October - Women's Health Update

["FDA Office of Women's Health" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: October - Women's Health Update

October 2015
www.fda.gov/womens

Message from the Director

As you celebrate the many health observances in October, I encourage you to look to FDA for resources. The Office of Women's Health along with FDA’s Centers  and other programs provide videos, publications, and other tools that you can use to educate yourself and the women you serve about FDA-regulated products. In this update, we have highlighted mammography resources, drug safety alerts and campaigns of interest to women and their families.

We have also included several FDA meetings and workshops. The Agency is committed to engaging women’s health stakeholders on a range of issues. So, I hope that you will participate in these public meetings and submit your comments.

Marsha Henderson - Assistant Commissioner for Women’s Health

FDA Women's health highlights

Workshop on Labeling for Lower-Dose Estrogen-Alone Products

On November 10, 2015, FDA will hold a public meeting on the topic of the labeling for lower-dose estrogen products delivered vaginally, intended to treat moderate to severe symptoms of vulvar and vaginal atrophy (VVA) due to menopause. This scientific workshop will provide an opportunity for FDA to seek input from experts on the Boxed Warnings section, estrogen exposure data, and other issues related to the labeling for these products. Register or submit comments by October 16, 2015. View the Meeting Announcement Submit Comments to the Public Docket

Essure Meeting Follow-Up

On September 24, 2015, FDA convened the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to hear expert scientific and clinical opinions on the benefits and risks of the Essure system, a form of permanent birth control (female sterilization), and to hear more from women who have used the device. A brief summary of the meeting is now available online. The docket is also open for public comment until October 24, 2015.

After considering the recommendations of the advisory committee and the public comments made at the meeting and submitted through the docket, the FDA will determine what additional actions, if any, are necessary to assure the safety and effectiveness of the device.

View the Meeting Summary

Submit Comments Online

Mammography Resources

FDA works to ensure quality mammography for the detection of breast cancer in its earliest, most treatable stages. During Breast Cancer Awareness Month, use these FDA resources to encourage the women in your community to get screened.  Download and Share a Mammography Fact Sheet in multiple languages Organize a Pink Ribbon event to promote mammography screening Find a certified mammography facility near you Watch and share a video about mammography

Extras

New Information on Bone Risk with Use of Invokana and Invokamet (canagliflozin)

FDA has strengthened the warning for the type 2 diabetes medicine canagliflozin (Invokana, Invokamet) related to the increased risk of bone fractures, and added new information about decreased bone mineral density. Health care professionals should consider factors that contribute to fracture risk prior to starting patients on canagliflozin. Patients should talk to their health care professionals about factors that may increase their risk for bone fracture. Patients should not stop or change their diabetes medicines without first talking to their health care professional.

View the Drug Safety Communication

FDA Launches Multicultural Youth Tobacco Prevention Campaign

FDA recently launched a national public education campaign to prevent and reduce tobacco use among multicultural youth who identify with the hip-hop peer crowd—a group that is often hard to reach and frequently exposed to pro-tobacco images and messages. While multicultural teens identify with more than one group, the FDA is focusing on those in the hip-hop peer crowd because research estimates that they are more likely to use tobacco than other youth.  The “Fresh Empire” campaign, which targets youth ages 12–17, works to associate living tobacco-free with a hip-hop lifestyle.

Read more about the “Fresh Empire” campaign

FDA Meetings

Sixth Annual Coalition Against Major Diseases (CAMD)/FDA Scientific Workshop

October 15, 2015 - FDA White Oak Campus, Silver Spring, MD

 

Scientific Workshop: Osteoporosis Drug Development

November 4, 2015 - FDA White Oak Campus, Silver Spring, MD

 

Public Meeting on Drug Interactions with Hormonal Contraceptives

November 9, 2015 - FDA White Oak Campus, Silver Spring, MD

 

Vaccines and Related Biological Products Advisory Committee

November 13, 2015 - FDA White Oak Campus, Silver Spring, MD

 

OWH Conference Calendar

The Office of Women’s Health exhibits and presents at conferences across the country to increase awareness of FDA’s women’s health resources and programs. Check out an OWH exhibit booth at one of these conferences:

Nurse Practitioners in Women’s Health, October 14-17 – Salt Lake City, UT

Association of Nurses in AIDS Care, October 29-31– Chicago, IL

American Public Health Association, November 1-4– Chicago, IL

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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