Message from the Director
National Wear Red Day® is an important day for women’s health. As you all know, heart disease is the number one killer of women in the U.S. Throughout our history, the FDA Office of Women’s Health (OWH) has supported research and outreach projects that advance the understanding and treatment of heart disease in women. In this update, you will learn about some of our new heart related activities. In addition, you will find links to other OWH and FDA women’s health resources for consumers and health professionals.
Marsha Henderson, MRCP
Assistant Commissioner for Women’s Health (Acting)
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OWH Research
SAFE-PCI for Women Protocol Launch
FDA is collaborating with the Cardiac Safety Research Consortium (CSRC) to sponsor a second TransRadial Education and Therapy Thinktank Meeting (TREATT). TREATT II will convene faculty experts from academia, industry and government to discuss the SAFE-PCI for Women Protocol. The meeting will be held March 7, 2011 from 8:00 a.m. - 6:00 p.m. at the White Oak FDA Campus.
Percutaneous coronary interventions (PCI) have historically been performed through the femoral arterial access. Higher bleeding rates have been reported in women. Attempts have been made to reduce bleeding through alternate procedures such as the radial artery access. OWH Research Director, Dr. Ameeta Parekh, will give a presentation on the importance of assessing safety in women who undergo PCI procedures.
Learn More about the Meeting
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Gender-Specific Medicine Lecture Available Online
Last fall, OWH sponsored a one-day scientific symposium on women’s health for FDA scientists and reviewers. The keynote lecture at the symposium is now available to the public. In her talk entitled "Gender-Specific Medicine and the Genome: A Complex and Evolving Tale", Marianne J. Legato, M.D. discussed the impact of genomics on sex differences and gender-specific medicine. Dr. Legato is an internationally known expert in gender-specific medicine.
The symposium was the second in a series of OWH scientific seminars for FDA staff designed to facilitate dialogue and collaboration on regulatory research addressing sex differences and health conditions that solely or disproportionately impact women. Through these meetings, OWH aims to encourage the sharing of research findings that may not only impact Agency regulatory decision-making but also public health.
View Dr. Marianne Legato’s Guest Lecture (September 14, 2010)
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OWH Outreach
New HRSA Training Module
The FDA Office of Women’s Health (OWH), in partnership with the HRSA Patient Safety and Clinical Pharmacy Services Collaborative (PSPC), has launched a new, web-based training course for health professionals. The medication safety module entitled “Does My Patient Understand?” highlights best practices for improving patient/provider communication and addressing factors such as low health literacy that limit a patient’s ability to safely use their medications. The course also explains how OWH consumer health materials can be used in clinical settings to improve patient education, compliance, and health outcomes.
The module provides one hour of continuing education credit for pharmacists, nurses, and physicians. The course can be accessed at:
http://pssc.aphanet.org/trainingmodules/FDAdoesmypatientunderstand.htm
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Heart Health for Women Website
OWH is working to raise awareness about heart disease in women through its Heart Health for Women website. The site features OWH consumer fact sheets on heart disease and booklets on other chronic conditions that impact cardiovascular health such as hypertension, smoking, and lipid control. OWH has also compiled links to other FDA and HHS resources on heart health and health eating. Check out all of the resources at: www.fda.gov/womenshearthealth
To Learn More:
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Diabetes PSA Now Available in English and Spanish
OWH has developed a new video public service announcement (PSA) entitled “Women and Diabetes”. The PSA provides tips to help women with diabetes safely use their diabetes medicines. The video is available in English and Spanish along with other free diabetes materials on the OWH diabetes website.
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FDA Highlights
FDA Newsroom
FDA approves drug to reduce risk of preterm birth in at-risk pregnant women
On February 4, FDA approved Makena (hydroxyprogesterone caproate) injection to reduce the risk of preterm delivery before 37 weeks of pregnancy, in pregnant women with a history of at least one spontaneous preterm birth. The drug is not intended for use in women with a multiple pregnancy, such as a twin pregnancy, or other risk factors for preterm birth.
A health care provider would give Makena once a week by injection into the hip. Treatment should begin at 16 weeks and no later than 21 weeks of pregnancy. The most common side effects reported with Makena included pain, swelling, or itching at the injection site; hives; nausea; and diarrhea.
