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Neonates exposed to fluoxetine and other SSRIs or serotonin and norepinephrine reuptake inhibitorsSNRIslate in the third trimester have developed complications requiring prolonged hospitalizationrespiratory supportand tube feedingSuch complications can arise immediately upon deliveryReported clinical findings have included respiratory distresscyanosisapneaseizurestemperature instabilityfeeding difficultyvomitinghypoglycemiahypotoniahypertoniahyperreflexiatremorjitterinessirritabilityand constant cryingThese features are consistent with either a direct toxic effect of SSRIs and SNRIs orpossiblya drug discontinuation syndromeIt should be noted thatin some casesthe clinical picture is consistent with serotonin syndromesee WARNINGS AND PRECAUTIONS

Patients should be advised of the following issues and asked to alert their healthcare provider if these occur while taking SARAFEM.

Healthcare providers should instruct their patients to read the Medication Guide before starting therapy with SARAFEM and to reread it each time the prescription is renewed.

Anaphylactoid reactionsincluding bronchospasmangioedemalaryngospasmand urticaria alone and in combinationhave been reported.

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