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In 1997, ondansetron was the subject of a meta-analysis case study. Researchers examined 84 trials, with 11,980 people receiving ondansetron, published between 1991 and September 1996. Intravenous ondansetron 4 mg versus placebo was investigated in 16 reports and three further reports which had been duplicated a total of six times.
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Iron deficiency anemia in pregnancy can lead to an increased risk of premature delivery, low birth weight and increased risk of perinatal mortality. [ 64 ] The Recommended Dietary Allowance (RDA) suggests 27 mg of iron a day which would account for normal iron losses, iron used by the fetus and related tissues during gestation and increased ...
The pregnancy category of a medication is an assessment of the risk of fetal injury due to the pharmaceutical, if it is used as directed by the mother during pregnancy. It does not include any risks conferred by pharmaceutical agents or their metabolites in breast milk. Every drug has specific information listed in its product literature.
Risk Evaluation and Mitigation Strategies (REMS) is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for serious adverse effects. REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs. [1] The REMS program was formalized in 2007.
A high-risk pregnancy is a pregnancy where the mother or the fetus has an increased risk of adverse outcomes compared to uncomplicated pregnancies. No concrete guidelines currently exist for distinguishing “high-risk” pregnancies from “low-risk” pregnancies; however, there are certain studied conditions that have been shown to put the mother or fetus at a higher risk of poor outcomes. [1]
A health risk assessment (HRA) is a health questionnaire, used to provide individuals with an evaluation of their health risks and quality of life. [5] Commonly a HRA incorporates three key elements – an extended questionnaire, a risk calculation or score, and some form of feedback, i.e. face-to-face with a health advisor or an automatic online report.