger chef and
pharmacists interacted with participants and discussed FDA outreach
programs including Take Time To CareÖUse Medicines Wisely, Calories
Count, Fight BAC!, and Be An Active Member of Your Health Care
Team. A serving of OWH Pineapple Salsa Recipe was a hit. More
than 1800 visited the combined booths.
FDA First Centennial Planning Meeting
The FDA Southeast Centennial Team and FDA History Office held
the First Centennial Planning Meeting with its stakeholders
at the FDA Atlanta Complex. The purpose of the meeting was to
offer a unique opportunity for FDA and other stakeholders to
broaden public awareness of FDA's responsibilities and to increase
the Agency's ability to carry out its mission. More than 40
participated in an interactive dialogue. Attendees represented
government, industry, associations, health professionals, academia,
and corporate businesses. The Centennial Celebration will kick-off
in January 2006.
The Role of the Pharmacist in Diabetes Health Care
Florida District Public Affairs Specialist Faye Bronner presented
"The Role of the Pharmacist in Diabetes Health Care"
at a Pharmacy Council Workshop. The event was sponsored by the
Pharmacists Planning Service, Inc. (PPSI) and was held at the
American Pharmacy Association (APhA) annual meeting. Bronner
was one of six speakers on the diabetes program and she encouraged
pharmacist, physicians and student pharmacists to visit FDA's
Web site on diabetes and to utilize FDA's Medwatch Reporting
Program.
Promotores Trained in Texas
OWH funded a Train-the-Trainer Course on Chronic Disease Prevention
for health promoters. About 60 health promoters and observers
representing diverse community based organizations, federal,
city, and county municipalities attended the two-day event.
The keynote speaker was Dr. Mary Luna-Hollen, Director of the
Promotores Program at the University of Texas Health Science
Center School of Public Health. Promotores learned about diabetes,
cardiovascular disease, cancer, and menopause hormone therapy.
Approvals
FDA approved a manufacturing supplement for the Today Sponge
(nonoxynol 9), an already approved OTC contraceptive product.
This approved manufacturing supplement allowed the Today Sponge
to re-enter the U.S. market for the first time since 1994.
Rithron-XR Coronary Stent System consists of a stent and a
stent delivery catheter. The stent, an expandable, slotted,
stainless steel tube, is mounted over a deflated balloon attached
to the end of a long, thin, flexible tube (stent delivery catheter).
The stent has gold markers that help the surgeon place it in
an artery. The stent and markers are completely coated with
silicon carbide. The stent is permanently implanted within the
coronary artery, acting as a support (scaffold) for the newly
opened section of vessel.
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