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New Depression Drug Approved by FDA

By October 18, 2013July 17th, 2019Uncategorized

The FDA recently approved the use of a new antidepressant medication called Brintellix (vortioxetine). The drug will be used to treat major depressive disorder (MDD). Depression is a condition that affects millions of people worldwide. It is generally treated with antidepressants like Paxil, which has been proven dangerous. This new Brintellix may prove safer to use.

“Major depressive disorder can be disabling and can keep a person from functioning normally,” said Mitchell Mathis, M.D., acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Since medications affect everyone differently, it is important to have a variety of treatment options available for patients who suffer from depression.”

Brintellix was previously examined in six clinical studies that analyzed how the drug worked in adults with MDD. The trials compared the reaction of the patients to use of Brintellix vs. placebos. The most common side effects expressed in those trials with Brintellix use included nausea, constipation and vomiting. Brintellix will be offered in doses of 5 mg, 10 mg, 15 mg and 20 mg.

Brintellix does come equipped with a Boxed Warning and a Medication Guide that explains that the pills can increase suicidal thoughts and behavior in patients aged 13-24 when the drug is started. The effect does not appear to be the same in adults older than 24. This new drug may be better given only to adults, but the side effects are similar to those included with regular antidepressants. Antidepressants being used now — like Paxil — have proven to be very dangerous to use, and are also highly addictive. Drugs like Paxil are part of a class of drug called SSRIs which affect the brain’s serotonin levels, which are related directly to the brain’s mood. Paxil has been linked to serious side effects, including violent and suicidal thoughts and behavior, birth defects and gastrointestinal bleeding.