January Women's Health Update

www.fda.gov/womens

January 2018

Message from the Director

It’s a new year and the Office of Women’s Health is excited to continue advancing science and innovation to improve the health of women and their families. As we look ahead, OWH will prioritize initiatives that support the 2018 Strategic Policy Roadmap, led by Commissioner Dr. Gottlieb, to advance FDA’s public health mission. 

We began the year by continuing to empower women to make better and more informed decisions about their health by committing to healthy habits. We have also continued to connect pregnant women, new mothers, and their healthcare providers to safety resources through our Resources for You and Your Baby Initiative. As you observe National Birth Defects Prevention Month, I encourage you to visit our Medicine and Pregnancy webpage and share the resources in this update to help pregnant women start a conversation with their healthcare providers about the medicines they take. 

I hope you will continue to look to us in 2018 as we advance the understanding of women’s health issues, launch new research, and lead outreach activities to help women make safe and healthier choices about FDA products. We depend on each of you to help us amplify these important messages to women across the country. Please link to FDA’s women’s health web content and share our messages on Twitter, Pinterest and in your newsletters. You are a key part of helping us improve the health of women.

 

Marsha Henderson, Associate Commissioner for Women's Health

Resources for Pregnant Women

January is National Birth Defects Prevention Month. Encourage expectant mothers to make informed decisions about their medicines with these FDA resources.  Download the Pregnancy Social Media Toolkit and the Medicine and Pregnancy fact sheet.  Link to the FDA Pregnancy webpage, www.fda.gov/pregnancy.  Learn how pregnancy registries can help improve safety information for pregnant women.  Read the FDA consumer update, “Adding Folic Acid to Corn Masa Flour May Prevent Birth Defects.”

FDA Approves First Treatment for Breast Cancer with a Certain Inherited Genetic Mutation

FDA expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasized) and whose tumors have a specific inherited (germline) genetic mutation, making it the first drug in its class (PARP inhibitor) approved to treat breast cancer, and it is the first time any drug has been approved to treat certain patients with metastatic breast cancer who have a “BRCA” gene mutation. Read the FDA News Release.

Prescription Opioid Cough and Cold Medicines: FDA Requires Labeling Changes

FDA is requiring safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone to limit the use of these products to adults 18 years and older. The Agency has determined that the risks of these medicines outweigh their benefits in children younger than 18. FDA is also requiring the addition of a “Boxed Warning” with safety information about the risks of misuse, abuse, and addiction leading to overdose, death, and slowed or difficult breathing.   Read the FDA Drug Safety Communication.

FDA's New Patient Engagement Collaborative

The FDA and the Clinical Trials Transformation Initiative (CTTI) will be working together to create a new work group with patient advocacy organizations to talk about patient engagement at the FDA. Visit the FDA Patient Engagement Collaborative webpage. Read the Federal Register Notice. Read the blog, “You Spoke, FDA Listened: New Patient Engagement Collaborative, Call for Nominations.”

Advancing Health through Innovation: New Drug Therapy Approvals of 2017

FDA released Advancing Health through Innovation: New Drug Therapy Approvals of 2017, a summary of the Center for Drug Evaluation and Research’s (CDER’s) 2017 important new drug approvals that serve to advance public health. These approvals will benefit patients affected by a wide range of rare diseases, neurological conditions, infectious diseases, cancers, and many other medical conditions. Read the report, “Advancing Health through Innovation: New Drug Approvals and Other Drug Therapy Advances of 2017.” Read the blog, “Many “Firsts” for CDER’s 2017 Drug Approvals Reflect Innovation and Enhanced Patient Care.”

New Website Survey: Give Us Feedback

Tell us about your experience using the For Women section of FDA’s website. A feedback button has been added to select women’s health webpages to gather information that we can use to improve our web content.  Visit www.fda.gov/womenshealthpubs and give us your feedback.

Kick Off a Healthy New Year

Commit to a healthier you in 2018. Get started with our 4 tips to help you and your family build healthy habits.  Read and share, “4 Tips for a Healthy New Year.”

Tips to Quit Smoking

FDA has tips to help women quit smoking. Use these FDA resources to help you and others in your community make a plan to quit smoking.  Download the Smoking: Medicines To Help You Quit booklet. Read the consumer update, "4 Tips to Quit Smoking." Visit the Women’s Health and Smoking webpage (FDA Center for Tobacco Products).

It's Not Too Late to Get Your Flu Shot

Haven’t had your flu shot yet? It’s not too late. And there are still good reasons to get one. An annual seasonal flu vaccine is the best way to reduce your risk of getting sick and spreading it to others. Read the FDA consumer update, “It's Not Too Late to Get Your Flu Shot.”

Participate in Upcoming FDA Public Meetings

Public Meeting: Opioid Policy Steering Committee: Prescribing Information - Exploring a Strategy for Implementation January 30, 2018, 8:30 am to 4:30 pm (EST) FDA White Oak Campus, Silver Spring, MD Public Workshop: 10th Annual Sentinel Initiative  February 7 – 8, 2018 - Webcast and Presentation Slides are available for the Public Workshop: Self Collection Devices for Pap Test, held on January 11, 2018.