Office of Women's Health UPDATE, July-August 2004
Susan F. Wood, Ph.D.
The FDA Office of Women's Health continues to work on a wide variety of priority women's health issues, ranging from diabetes, mammography and safe medication use to inclusion of women in clinical studies, medications used during pregnancy and regulatory research. As we look to the future, the FDA OWH will focus new efforts on women and cardiovascular disease, tackling the number one killer of women from a wide range of approaches: research, data analysis, policy and outreach. In this broad priority area, there are numerous instances of sex and gender differences, a clear need for better data and data analysis and connections with other major public health concerns such as fitness, obesity, smoking and diabetes. Products regulated by FDA are important in the prevention and treatment of CVD, and we plan to be funding new initiatives and maintaining current ones over the next several years that will address this critical topic.
Other news in this issue of the OWH Update take note of several awards won by OWH staff and our partners in the community. It's great to see that our work is recognized! We've also launched a new Fitness Challenge within FDA, and I'm inspired by the number of FDA employees who have taken up the challenge!
Finally, FDA has also been in the news regarding the decision to not yet allow the emergency contraception product Plan B to go over the counter as a non-prescription product. We have heard from thousands of women's health advocates and health professionals calling for this product to be allowed to go over the counter and we acknowledge the concerns that have been raised. FDA, in issuing the non-approvable letter, laid out a pathway for approval for the sponsor that leaves open the potential for approval in the future. Your input and feedback is always welcome on this and other important women's health issues that fall within FDA's purview.
Consumer Alert -- Domperidone
The FDA is warning women against using the unapproved drug, domperidone. Some women are using domperidone to increase milk production for breastfeeding. Domperidone is not approved for use in the United States.
Products containing domperidone have been found to cause serious adverse affects including cardiac arrest, cardiac arrhythmias, and sudden death in women in other countries. The impact of domperidone on infant's health has not been determined.
Office of Women's Health launches a Fitness Challenge to encourage FDA Staff to "Step Right Up" to Exercise
The latest research from the U.S. Centers for Disease Control and Prevention (CDC) has revealed that obesity, resulting from poor diet and sedentary lifestyles, will soon become the leading cause of preventable death in the United States. In fact, CDC estimates that 64 percent of all Americans are overweight, including more than 30 percent who are considered obese.
In response to these recent findings, and in alignment with FDA's own Obesity Initiative, the Office of Women's Health (OWH) launched a 100-Day Fitness Challenge on May 10, 2004 to encourage thousands of FDA employees to take action to fight obesity and improve their health. The program is modeled after the President's Challenge (www.presidentschallenge.org) and utilizes pedometers to track daily steps. Program participants can take part either on an individual or team basis to achieve chosen daily walking goals of 4,000 or 10,000 steps. The overarching objective is to help FDA staff make physical activity part of their day and build habits to improve the likelihood of them remaining active well after the conclusion of the competition.An interactive website is used to record steps on a daily step log, track personal/team progress, or compare it with others who have registered as part of the OWH Fitness Challenge. At the conclusion, prizes will be awarded to the most outstanding participants/team, or those who have demonstrated the most improvement over baseline.
To date, there are more than 1800 FDA employees taking part in the program. The Challenge will run from May 30 - September 6, 2004. We are very proud and excited by the response to this initiative and look forward to a very active summer. Clearly FDA is ready to Step Right Up! Happy walking everyone!!!
Take Time to Care Campaign -- More Cities Reaching Out
The Office is in the process of establishing an ongoing relationship with the Conference of Mayors to focus on the dissemination of FDA information regarding chronic illness.Our first venture will be to mail copies our FDA/OWH Pink Ribbon Sunday Guides to their membership of 1,600 mayors across the Nation.We will jointly encourage them to education women about the importance of mammography screening because early detection saves lives.
The final city to partner with us on Take Time To Care About Diabetes is Las Vegas.They have done an exceptional job by forming a Las Vegas TTTC Coalition that has planned activities throughout the year.The lead organization In Las Vegas is Caesar's Entertainment which operates six large hotel/casinos.They are a major employer and are working with a number of other local organizations including the Mayor's Office, Health Department, Parks Service, Culinary Union, and many other hotel/casinos. The Mayor is the Honorary Chair of the planning committee. He held a press conference on April 8th to launch their activities.They have also ordered thousands of TTTC brochures and recipe cards in both English and Spanish for their events. In addition, local clinics and wellness centers have our materials on display.NACDS assisted them in securing assistance from Rite Aid to conduct assessments in their local drug stores.
In order to target the Hispanic community, a high-risk population, they worked with the local Parks Service to host an "Everybody Dance" event. Families were encouraged to participate and free food was provided for all.
Menopausal Hormone Therapy (MHT)
On May, 7 2004, the Menopause and Hormones working group was honored with the Commissioner's Special Citation award for their outstanding teamwork and exceptional cooperation that resulted in the creation of a fact sheet, purse guide, and draft public service announcement concerning the appropriate use of hormone therapy for management of menopausal symptoms.
