Which medication was reinstated by the FDA for severe depression?

• A. Orphan Drug Act
• B. Labeled Indications
• C. Black Box Warnings
• D. Tranylcypromine

Answer: (D)

When severe depression doesn’t respond to standard antidepressants, clinicians may turn to older agents with a distinct mechanism for refractory cases. Tranylcypromine is a monoamine oxidase inhibitor (MAOI) that has been used for major depressive disorder, especially in severe or treatment-resistant depression. By irreversibly inhibiting the enzyme monoamine oxidase, it increases levels of mood-related neurotransmitters—norepinephrine, serotonin, and dopamine—in the brain, which can help lift mood when other medications have failed. This is why it’s the medication among the options that fits treating severe depression.

The other choices aren’t medications used to treat depression. The Orphan Drug Act is legislation that provides incentives to develop drugs for rare diseases. Labeled Indications and Black Box Warnings refer to labeling concepts—what a drug is approved to treat and the strongest safety warnings—rather than an actual drug.