When human data are lacking.(Drugs, Pregnancy, And Lactation)

Family Practice News | September 1, 2008| | Copyright

In 2007, the Food and Drug Administration approved 16 new molecular entities and several new biologics. None of these agents have human pregnancy experience, but some will be prescribed to women of reproductive age and exposure in early gestation is inevitable.

There also are situations when a woman's condition requires drug therapy, regardless of pregnancy. New antineoplastics are indicated when other therapies have failed to fit into this category, such as ixabepilone (Ixempra) and lapatinib (Tykerb), for breast cancer; nilotinib (Tasigna), for leukemia; and ...

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