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Patients should be advised to take SARAFEM exactly as prescribedand to continue taking SARAFEM as prescribed even after their symptoms improvePatients should be advised that they should not alter their dosing regimenor stop taking SARAFEM without consulting their physiciansee WARNINGS AND PRECAUTIONSPatients should be advised to consult with their healthcare provider if their symptoms do not improve with SARAFEM.
Drugs That Interfere With Hemostasisfor exampleNSAIDSAspirinWarfarin)
There are no adequate and well-controlled clinical studies on the use of fluoxetine in pregnant womenResults of a number of published epidemiological studies assessing the risk of fluoxetine exposure during the first trimester of pregnancy have demonstrated inconsistent resultsMore than 10 cohort studies and case-control studies failed to demonstrate an increased risk for congenital malformations overallHoweverone prospective cohort study conducted by the European Network of Teratology Information Services reported an increased risk of cardiovascular malformations in infants born to womenN253exposed to fluoxetine during the first trimester of pregnancy compared to infants of womenN1359who were not exposed to fluoxetineThere was no specific pattern of cardiovascular malformationsOverallhowevera causal relationship has not been established.
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