Although the FDA panel also discussed adding side effects including depression, hallucinations and thoughts of suicide, the FDA decided not to include these events in the labeling of said ADHD medications.
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The two new side effects that will be included in the box label for Focalin and Focalin XR are angioedema, a swelling of the skin, and anaphylaxis, an allergic reaction that may result in fatality. As of present, the FDA has not included any neuropsychiatric symptoms on the new drug labels, although the FDA did agree to continue monitoring the adverse effects of such drugs.
"Members raised concerns that many of the neuropsychiatric symptoms were not included in the label — such as hallucinations, depression, suicidal ideation — and some members thought they should be considered for inclusion in the label," says Sandy Walsh, spokeswoman for the FDA.
Perhaps one of the reasons the FDA didn’t include these events was because it wants to make labeling uniform across this class of ADHD medications.
The last time ADHD medication labels were reviewed was back in 2006 when the FDA decided not to update the labels on ADHD medications.