FDA Alerts
New Schizophrenia Rx Approved
On July 10, the U.S. Food and Drug Administration approved Rexulti (brexpiprazole) tablets to treat adults with schizophrenia and as an add-on treatment to an antidepressant medication to treat adults with major depressive disorder (MDD).
Cymbalta Goes Generic
The U.S. Food and Drug Administration today approved the first generic versions of Cymbalta (duloxetine delayed-release capsules), a prescription medicine used to treat depression and other conditions.
FDA Approves New Drug to Treat Major Depressive Disorder
The US Food and Drug Administration today approved Brintellix (vortioxetine) to treat adults with major depressive disorder.
Celexa and Risk of Arrhythmia
The U.S. Food and Drug Administration (FDA) is clarifying dosing and warning recommendations for the antidepressant Celexa ( citalopram hydrobromide ; also available in generic form).
Generic Lexapro Approved
The U.S. Food and Drug Administration approved the first generic Lexapro ( escitalopram tablets) to treat both depression and generalized anxiety disorder in adults.
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: Celexa
The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and patients that the antidepressant Celexa ( citalopram hydrobromide ; also marketed as generics) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the electrical activity of the heart. Studies did not show a benefit in the treatment of depression at doses higher than 40 mg per day.
FDA Drug Safety Communication: Celexa
The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and patients that the antidepressant Celexa ( citalopram hydrobromide ; also marketed as generics) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the electrical activity of the heart. Studies did not show a benefit in the treatment of depression at doses higher than 40 mg per day.
Previously, the citalopram drug label stated that certain patients may require a dose of 60 mg per day.
Facts about Celexa ( citalopram hydrobromide )
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FDA Drug Safety Communication: Methylene blue (UPDATE)
The U.S. Food and Drug Administration (FDA) has received reports of serious central nervous system (CNS) reactions when the drug methylene blue is given to patients taking psychiatric medications that work through the serotonin system of the brain ( serotonergic psychiatric medications).
Viibryd Approved for Major Depression
Viibryd has just been approved by the FDA to treat adults with major depression, a mental disorder which affects around 15 million people in the United States.