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OWH Celebrates a Milestone
This year marks the 10th anniversary of the Food and Drug Administration
(FDA) Office of Women's Health (OWH). We have had many successes during the
past decade. While our mission remains the same, we begin the next phase in
the progression of OWH with a new look. The new OWH logo features women from
an array of cultural backgrounds. Each woman represents a different regulatory
function of the FDA: medical devices, drugs, biological and radiological products,
cosmetics, and food. This new logo will be featured on our traveling exhibits
and outreach materials. With our new look and renewed focus, we will continue
to fund seminal research studies and outreach efforts to protect and advance
the health of the nation's women.
OWH Welcomes New Staff Member
Alison Lemon joins OWH as a Public Health Educator. She brings an expertise
in designing low-literacy health education materials. Alison received her
masters in health science from Johns Hopkins University in 2001. She also
holds a BA in public relations and psychology from Syracuse University. Alison
has previously worked with the FDA as both an intern and a contractor. In
addition to her role at FDA, Alison is an adjunct professor at George Washington
University. She is also a certified yoga and Pilates instructor.
Drug Safety Board
On February 15, 2005, FDA announced the formation of a new Drug Safety Oversight
Board to manage drug safety issues for the Agency. The board will consist
of FDA staff as well as experts from other Health and Human Services agencies.
The new board will also provide up-to-date safety information to health providers
and consumers.
More information about the Drug Safety Oversight
Board.
FDA/NCI Fellowship
FDA and the National Cancer Institute have created a new Research and Regulatory
Review Fellowship to train researchers in molecular oncology. The Fellowships
will include four different training programs for scientists and physicians
working with molecular oncology products. The programs aim to bridge the gap
between scientific research and the regulatory process.
More information
about the FDA/NCI fellowship.
State-of-the-Science Conference on Menopause
The National Institutes of Health convened a State-of-the-Science Conference
on the Management of Menopause-Related Symptoms on March 21-23, 2005 in Bethesda,
MD. After weighing all of the scientific evidence, an independent 12-member
panel presented the following conclusions:
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Menopause is the permanent cessation of menstrual periods
that occurs naturally around age 52. Many women have few or no symptoms;
these women are not in need of medical treatment.
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Premenopausal or perimenopausual women who have menopause
induced by surgery, chemotherapy, or radiation are more like to experience
bothersome and even disabling symptoms. These women deserve safe and effective
treatment.
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It is difficult to determine which symptoms are truly
associated with menopause as opposed to aging.
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Vasomotor symptoms are reported with high frequency.
Estrogen, either by itself or with progestins, is the most consistently
effective therapy for these symptoms. However, the Women's Health Initiative
Study identified a defined risk associated with these therapies. Decision
making for women regarding treatment for menopausal symptoms requires personal
knowledge and balancing of these risks.
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There are many potential alternatives to estrogen. However,
their effectiveness and long-term safety need to be studied in rigorous
clinical trials in diverse populations of women.
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To address the charge to this panel, much more research
is needed to clearly define the natural history of menopause, associated
symptoms, and effective and safe treatments for bothersome symptoms.
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The state of the science in management of menopausal
symptoms should be reassessed periodically.
Additional information about the conference.
Menopause and Hormones Campaign
The communications plan for the Menopause and Hormones information campaign
is now in full swing! Spearheaded by The Media Network, the campaign has included
print, radio, and Internet advertisements as well as community outreach activities.
Over 26,000 menopause kits were distributed through the HHS National Women's
Health Information Center. English language print advertisements were placed
in national publications with an audience reach of approximately 5.9 million
people. Additionally, English and Spanish language fact sheets and discussion
guides were distributed through FDA partners including state women's health
coordinators and state FDA public affairs specialists. State level e-mail
campaigns resulted in 17,796 total hits to the menopause website, and a FDA
editorial on menopause also appeared in 148 newspapers in 14 different states.
All campaign related materials are available for FDA partners to download
and use.
Diabetes Conference in the US Virgin Islands
OWH sponsored the Women and Diabetes Symposium for Health Professionals on
February 23, 2005 and February 25, 2005 in St. Thomas and St. Croix, respectively.
