The U.S. Food and Drug Administration declined to approve the use of MDMA-assisted therapy for PTSD, citing safety concerns and methodological problems in the clinical trials. The decision highlights ongoing debates about how to evaluate and regulate psychedelic treatments for mental health conditions.
Auvelity, a combination of dextromethorphan and bupropion, is approved for major depressive disorder in adults. It carries a boxed warning about increased risk of suicidal thoughts and behaviors in pediatric and young adult patients, similar to other antidepressants. Seizures are possible, especially at higher doses. Common side effects include dizziness, nausea, headache, diarrhea, somnolence, dry mouth, sexual dysfunction, hyperhidrosis, anxiety, constipation, decreased appetite, and insomnia.