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Pharmaceutical agents have become an essential tool in the medical armamentarium. Pharmaceutical companies over the past century not only have developed more consistently effective agents that are used to manage acute-onset conditions, but also have improved the quality of life of those suffering from chronic progressive disease. The use of any medication must be tempered by its potential side effects. Thus, the clinician must assess the benefit-risk ratio between therapeutic efficacy and safety risks before resorting to any therapeutic intervention in any patient. The benefit-risk assessment (BRA) is made on the weight of randomized evidence obtained from formal clinical trials and observations collected from pharmacovigilance activities after the drug is put on the market . In obstetric practice, the benefit-risk ratio assessment for a pharmaceutical agent must further consider the specific benefit-risk ratio assessment relevant to the developing fetus. The fetal risk assessment presented by a particular agent may not be immediately possible since adverse effects may not be specific and easily linked to the agent, or may present themselves later on in life.