The conference was coordinated by the San Juan District Public Affairs Specialists,
Ruth Marcano and Nilda Villegas, in partnership with the Puerto Rico Diabetes
Association, the U.S. Virgin Islands' Diabetes Program of the Department of
Health, the University of Puerto Rico's Women's Health Center, and others.
The conference offered expert speakers from the Centers for Disease Control
in Atlanta as well as universities and health professional groups from throughout
the region. The symposium was a groundbreaking initiative that addressed issues
relating to the increasing prevalence of diabetes in the Caribbean. Approximately
200 health care providers and educators attended the conferences.
Southern Women's Show
Acting Assistant Commissioner for Women's Health, Marsha Henderson, and Atlanta
Public Affairs Specialist, JoAnn Pittman, participated in the 2nd Annual Southern
Women's Show in Savannah, Georgia on February 17th-19, 2005. A cooking presentation
was conducted with chefs from the Kroger national grocery chain. The presentation
discussed the "Cooking for Women" initiative that aims to provide consumers
with food safety and health information. The cooking demonstration featured
dishes from the Office of Women's Health diabetes recipe cards. Kroger staff
provided participants with food samples, and FDA provided door prizes to encourage
healthy lifestyle behavior. More than 600 participated in the conference.
The diabetes recipe cards and brochures featured at this event can be ordered
in English or Spanish by calling 1-888-8PUEBLO.
Recalls/Safety Alerts
B-Sure brand One-Step Home Pregnancy Test -- On March 25, 2005, Harmony Brands,
Oak Park, Michigan, a national distributor of health, cosmetic and other consumer
products, voluntarily recalled its B-Sure brand One-Step Home Pregnancy Test,
because its safety and efficacy can no longer be assured. The tests can be
identified by the product label notation "B-sure" pregnancy test. Additional
information identifying the product can be found on the Harmony Brands Web site.
Soft Cheeses -- The FDA is advising that some soft cheeses made with raw milk
present a health risk, especially to high-risk groups, such as pregnant women,
newborns, older adults, and people with weakened immune systems. Such raw
milk soft cheeses can cause several serious infectious diseases including
listeriosis, brucellosis, salmonellosis and tuberculosis. Recently, cases
of tuberculosis in New York City have been linked to consumption of queso
fresco style cheeses, either imported from Mexico or consumed in Mexico, contaminated
with Mycobacterium bovis, the causative agent.
Crestor -- The FDA issued a public health advisory, a patient information
sheet, and a corresponding healthcare professional information sheet further
explaining the identified risks and benefits of Crestor (Rosuvastatin calcium),
a cholesterol-lowering drug. FDA is providing up-to-date information about
the risk of rhabdomyolysis (serious muscle damage) in patients taking Crestor
as well as other statin drugs. This is a well-known, rare adverse effect of
all statins. Review of data available to date from controlled trials as well
as the latest post-marketing safety information indicates that patients taking
recommended doses of Crestor have a similar risk of rhabdomyolysis as patients
on other statin cholesterol treatments. The revised labeling notes that this
may be particularly important for treating Asian American patients, since
clinical trial data suggest that they (along with patients on cyclosporine
or patients with severe renal insufficiency) may have higher drug levels and
therefore be at greater risk for muscle injury due to Crestor than the general
population.
Tysabri -- The FDA issued a public health advisory to inform patients and
health care providers about the suspended marketing of Tysabri (nataluzimab)
while the Agency and the manufacturer evaluate two serious adverse events
reported with its use. FDA received a report from Biogen Idec, the manufacturer
of Tysabri, of one confirmed fatal case and one possible case of progressive
multifocal leukoencephalopathy (PML) in patients receiving Tysabri for MS.
FDA was given preliminary information about these cases by Biogen, Idec on
February 18, 2005. Details became available to FDA the next week. PML is a
rare, serious progressive neurologic disease usually occurring in immunosuppressed
patients. There is no known effective treatment for PML. Although the relationship
between Tysabri and PML is not known at this time, because of the serious
and often fatal nature of PML, FDA concurred with the company that the drug
be voluntarily withdrawn from marketing and that the use of Tysabri in clinical
trials be suspended until more is known.
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