OWH Director in
London
OWH director Susan Wood was recently awarded the Atlantic Fellowship
in Public Policy, sponsored by the British Foreign and Commonwealth
Office and the British Council. During the fellowship, Dr.
Wood will study and evaluate women's health policy in the United
Kingdom for 8 months. Beginning Nov. 1, 2004, she is temporarily
assigned to the United Kingdom Department of Health, Women's
Health and Maternity Policy Team based in London. While at
the UK Department of Health, Dr. Wood will work on issues related
to osteoporosis, menopause, domestic violence and drug development.
She will return to the FDA Office of Women's Health next summer,
bringing back new perspectives and approaches to women's health.
Marsha Henderson will serve as the Acting Assistant Commissioner
for Women's Health during Dr. Wood's absence.
Consumer Alert - Mifeprex
On, November 15, 2004, the FDA issued a statement
about important safety changes to the labeling for mifepristone
(also known as Mifeprex or RU-486) distributed by Danco Laboratories.
Mifeprex is approved for the termination of early pregnancies.
The FDA and the manufacturer were alerted to reports of
serious complications following the use of the Mifeprex.
In response, new warnings were added to the black
box labeling on the drug. The new label warns health care
professionals and consumers about the risk of serious bacterial
infection, bleeding, sepsis, and death. Additional information
is available at http://www.fda.gov/cder/drug/infopage/mifepristone/default.htm.
OWH Marked the end of the Fitness Challenge
The Office of Women's Health celebrated the end of
the 100-day fitness challenge to FDA staff with an awards ceremony
and luncheon for the grand prize winners on October 27th. During
the ceremony, awards were given to the individuals and teams
who walked the most steps from May 30th to September 6th. Individual
prizes were also awarded to the participants who demonstrated
the most improvement over the course of the challenge. FDA
Acting Commissioner Lester Crawford was on hand to congratulate
the fitness challenge participants.
Over 1,000 FDA employees from around the country participated
in the fitness challenge. The goal of the challenge was to
encourage FDA employees to increase their level of daily physical
activity.
Outreach: Promoting Mammography
OWH and the FDA Public Affairs Office in Puerto Rico co-sponsored
an island-wide Pink Ribbon Sunday campaign in October.
The campaign was a collaboration between the FDA and the Puerto
Rico Alliance for the Promotion of Mammography which has
over 50 member organizations. The Pink Ribbon Sunday campaign
promoted breast cancer awareness at more than 1600 churches
on the island. Most churches observed Pink Ribbon Sunday
on October 31, 2004, but programs and activities will continue
through December. In addition, over 1,000 women and their
families attended campaign activities at the 7th Congress
of Breast Cancer Survivors. OWH health education fact sheets
and other materials were distributed at all campaign events.
The campaign was widely supported by local government officials
and the press. The First Lady of Puerto Rico delivered
a proclamation honoring the Pink Ribbon Sunday campaign
that was signed by the Governor. Five regional newspapers
printed articles regarding the Pink Ribbon Sunday initiative.
Several radio programs were also held to promote Pink Ribbon
related activities. Special thanks were extended to Nilda
Villegas, FDA Public Affairs Specialist in Puerto, and
alliance partners for their efforts at making this campaign
a success.
Menopause Campaign
"Lowest dose that helps, Shortest time needed" is
the message being delivered in the national outreach phase
of the Menopause and Hormones information campaign. In August,
OWH launched the second phase of the MHT project. The MHT project
aims to raise public awareness about the benefits and risks
associated with menopause hormone therapy and to encourage
women to learn more about treatment options for menopause symptoms.
OWH has joined forces with The Media Network, Inc., a communications
contractor, and other external partners to develop a radio,
print and on-line advertising campaign. The media campaign
highlighted the English and Spanish versions of the OWH menopause
fact sheets and a public service announcement that were developed
last year by the MHT working group. A radio tour was held during
the month of September (National Menopause Month) under the
campaign theme "Menopause and Hormones: What Can You
Believe?" An online advertising campaign and nationwide
article releases are planned for the coming weeks with additional
radio broadcasts to follow in January/February 2005. We are
excited about the campaign progress so far and look forward
to further community outreach plans for 2005. Stay tuned!
