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Abstract

The objective of this pilot study was to examine the relation between fluvoxamine (FVX) plasma concentrations, therapeutic response and side effects during a four-week treatment period. Twenty-two patients who met the DSM-IV criteria for major depression received 100 mg FVX during the first 2 days of treatment and then 150 or 200 mg/day. No clear relationship between plasma concentrations and side effects was detectable. A relationship between plasma concentrations and clinical efficacy was detectable after 21 days but not after 28 days of treatment. These preliminary results indicate that therapeutic drug monitoring might be useful for patients treated with FVX.

Serum Concentration–Dose Relationship and Modulation Factors in Children and Adolescents Treated with Fluvoxamine

“…No serious adverse effects were documented in any of the patients of this study monitored by TDM. In accordance with the present results, no clear correlation between fluvoxamine serum concentrations and the occurrence or severity of adverse events has been reported in the literature [ 26 , 28 ].…”

“…In nearly half of the patients, a suitable therapeutic response to fluvoxamine treatment was reported. Findings on a relationship between serum concentrations and response to fluvoxamine in adults and minors are heterogeneous [ 10 , 11 , 12 , 25 , 26 , 27 , 38 , 39 , 40 ]; in the present sample, no such correlation was observed. ADRs were documented in more than a third of the children and adolescents, a result that is consistent with the work of Biener et al in minors (35% [ 11 , 12 ]) as well as with studies in adults (42–50% [ 41 , 42 ]).…”

“…Labellarte and colleagues [ 10 ], however, reported nonlinearity in a smaller sample of 16 children and 18 adolescents treated with fluvoxamine. Studies in adult patients showed conflicting results, too [ 24 , 25 , 26 , 27 , 28 ]. The result of nonlinearity in smaller studies might be modulated by CYP2D6 gene variants, which were not considered in any study and can remarkably affect plasma exposure to fluvoxamine [ 29 , 30 , 31 , 32 ].…”

“…TDM of patients taking fluvoxamine is recommended for personalized pharmacotherapy, both for dose titration and special indications, such as the assessment of medication adherence. For adult patients with depression, the TRR has been defined as 60–230 ng/mL based on studies with (flexible) fluvoxamine doses between 200 and 300 mg/d [ 25 ], 150 and 200 mg [ 26 ], and 25 and 200 mg/d [ 8 , 43 ]. A comparison of the present data with the TRR for adults with depression revealed that about half (51.4%) of all measured fluvoxamine concentrations were within the TRR for adults with depression, and almost one-third (31.4%) were above the TRR for adults.…”