This year we will have distributed approximately 650,000 pieces of information in both English and Spanish throughout the country.In addition, FDA Public Affairs Specialists will do targeted educational activities in San Juan, U.S. Virgin Islands, New York, Houston, Atlanta, Dallas, Philadelphia, Buffalo, Los Angeles, Indianapolis, in rural counties of New Jersey. These materials were developed over an accelerated six-month time period for use in the Menopause and Hormones communications outreach campaign launch on September 9, 2003. All materials utilized a clear, easy-to-understand format and contained labeling based information summarizing the benefits, risks and uncertainties associated with the use of menopausal hormone therapy (MHT) products. These documents served to clarify some of the uncertainty surrounding MHT and to help ensure that women seeking treatment are informed participants when making the decision with their health care professional as to whether this therapy is right for them.
During mid-May, a contractor was identified to facilitate the development and implementation of a nationwide communications plan to disseminate the above Menopause and Hormones materials to target audiences (English and Spanish speaking peri-menopausal and menopausal) women and then track the effectiveness of those efforts. In the coming weeks we will begin the process of working with the contractor to ensure that essential project goals are addressed in the development of the communications plan approach.
Congratulations to Marsha Henderson for being named a finalist for the 2004 Service to America Career Achievement Medal.
Congratulations to our other award recipients! The Office of Women's Health, FDA, DHHS and outside partners staff are recognized for the following awards:
2004 FDA Science Forum Sigma Xi and Clear Science Communications Outstanding Poster Award -- "Study Pregnant Women? Yes, You Can!"
Office of the Commissioner Award of Excellence -- Report to Congress: Demographic Information and Data Repository (DIDR).
Office of the Commissioner Special Recognition Award -- Innovation and Excellence in the Creation of a new Consumer Information Series of Fact Sheets about FDA Regulated Products for Women and their Families.
Commissioner's Special Citation Menopause and Hormones Campaign Working Group -- For outstanding performance and commitment in review of significant Food and Drug Administration regulations.
Office of Women's HealthFY 2004 Science Program Awardees
Congratulations to the new and continuing research projects that received the FY 2004 OWH Science Program Awards.
Andrew Dayton -- CBER
Gender Dimorphism in HIV Infection in Primary Macrophages and T-Lymphocytes: Kinetics of HIV Replication and efficacy of anti-retroviral agents
Felice D'Agnillo -- CBER
Gender based differences in the vascular response to anthrax toxin: investigation of the role of hormones in an in vitro human endothelial cell culture system
Karen Lechter -- CDER
Gender Differences in the willingness to read and follow patient information
Jove Graham -- CDRH
Development of guidelines for evaluating the appropriateness of vertebroplasty surgery for patients for osteoporosis
Dennis Hinton -- CFSAN
Do phytoestrogens modify the allergic response to food allergens in the newly validated, highly sensitive, in-bred asthmatic rat model?
Eugene Herman -- CDER
Discovery and evaluation of interspecies biomarkers to monitor the early onset and the progression of cardiovascular toxicity associated with Thiazolidinedione compounds used in the treatment of Type 2 Diabetes
Melvin Stratmeyer -- CDRH
Cardiovascular effects of ultrasound contrast agents in intact and ovariectomized female animals
Robert Sprando -- CFSAN
Developmental Toxicity of Androstenedione in rates
June 8, 2004: FDA approves Menostar, a low-dose estrogen patch for use in the prevention of osteoporosis in postmenopausal women.
June 1, 2004: FDA approves first-time generic Metronidazole Topical Cream, 0.75% for the treatment of inflammatory papules and pustules of rosacea. The innovator is MetroCream.
Recalls and Safety Alerts
Updates to Zelnorm Labeling with New Risk Information
The major changes to the Zelnorm label include a new warning about serious consequences of diarrhea, a new precaution about ischemic colitis and other forms of intestinal ischemia, and updated labeling for patients that includes information about these potential side effects and advises that patients should stop taking Zelnorm and contact their doctor. Zelnorm is used for the short-term treatment of women with irritable bowel syndrome (IBS) whose primary bowel symptom is constipation.
New Warnings on some Antipsychotic Drugs
FDA has asked manufacturers of all atypical antipsychotic drugs to add a new warning to the drugs' labels about the increased risk of hyperglycemia and diabetes. Atypical antipsychotics include: Clozaril (clozapine), Risperdal (risperidone), Zyprexa (olanzepine), Seroquel (quetiapine), Geodon (ziprasidone), and Abilify (aripiprazole).
Duragesic Patches Recalled
These patches deliver the opioid fentanyl, used to treat severe chronic pain. These lots are being recalled because of a concern that a small percentage of the patches may leak medication because of an improper seal along one edge of the patch. If the medication leaks from the patch directly onto the patient's skin, overdosing may occur. This can cause nausea, sedation, drowsiness, or potentially life-threatening complications.
New OWH Website
The Office of Women's Health is launching a newly designed website. The new website can be accessed at the same web address: www.fda.gov/womens/.
Conferences and Meetings
National Medical Association Annual Convention: July 31 - August 5, 2004, San Diego, CA
National Association of Diabetes Educators: August 12-14, 2004, Indianapolis, IN
2004 Minority Women's Summit: August 12-15, 2004, Washington, DC