The Office of Women's Health e-Update highlights women's health initiatives, meetings, and regulatory safety information from the U.S. Food and Drug Administration (FDA). The e-Update is disseminated via email to the public.
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Message from the Director
Update on FDA’s Evaluation of Essure
FDA issued an update on the status of the Agency’s evaluation of adverse events that have been reported for the Essure System, a form of permanent birth control (female sterilization). FDA is reviewing information from the panel meeting, the public docket, as well as additional medical literature and adverse event reports which have been published or received since the panel meeting. This is a high priority issue for the Agency. FDA anticipates communicating our actions publically at the end of February 2016.
Resources for Women with Diabetes
FDA’s Women and Diabetes webpage highlights videos, easy-to-read publications, and other resources that can be used to educate women about the safe use of FDA-approved medicines and medical devices for diabetes management. The webpage also features links to food safety tips and information on diabetes during pregnancy.
Blood-thinning drug does not change risk of death
A FDA review has determined that long-term use of the blood-thinning drug Plavix (clopidogrel) does not increase or decrease overall risk of death in patients with, or at risk for, heart disease. FDA’s evaluation of the Dual Antiplatelet Therapy (DAPT)1 trial and several other clinical trials also does not suggest that clopidogrel increases the risk of cancer or death from cancer.
Patients should not stop taking clopidogrel or other antiplatelet medicines because doing so may result in an increased risk of heart attacks and blood clots. Talk with your health care professional if you have any questions or concerns about clopidogrel. Health care professionals should consider the benefits and risks of available antiplatelet medicines before starting treatment.
December 2, 2015 - FDA White Oak Campus, Silver Spring, MD