5.2.2 Clinical worsening
Patients being treated for any indication should be observed closely by families and caregivers for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of therapy, or at times of DEN or medication dose changes (either increases or decreases). Such symptoms should be reported to the patient's prescriber or health professional, as medication dose changes may be required (see 8.1 Psychiatric medication management
Although DEN contains a relatively low level of iron (less than 1 mg per capsule), children should take DEN only under adult supervision. In cases documented by US Poison Control Centers, children who have died from iron supplements have taken more than 60 mg of iron/kilogram (27.2 mg of iron/pound) of body weight.