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Centre for Evidence-
Based Medicine

Harm: Clinical Scenario

A 28 year old female patient of yours has a recurrent unipolar depressive illness that is well maintained on sertraline therapy. She is thinking about having children, but is concerned about the risks of harm becoming pregnant while taking fluoxetine. She wants to know what the risks are.

You ask the clinical question: "in patients taking sertraline therapy what is the likelihood of an adverse outcome to pregancy?"

You search MEDLINE using PubMed and the filter for aetiology studies and selecting a sensitive search with the terms "selective serotonin reuptake inhibitors" and "pregnancy". Of the 9 hits, one looks useful ( JAMA 279 (8):609-610, 1998. ) so you download the full text version from the Ovid full text web service.

Read the article and decide:

  1. Are the results of this harm study valid?
  2. Are the results of this harm study important?
  3. Should these valid, important results of this study about a potentially harmful treatment change the treatment of your patient?

Continue to completed worksheet