Read about Research on Heart Disease in Women and more

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

Title: Read about Research on Heart Disease in Women and more

February eUpdate from FDA Office of Women's Health

February 2017

www.fda.gov/womens

Message from the Director

Through our research and outreach, OWH has been a leader in helping to improve the prevention, diagnosis, and treatment of heart disease and related conditions in women. Our national outreach program provides free heart health education tools for health professionals and community leaders to use to teach women about reducing their risk and making informed decisions about their heart health.�

For over 20 years, OWH has also supported research to better understand cardiovascular diseases in women and to improve the participation of diverse women in cardiovascular trials. The results of our completed research have contributed to FDA guidance for industry and workshops to foster dialogue and collaboration with public and private partners in the U.S. and internationally. As we build on lessons learned, we are funding studies with the Critical Path Initiative to improve the prediction and prevention of drug-induced heart arrhythmias in women. This research can help potentially improve drug development and safety for both women and men.

During American Heart Month, visit our heart research pages and use the educational resources in this update to help improve heart health outcomes for women. I also encourage you to learn about our 2017 research grants which will help to protect and promote the health of women and support product safety.�

Marsha Henderson, Assistant Commissioner for Women�s Health

WOMEN�S HEALTH HIGHLIGHTS

2017 OWH Research Grants

Research remains an important tool to support FDA�s assessment of the safety and efficacy of medications and other products. �Each year, OWH participates in the Office of the Chief Scientist Research Grants Harmonization process to identify women�s research projects for funding. This year, OWH selected 7 new research projects for funding based on OWH�s Women�s Health�Research Roadmap. The new research strategy and funding structure enable OWH to better support larger studies and cross-center collaborative projects.

The outcomes of the research projects will help FDA develop innovative approaches to identify and evaluate the impact of sex differences in the safety and efficacy of medical products used by women.�

View the 2017 list of OWH-funded research

New Resources for American Heart Month

OWH offers resources to help women make informed decisions about their heart health. Our new Heart Health toolkit features sample messages you can use on Twitter, Facebook, newsletters and blogs. Share these resources to encourage women in your community to protect their hearts.

• Download the new Heart Health toolkit
• Print and share the Heart Health for Women Fact Sheet in English, Spanish and Other Languages
• Download a booklet to help you talk to your doctor about heart related diseases like diabetes, high cholesterol and high blood pressure
• Retweet heart healthy tips from @FDAWomen on Twitter

Updated Heart Disease Tools for Researchers

Since 1994, OWH has supported 69 studies that have contributed to the understanding of cardiovascular diseases in women and the development of FDA guidance. Our Research on Heart Disease in Women webpage has been updated to include more research summaries and an overview of the three phases of OWH-funded research on the effects of drugs on women�s heart health.

• Visit the Research on Heart Disease in Women webpage

• Find out how OWH-funded Research on QT Prolongation is Making a Difference
• Get Cardiovascular Medicine and Device Information
• Learn about other OWH-funded research

Extras

FDA confirms elevated levels of belladonna in certain homeopathic teething products

FDA announced that its laboratory analysis found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label. The agency is warning consumers that homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children and urges consumers not to use these products.

Read the press release

Meetings

Participate in upcoming FDA Public Meetings.

Joint Devices Advisory Committee Meeting: Ophthalmic and Risk Communication

March 17, 2017, 7:30 am to 4:00 pm

Hilton Washington, DC North/Gaithersburg, Gaithersburg, MD

Please share this update with your network, members, constituents, and community.
FDA Office of Women's Health,�owh@xxxxxxx, 301�796�9440
10903 New Hampshire Avenue, WO32�Room 2333, Silver Spring, MD 20993

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