FDA Alerts

FDA Review of Possible Risks of Pain Medicine Use During Pregnancy
FDA is aware of and understands the concerns arising from recent reports questioning the safety of prescription and over-the-counter (OTC) pain medicines when used during pregnancy.
FDA Issues Advice on Eating Fish
The U.S. Food and Drug Administration and the U.S. Environmental Protection Agency today issued draft updated advice on fish consumption.
FDA Approves the First Non-Hormonal Treatment for Hot Flashes Associated with Menopause
The US Food and Drug Administration today approved Brisdelle (paroxetine) to treat moderate to severe hot flashes (vasomotor symptoms) associated with menopause.
FDA Approves Plan B One-Step Emergency Contraceptive for Use Without a Prescription
Today, the US Food and Drug Administration announced it has approved the use of Plan B One-Step (levonorgestrel) as a nonprescription product for all women of child-bearing potential.
FDA Recommends Against Prolonged Use of Magnesium Sulfate to Stop Pre-term Labor
The US Food and Drug Administration (FDA) is advising healthcare professionals against using magnesium sulfate injection for more than 5-7 days to stop pre-term labor in pregnant women.
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.
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.