Brintellix approved for major depressive disorder
(HealthDay)—Brintellix (vortioxetine) has been approved by the U.S. Food and Drug Administration to treat adults with major depressive disorder, often referred to as depression.
The disorder may have symptoms including lack of interest in usual activities, weight or appetite changes, sleep problems, feelings of guilt or worthlessness, lack of concentration and thoughts of suicide.
In seven clinical studies, Brintellix proved effective in treating depression and in preventing future episodes, the FDA said in a news release. The most common side effects observed included nausea, constipation and vomiting.
Brintellix has a boxed label warning that antidepressants can raise the risk of suicidal thoughts among some users, especially among children, adolescents and adults aged 18 to 24. Doctors should carefully monitor users of Brintellix and similar drugs, especially during initial treatment, the FDA advised.
Brintellix is marketed by Takeda Pharmaceuticals and Lunbeck, both based in Deerfield, Ill.
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