After much debate the following medications carry the "black box warnings" on the labels of the bottles. These are the strongest warnings that the FDA requires, a step away from pulling the medications.

• Adderall Tablets (mixed salts of a single entity amphetamine product)
• Adderall XR (mixed salts of a single entity amphetamine product) Extended-Release Capsules
• Concerta (methylphenidate hydrochloride) Extended-Release Tablets
• Daytrana (methylphenidate) Transdermal System
• Desoxyn (methamphetamine hydrochloride) Tablets Label (will be updated soon)
• Dexedrine (dextroamphetamine sulfate) Spansule Capsules and Tablets
• Focalin (dexmethylphenidate hydrochloride) Tablets
• Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules
• Metadate CD (methylphenidate hydrochloride) Extended-Release Capsules
• Methylin (methylphenidate hydrochloride) Oral Solution
• Methylin (methylphenidate hydrochloride) Chewable Tablets
• Ritalin (methylphenidate hydrochloride) Tablets
• Ritalin SR (methylphenidate hydrochloride) Sustained-Release Tablets
• Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules
• Strattera (atomoxetine hydrochloride) Capsules

Warnings for Amphetamine, Dextroamphetamine, Lisdexamfetamine dismesylate, Methamphetamine, Mixed Salts of a Single Entity Amphetamine Products

Adderall, Adderall XR, Desoxyn, and Dexedrine (SR)

• High abuse/diversion potential: Amphetamines have a high potential for abuse. Particular attention should be paid to the possibility of subjects obtaining amphetamines for non-therapeutic use or distribution to others, and the drugs should be prescribed or dispensed sparingly.
• Drug dependence: Administration of amphetmaines for prolonged periods of time may lead to drug dependence and must be avoided.
• Serious Adverse Events: Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events

• Chronic abusive use can lead to a marked tolerance and psychological dependence with varying degree of abnormal behavior
• Frank psychotic episodes can occur, especially with parenteral abuse.

Methylphenidate Products: Concerta, Metadate, Ritalin, Daytrana
Dexmethylphenidate Products: Focalin

• Should be given cautiously to patients with a history of drug dependence or alcoholism.
• Careful supervision required during drug withdrawal from abusive use since severe depression may occur.
• Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

Methylphenidate Products: Methylin Products

• Should be given cautiously to emotionally unstable patients, such as those with a history of drug dependence or alcoholism, because such patients may increase dosage on their own initiative.
• Careful supervision required during drug withdrawal, since severe depression as well as the effects of chronic over-activity can be unmasked.
• Long term follow-up may be required because of the patient's basic personality disturbances.











Strattera Atomoxetine

Strattera Suicidal Ideation in Children and Adults



• Atomoxetine increased the risk of suicidal ideation in short-term studies in children or adolescents with attention-deficit/hyperactivity disorder (ADHD).
• Anyone considering the use of atomoxetine in a child or adolescent must balance this risk with the clinical need.
• Patients who are started on therapy should be monitored closely for suicidality (suicidal thinking and behavior), clinical worsening, or unusual changes in behavior.
• Families and caregivers should be advised of the need for close observation and communication with the prescriber.