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On December 17, 2004, the FDA required a warning be added to atomoxetine because of reports that two patients (an adult and child) developed severe liver disease (both patients recovered). In the clinical trials of 6,000 patients, no evidence of hepatotoxicity was found. Patients who develop jaundice, dark urine, or other symptoms of hepatic disease should discontinue atomoxetine. Routine monitoring of hepatic function is not required during atomoxetine treatment.
Patients treated with medication for ADHD should have their height and weight monitored throughout treatment. If the patient has a change in height or weight that crosses 2 percentile lines, this suggests an aberrant growth trajectory. In these cases, a drug holiday should be considered, if return of symptoms during weekends or summers does not lead to marked impairment of functioning. The clinician should also consider switching the patient to another ADHD medication. It is important for the clinician to carefully balance the benefits of medication treatment with the risks of small reductions in height gain, which as of yet have not shown to be related to reductions in adult height.
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