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.

The U.S. Food and Drug Administration and the U.S. Environmental Protection Agency today issued draft updated advice on fish consumption.

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.

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.

The US Food and Drug Administration today approved Diclegis (doxylamine succinate and pyridoxine hydrochloride) to treat pregnant women experiencing nausea and vomiting.

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.

The U.S. Food and Drug Administration (FDA) is updating the public on the use of selective serotonin reuptake inhibitor ( SSRI ) antidepressants by women during pregnancy and the potential risk of a rare heart and lung condition known as persistent pulmonary hypertension of the newborn ( PPHN ).

The U.S. Food and Drug Administration (FDA) is informing the public that chronic, high doses (400-800 mg/day) of the antifungal drug Diflucan ( fluconazole ) may be associated with a rare and distinct set of birth defects in infants whose mothers were treated with the drug during the first trimester of pregnancy.

On February 3, 2011, the U.S. Food and Drug Administration approved the drug Makena ( hydroxyprogesterone caproate ) for the reduction of the risk of certain preterm births in women who have had at least one prior preterm birth.

The FDA has approved Makena™ ( hydroxyprogesterone caproate ) to reduce the risk of preterm delivery before 37 weeks of pregnancy, in pregnant women with a history of at least one spontaneous preterm birth.