Department of General Psychiatry, Royal United Hospital, Bath BAI 3NG, UK
Hendrick et al (2001) state that the findings of their study provide no reason to discourage nursing among women taking paroxetine, fluvoxamine or sertraline at standard therapeutic doses. Comparison with previous studies is difficult, owing to the research literature consisting mainly of single case reports or small samples, difference in methods and lack of key information (as reviewed by Yoshida et al, 1999).
While I applaud the effort of studying 50 nursing motherinfant pairs, I disagree with the inclusion of all of them as study subjects for two main reasons.
First, seven were included whose prescribed doses of antidepressant were below the recommended dose (British Medical Association & Royal Pharmaceutical Society of Great Britain, 2001) for the treatment of depression (paroxetine 5 mg (n=1), paroxetine 10 mg (n=2), sertraline 25 mg (n=4)). In the case of sertraline, where 30 pairs were included, exclusion of these subjects would increase the percentage of detection of medication, including metabolites, from 24% (8/30) to 34% (8/26).
Second, Hendrick et al came to the same conclusion regarding the safety of fluvoxamine, sertraline and paroxetine, but according to their Table 1 (p. 164) only one serum sample of the five taken from motherinfant pairs where the mother was taking fluvoxamine should be taken into consideration. Of the remainder, no maternal medication concentration was obtained in three cases, and in the fourth maternal medication concentration was below the detectable range of the assays, raising questions about compliance that will add bias to the results.
REFERENCES
British Medical Association & Royal Pharmaceutical Society of Great Britain (2001) British National Formulary (March issue). London & Wallingford: BMJ Books & Pharmaceutical Press.
Hendrick, V., Fukuchi, A., Altshuler, L., et al
(2001) Use of sertraline, paroxetine and fluvoxamine by
nursing women. British Journal of Psychiatry,
179,
163-166.
Yoshida, K., Smith, B. & Kumar, R. C. (1999) Psychotropic drugs in mothers' milk: a comprehensive review of assay methods, pharmacokinetics and of safety of breast-feeding. Journal of Psychopharmacology, 13, 64-80.[Medline]
Department of Psychiatry & Biobehavioral Sciences, UCLA, 300 Medical Plaza, Los Angeles, CA 90024-6968, USA
Research grants: SmithKline Beecham; consultation: Forrest, Novartis; speakers' bureaux: Pfizer, Forrest, Novartis, SmithKline Beecham, Bristol-Myers.
Dr Agell rightly points out that seven of the nursing women in our study were taking paroxetine and sertraline at doses lower than are usually recommended for the treatment of major depression. We disagree, however, with his conclusion that these motherinfant pairs were not valid subjects for the study. These women are representative of many new mothers who choose to take the lowest dosage of medication that will benefit them for the duration of their nursing. Further, we considered the range of subjects' doses in our correlation analyses of the relationship between maternal dosage of anti-depressant and infant serum concentration of medication. In fact, one of the primary goals of our study was to identify the dosage of medication that was likely to produce a detectable level of medication in the infants.
Dr Agell also points out that fluvoxamine cannot be deemed safe in the same manner as paroxetine and sertraline, given the smaller number of fluvoxamine exposures. We agree with this observation and recommend that, whenever possible, nursing women be prescribed antidepressants for which the most extensive safety data are available.
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