Abstract
In both phase III studies of LUM/IVA, as well as an extension study, worsening of mental health was not reported as a common side effect. Here we describe five cases in adolescent female patients that suggest a worsening of anxiety or depression associated with its use. In these five patients, two experienced suicidal ideation and three made suicide attempts that resulted in psychiatric hospitalizations.
Keywords:
CFTR modulator; Cystic fibrosis.
Copyright © 2017 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.
MeSH terms
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Adolescent
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Aminophenols* / administration & dosage
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Aminophenols* / adverse effects
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Aminopyridines* / administration & dosage
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Aminopyridines* / adverse effects
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Antidepressive Agents / administration & dosage*
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Anxiety* / chemically induced
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Anxiety* / diagnosis
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Anxiety* / drug therapy
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Benzodioxoles* / administration & dosage
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Benzodioxoles* / adverse effects
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Child
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Cognitive Behavioral Therapy / methods*
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Cystic Fibrosis* / drug therapy
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Cystic Fibrosis* / psychology
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Depression* / chemically induced
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Depression* / diagnosis
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Depression* / drug therapy
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Drug Combinations
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Female
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Humans
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Membrane Transport Modulators / administration & dosage
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Membrane Transport Modulators / adverse effects
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Quinolones* / administration & dosage
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Quinolones* / adverse effects
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Suicidal Ideation
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Suicide, Attempted / prevention & control*
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Withholding Treatment
Substances
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Aminophenols
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Aminopyridines
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Antidepressive Agents
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Benzodioxoles
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Drug Combinations
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Membrane Transport Modulators
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Quinolones
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lumacaftor, ivacaftor drug combination