Message from the Director

June is National Safety Month. One way FDA shows its commitment to safety is by providing women and their families with resources to help them make informed choices about their health. As the weather warms up, I encourage you to plan for a safe and healthy summer with tips from our Summer Safety Kit. I hope you will share the information in this update and encourage your community to look to FDA for health and safety information.

Marsha Henderson, Assistant Commissioner for Women's Health

WOMEN’S HEALTH HIGHLIGHTS

Order a Free Summer Safety Kit

Keep your summer safe and healthy with a free publication kit that includes tips from the U.S. Food and Drug Administration, Consumer Product Safety Commission, and Centers for Disease Control and Prevention. Learn how to better manage your medicines and vitamins, plan safe cookouts, prevent mosquito bites, and protect children and guests in the home and at the pool.

Order your free Sumer Safety Kit today!

The FDA Warns Against Using Unapproved Versions of Juvederm

The FDA updated its Dermal Fillers (Soft Tissue Fillers) website to warn the public about unapproved versions of Juvederm, such as Juvederm Ultra 2, 3, or 4, which are being sold and distributed illegally in the U.S.

A list of Juvederm products approved for use in the U.S. can be found on the manufacturer’s website at juvederm.com. The FDA’s Dermal Fillers Approved by the Center for Devices and Radiological Health page also provides a list of products approved for use in the U.S.

Birth Control Pill Recall - Mibela 24 Fe Chewable Tablets by Lupin Pharmaceuticals Inc.

Lupin Pharmaceuticals Inc. announced a recall of lot L600518, Exp 05/18 of Mibelas 24 Fe (Norethindrone Acetate and Ethinyl Estradiol 1 mg/0.02 mg chewable and ferrous fumarate 75 mg) Tablets at the consumer level. A confirmed market complaint indicated a packaging error, where the blister was rotated 180 degrees within the wallet, reversing the weekly tablet orientation and making the lot number and expiration date no longer visible. The first four days of therapy would have had four non-hormonal placebo tablets as opposed to the active tablets.

Consumers who have the affected product should notify their physician and return the product to the pharmacy or place of purchase and contact their physician or healthcare provider if they have experienced any problems that may be related to taking this drug product.

Read the Safety Alert

New Blog from FDA Commissioner on Efforts to Stem Opioid Crisis

The FDA continues to have an important role in addressing the epidemic of opioid addiction. FDA Commissioner, Scott Gottlieb, M.D., shares his first steps toward reducing the epidemic’s scope in his first FDA Voice blog.

Read the Blog Post

June 27th is National HIV Testing Day

FDA plays an active role in supporting products for HIV testing, prevention, and treatment. This HIV Testing Day, get tested at a site in your area and use FDA resources to educate women in your community.

Download and share our Women in HIV factsheet in English, Spanishand Other Languages.
Retweet HIV safety information from @FDAWomen on Twitter on June 27th.

Extras

Public Meeting on Patient-Focused Drug Development for Alopecia Areata

On September 11, 2017, FDA is conducting a public meeting on Patient-Focused Drug Development for alopecia areata. The public meeting is intended to allow FDA to obtain patient perspectives on the impact of alopecia areata, including on daily life, patient views on treatment approaches, and decision factors taken into account when selecting a treatment. This meeting is an exciting opportunity for individuals with alopecia areata to bring their voice to FDA and the drug development process! If you have any questions, please feel free to email patientfocused@fda.hhs.gov.

Learn more and register to attend in-person or via webcast