Warnings & Precautions

6 Warnings & Precautions

6.1 Warnings

All patient medication doses should be monitored by a physician while taking Hardy Nutritionals® Daily Essential Nutrients (DEN). Research indicates that psychoactive drugs may need to be gradually reduced or eliminated during nutrient therapy to avoid over-medication effects, with the recognition that abrupt medication discontinuation can be associated with adverse symptoms (see 5.2 Drug interactions and 2.3 Potentiation of psychiatric medications).

6.2 Precautions

6.2.1 Citrus bioflavonoids

Patients who are currently taking a citrus bioflavonoid-containing supplement and are currently taking or have recently taken psychoactive medication(s) should reduce the dose of citrus bioflavonoids gradually during DEN therapy in order to minimize medication withdrawal effects resulting from reductions in CYP enzymemediated drug potentiation caused by citrus bioflavonoids.

6.2.2 Clinical worsening

Patients being treated for any indication should be monitored closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of therapy and at times of dose changes (either increases or decreases) in DEN or medications. Patients and/or caregivers should promptly report any adverse symptoms to a health professional, as medication dose changes may be required (see 8.1 Psychiatric medication, 2.3 Potentiation of psychiatric medications, and 2.4 Clinical response – CNS drug use).

6.2.3 Iron

Although DEN contains a relatively low level of iron (about 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/kg (27.2 mg of iron/lb) of body weight.