Office of Women's Health UPDATE, December 2004 - January 2005
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.
"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!
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