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Data evaluating the risk of major congenital malformations and oral clefts with topiramate (a component of Qsymia) exposure during pregnancy is available from the North American Anti-Epileptic Drug (NAAED) Pregnancy Registry and from several larger retrospective epidemiologic studies. The NAAED Pregnancy Registry suggested an estimated increase in risk for oral clefts of (95% CI - ). Larger retrospective epidemiology studies showed that topiramate monotherapy exposure in pregnancy is associated with an approximately two to five-fold increased risk of oral clefts (Table 5). The FORTRESS study, sponsored by the maker of Qsymia, found an excess risk of (95% CI = - to ) oral cleft cases per 1,000 infants exposed to topiramate during the first trimester.

Clinical practice guidelines recommend > 3400 anti-factor Xa International Units of LMWH subcutaneous daily (equivalent to > 34 mg subcutaneous daily of enoxaparin). For most patients, continue prophylaxis until hospital discharge; however, in patients that are considered to be at high risk (., > 60 years of age or a history of VTE), continue prophylaxis through hospitalization and for 2—4 weeks after discharge. Previous guidelines have suggested a dose of enoxaparin 40 mg subcutaneous 1—2 hours before surgery then daily or 30 mg subcutaneous every 12 hours starting 8—12 hours before surgery.

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