Is sertraline safe in breast feeding?

One of my colleagues and I had a PUN/DEN moment today. A PUN is a Patient Unmet Need while a DEN is a Doctor’s Educational Need. This are rather fancy abbreviations for questions that come to us in daily clinical practice. A quick discussion with colleagues or a search on websites will bring a resolution to the problem in most cases. These questions if compiled somewhere are a good source of directed learning and education.

The answer to our question was not quite as clear as we initially expected. According to Epocrates online it is safe in lactation. According to rxlist.comIt is not known whether, and if so in what amount, sertraline or its metabolites are excreted in human milk“. And finally to confuse matters according to drugs.comSertraline passes into breast milk. Side effects have been reported in a baby exposed during nursing. Before taking this medicine, make sure your doctor knows if you are nursing your baby.” For a final clinically weightted answer rather than an ‘avoid being sued legal answer’ we went to emedicine.com which said the following:

  • Women who plan to breastfeed must be informed that all psychotropic medications, including antidepressants, are secreted into breast milk. Concentrations in breast milk vary widely.
  • Data on the use of tricyclic antidepressants, fluoxetine, sertraline, and paroxetine during breastfeeding are encouraging, and serum antidepressant levels in the breastfed infant are either low or undetectable. Reports of toxicity in breastfed infants are rare, although the long-term effects of exposure to trace amounts of medication are not known.
  • We discussed the case and it transpired the mother had only fed her child once as she was afraid of the package insert. We felt it was in the patiet’s best interests and her child’s that she continue breast feeding and consider the likelihood of any adverse outcome due to the sertraline as very low.

    Dyspepsia and meals – linked?

    Came across what sounded like an interesting article from the title Functional Dyspepsia Usually Worsened by Meal Intake it is reviewed by Medscape as part of their CME series for doctors (link). The study tried to work out the time course of symptoms post-meal and came up with the conclusion that there is a temporal link between meals and symptoms. The symptoms occurred in the following order about 15 minutes after the meal fullness, bloating, nausea, belching and lastly epigastric pain. Functional dyspepsia is striclty speaking an endocsopic diagnosis where there is no underlying pathology noted on endoscopy to account for findings.

    At first glance this study seems a bit inane. But it provides valuable corroboration for an intuitive conclsuion that most family doctors have i.e. there is a link between dyspepsia and meals. This might seem like an obviously true statement but as illustrated by the NICE guidelines on dyspepsia the evidence linking lifestyle measures and types of meals to dyspepsia is contradictory at best and non-existant at worse. This study provides evidence of causality of symptoms to meals. It confirms my own observations on the relationship between meals, types of meals and functional dyspepsia.

    Breast self-examination – help or harm?

    An updated Cochrane plain language summary (Nov 4, 2008) on self examination in breast cancer notes the following:

    • Self-examination did not result in lower mortality.
    • Self-examining were more than twice as likely to have a biopsy than those who did not.
    • Comparing patient self-exam v clinical exam – the best study was abandoned due to poor compliance.
    • A nuanced concludion by the authors: Breast awareness (of any changes) may have resulted in lower breast cancer mortality in some countries.

    I don’t recommend self or clinical examination as a screening procedure as there is no good evidence in two very large trials. To me breast aware rather than breast beware sounds like a more balanced approach to breast disease.

    Should I take Vitamin C or E?

    The Physicians Health Study II has reported in the Journal of the American Medical Association the effect of taking Vitamin C and E as supplements to prevent CVD after an eight year follow up using a RCT trial design. It won’t be a surprise to many physicians to find out that it had absolutely no effect on these outcome measures and on the other hand it did throw up a concerning result. The concerning result was the increased incidence of haemorrhagic strokes for those taking Vitamin E. Though total mortality outcomes are equivalent in Vitamin C or E v placebo groups there was hazard ratio of 1.74 for haemorrhagic stroke for Vitamin E v placebo with a p value of 0.04 (significant).

    I don’t recommend vitamin C or E for my patients for the purpose of primary prevention and / or general purpose well being – and would put patients off taking Vitamin E in particular without any compelling reason.