FDA Alerts

Drug Safety Communication: SSRI use during pregnancy
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 ).
FDA Drug Safety Communication: Diflucan
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.
FDA: Unapproved Emergency Birth Control May Be Ineffective, Unsafe
The U.S. Food and Drug Administration (FDA) is warning U.S. consumers not to use the emergency birth control medicine labeled as Evital . These products may be counterfeit versions of the “morning after pill” and may not be safe or effective in preventing pregnancy.   Evital has not been approved by the FDA for use in the United States. This potentially ineffective and suspect counterfeit emergency birth control may also be in distribution in some Hispanic communities in the United States. The packaging label of the potentially ineffective and suspect counterfeit version says, �...
FDA Safety Alert: Women's Health
The U.S. Food and Drug Administration (FDA) is informing the public about new information that is being assessed as part of their ongoing safety review of birth control pills that contain drospirenone . This review will further evaluate the risk of blood clots in women who use these products.
FDA Statement on Makena
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.
Motherhood is About to Make You a Little Crazier
FDA notified healthcare professionals that the Pregnancy section of drug labels for the entire class of antipsychotic drugs has been updated.
Dangerous Drug for Pregnant Women
The FDA is warning that terbutaline administered by injection or through an infusion pump should not be used in pregnant women for prevention of, or for prolonged (beyond 48-72 hours) treatment of preterm labor.
Making Sure They Don't Come Early
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.