The extended release chewable drug is therapeutically equivalent to Adderall XR – which is identical to meth – and its side effects include loss of appetite, insomnia, abdominal pain, emotional lability, vomiting, nervousness, nausea, and fever. When the FDA deemed the central nervous system (CNS) stimulant safe in January, it warned:
1. CNS stimulants, including ADZENYS XR-ODT, other amphetamine-containing products, and methylphenidate, have a high potential for abuse and dependence.
2. CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.
3. CNS stimulants may induce a mixed or manic episode in patients with bipolar disorder.
4. CNS stimulants, at recommended doses, may cause psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania in patients without prior history of psychotic illness or mania.
5. CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients.
6. Sudden death has been reported in association with CNS stimulant treatment at recommended doses in pediatric patients with structural cardiac abnormalities or other serious heart problems.
7. Stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon.