As a pregnancy Category B medication, Fragmin (dalteparin) is generally considered safe for women who are expecting. Animal studies indicate that even high doses of this medication do not increase the risk of birth defects. Also, the drug does not cross the placenta, so it is not expected to cause problems for a developing fetus.
Is It Safe for Pregnant Women to Use Fragmin?
Fragmin® (dalteparin sodium) is a prescription medication approved to treat and prevent blood clots in certain situations (and also to prevent certain complications after heart attacks or other similar "cardiac events"). It is generally thought to be safe for use during pregnancy.
What Is Pregnancy Category B?
The U.S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category B is given to medicines that have not been adequately studied in pregnant humans, but do not appear to cause harm to the fetus in animal studies. Medications that have been shown to be safe for use in pregnancy in humans (but have caused problems in laboratory animals) are also given a Category B rating.
Fragmin is thought to be safe for use during pregnancy for several reasons. In animal studies, the drug did not increase the risk of birth defects, even at high dosages. Also, Fragmin does not cross the placenta (to the developing fetus) in humans, so it is not expected to increase the risk of bleeding in the fetus. Lastly, small studies that looked at using Fragmin in pregnant women generally indicated that the drug does not appear to cause any significant problems (other than the usual risks with Fragmin that may apply to any individual).
Pregnant women cannot take warfarin (Coumadin®, Jantoven®), the oral anticoagulant, as it can cause serious problems (see Coumadin and Pregnancy). Therefore, heparin or low-molecular-weight heparin medications (like Fragmin) are preferred during pregnancy. In most cases, Fragmin is thought to be as safe and effective as using regular heparin during pregnancy.
It should be noted that pregnant women probably should not take Fragmin from a multi-dose vial, as this product contains benzyl alcohol as a preservative. Benzyl alcohol crosses the placenta and can cause serious problems in premature newborns. The more commonly used single-dose prefilled syringes do not contain benzyl alcohol.
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