FDA Alerts
Valproate Anti-seizure Products Contraindicated for Migraine Prevention in Pregnant Women
The US Food and Drug Administration (FDA) is advising healthcare professionals and women that the anti-seizure medication valproate sodium and related products, valproic acid and divalproex sodium, are contraindicated and should not be taken by pregnant women for the prevention of migraine headaches.
FDA Approves Plan B One-Step Emergency Contraceptive
The US Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women’s Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years of age and older.
FDA Approves Diclegis
The US Food and Drug Administration today approved Diclegis (doxylamine succinate and pyridoxine hydrochloride) to treat pregnant women experiencing nausea and vomiting.
FDA Approves Osphena for Postmenopausal Women Experiencing Pain During Sex
The US Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
FDA Approves New Treatment for Late-Stage Breast Cancer
The US Food and Drug Administration today approved Kadcyla (ado-trastuzumab emtansine), a new therapy for patients with HER2-positive, late-stage (metastatic) breast cancer.
FDA Approves new Silicone Gel-Filled Breast Implant
The US Food and Drug Administration today approved the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age.
FDA Approves Breast Tissue Ultrasound
The US Food and Drug Administration approved the first ultrasound device for use in combination with a standard mammography in women with dense breast tissue who have a negative mammogram and no symptoms of breast cancer.
Updated FDA Statement on Hydroxyprogesterone Caproate
FDA approved Makena ( hydroxyprogesterone caproate ) in February 2011 for the reduction of the risk of certain preterm births in women who have had at least one prior preterm birth. Beginning many years before Makena was approved, a version of the active ingredient of Makena has been available to patients whose physicians requested the drug from a pharmacist who compounded the drug.
Risk of Blood Clots Associated With Birth Control
The U.S. Food and Drug Administration (FDA) has completed its review of recent observational ( epidemiologic ) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills.
FDA and FTC to Remove Homeopathic Products from the Market
The U.S. Food and Drug Administration and the Federal Trade Commission (FTC) today issued seven Warning Letters to companies marketing over-the counter (OTC) HCG products that are labeled as “homeopathic” for weight loss.