What medication requires special criteria for adolescents aged 16-18 and must be accompanied by a signed FDA consent form?

Methadone is the medication that requires special criteria for adolescents aged 16-18, necessitating a signed FDA consent form. This requirement stems from methadone's classification as a Schedule II controlled substance, due to its potential for abuse and the severe consequences of overdose.

In the context of addiction treatment, particularly opioid use disorder, methadone is used as part of a comprehensive treatment plan that includes counseling and psychosocial support. The consent form is essential because it helps ensure that both the patient and their guardians are fully informed about the risks, benefits, and potential for dependency associated with the use of methadone. This is particularly important in younger populations who may have different responses to the medication compared to adults.

While other medications like bupropion, naltrexone, and disulfiram have their own considerations regarding use in adolescents or certain populations, they do not have the same stringent criteria concerning FDA consent as methadone does. Thus, the need for a signed consent form emphasizes the careful oversight required when prescribing methadone to adolescents, reflecting a commitment to patient safety and adherence to regulatory standards.