To Learn More:
FDA Press Release
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Possible Link between Breast Implants and a Rare Cancer
On January 26, FDA announced a possible association between saline and silicone gel-filled breast implants and anaplastic large cell lymphoma (ALCL), a very rare type of cancer. Data reviewed by the FDA suggest that patients with breast implants may have a very small but significant risk of ALCL in the scar capsule adjacent to the implant.
The FDA is recommending that health care professionals and women pay close attention to breast implants and do the following:
- Health care professionals are requested to report all confirmed cases of ALCL in women with breast implants to Medwatch, the FDA’s safety information and adverse event reporting program. Report online or by calling 800-332-1088.
- Health care professionals should consider the possibility of ALCL if a patient has late onset, persistent fluid around the implant (peri-implant seroma). In cases of implant seroma, send fresh seroma fluid for pathology tests to rule out ALCL.
- There is no need for women with breast implants to change their routine medical care and follow-up. ALCL is very rare; it has occurred in only a very small number of the millions of women who have breast implants. Although not specific to ALCL, health care providers should follow standard medical recommendations.
- Women should monitor their breast implants and contact their doctor if they notice any changes.
- Women who are considering breast implant surgery should discuss the risks and benefits with their health care provider.
To Learn More:
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HHS Highlights
A woman suffers a heart attack every minute in the United States. But according to a 2009 American Heart Association (AHA) survey, only half of women said they would call 9-1-1 if they thought they were having a heart attack – and many women did not even recognize several key symptoms. The HHS Office on Women’s Health (OWH) and its partners launched a new national initiative - Make the Call, Don’t Miss A Beat to increase awareness and recognition of the seven most common heart attack symptoms among women and to encourage the use of the 9-1-1 emergency response system when these symptoms occur.
Learn More about the Make the Call, Don’t Miss A Beat
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FDA Advisory Committee Meetings
Advisory Committee Calendar
Tobacco Products Scientific Advisory Committee
Dates: February 10, 2011 1:00 p.m. – 5:00 p.m./ February 11, 2011 8:00 a.m. – 5:00 p.m.
Location: Center for Tobacco Products, 9200 Corporate Blvd., Rockville, MD
On February 10, 2011, the Committee will continue to do the following: (1) Receive updates from the Menthol Report Subcommittee and (2) receive and discuss presentations regarding the data requested by the Committee at the March 30 through 31, 2010, meeting of the Tobacco Products Scientific Advisory Committee.
On February 11, 2011, the subcommittee will receive presentations and discuss the timelines and structure of the Tobacco Products Scientific Advisory Committee’s required report to the Secretary of Health and Human Services regarding the impact of use of menthol in cigarettes on the public health.
February 10th Meeting Announcement
February 11th Meeting Announcement
Pulmonary-Allergy Drugs Advisory Committee
Date: March 8, 2011
Time: 8:00 a.m. to 5:00 p.m.
Location: FDA White Oak Campus, Building 31, the Great Room (Rm. 1503), White Oak Conference Center, 10903 New Hampshire Avenue, Silver Spring, MD
The Committee will discuss new drug application (NDA) No. 22-383, indacaterol maleate (Arcapta™ Neohaler™) by Novartis Pharmaceuticals Corporation, for the long-term once daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema
**************************Other Meetings of Interest:
Anesthetic and Life Support Drugs Advisory Committee – March 10, 2011
Food Advisory Committee Meeting– March 30-31, 2011
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Update Extras
Conferences
OWH exhibits at conferences across the country to increase awareness of OWH programs and resources and to increase dissemination of the over 50 OWH fact sheets and brochures available for consumers. Visit the OWH exhibit booth at these upcoming conferences:
International Stroke Conference, February 8-10 – Los Angeles, CA
American Pharmacists Association, March 25-28 – Seattle, WA
Women’s Health 2010, April 1 - 3– Crystal City, VA
National Student Nurses Association, April 6-10 – Salt Lake City, UT
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Want more information from the FDA Office of Women’s Health?
Follow OWH on Twitter: http://twitter.com/fdawomen
Visit the OWH website: www.fda.gov/womens
Attend an OWH Presentation: OWH
Presentations
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Please share this update with your network, members, constituents, and community.
FDA Office of Women’s Health
10903 New Hampshire Avenue
WO32 - Room 2333
Silver Spring, MD 20993-0002
301-796-9440
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U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420