Awards
Congratulations to Marsha Henderson and the entire OWH Outreach
Team for receiving the Consumer Choice
Award from the GSA's Federal Citizen Information Center. The award recognized the
Office of Women's Health for "extraordinary service
for a decade as a clear voice, empowering millions of consumers
by providing reliable health information". This was the
first time in five years that the FCIC has given this award.
Since 1999, FCIC has distributed about 3 million OWH brochures
and fact sheets from the Take Time To
Care Campaign. Consumers
can call FCIC to receive free bulk copies of OWH materials.
FCIC has also distributed OWH publications in Congressional
and IRS mailings.
Recalls and Safety Alerts
September 2004: Vioxx
Vioxx was first approved in 1999 for the reduction of pain
and inflammation caused by osteoarthritis and for the treatment
of menstrual pain. At the time of approval, it was hoped that
this pain medication would cause fewer stomach problems than
other pain medicines. In late September 2004, the maker of
Vioxx voluntarily removed it from the market because recent
studies showed long-term treatment with Vioxx caused an increased
risk of heart attack and stroke.
Drug safety has been a constant concern of FDA's OWH.
In September 2004 OWH funded a research fellow to utilize a
new statistical approach to look for sex differences in adverse
drug events. This approach can be used on either pre-market
or post-market data and could provide the agency with early
signals of drug related problems. Preliminary analysis of the
pre-market clinical studies on Vioxx show that more women were
enrolled in the clinical studies than men but women were not
at a greater risk for heart attack compared to men. Investigations
on the safety of Vioxx and several other FDA-approved medicines
are continuing with a goal of developing tools to identify
subpopulations at risk for adverse events prior to product
approval.
October, 2004: Antidepressants
The FDA directed the manufacturers of antidepressant medications
to add a "black box" warning to drug labeling.
The new warning alerts health professionals to the increased
risk of suicidal thoughts and behavior in children and adolescents
taking antidepressants. In addition to the new warning, a
Patient Medication Guide describing the risks associated
with antidepressants will be distributed to consumers taking
these medications.
November, 2004: Depo-Provera
The FDA alerted physicians, health care practitioners, and
patients about the risk of loss of bone density associated
with prolonged use of Depo-Provera, an injectable contraceptive.
A new black box warning - which highlights serious concerns
- states that a woman only should use Depo-Provera as a long-term
birth control method (e.g., more than 2 years) if other methods
prove inadequate. FDA and Pfizer, the drug's manufacturer
said that the drug, which has been used for decades for birth
control, remains a safe and effective contraceptive. In addition
to adding this serious warning to the label, Pfizer is issuing
a Dear Health Care Practitioner letter. The drug company
said it will incorporate the new information into the patient
information sheet distributed with the drug.
Conferences and Meetings
Female Sexual Dysfunction
The FDA's Advisory Committee for Reproductive Health
Drugs held a meeting in December to discuss a new product
designed to treat hypoactive sexual desire disorder in surgically
menopausal women who are taking estrogen therapy. Hypoactive
sexual desire disorder is considered to be a deficiency or
absence of sexual thoughts and desire for sexual activity
that causes a woman personal distress. The new product under
review is named Intrinsa. Intrinsa is a testosterone skin
patch that was developed by Proctor and Gamble. The background
materials for the advisory committee meeting on Intrinsa
are available on the Internet at http://www.fda.gov/ or
http://www.fda.gov/ohrms/dockets/ac/cder04.html.
- Food
and Drug Law Institute, December 1-3, 2004 - Washington,
DC
- American Heart Association 2nd International Conference on
Women, Heart Disease & Stroke, February 16 - 19, 2005 - Orlando, FL
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