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Tykerb and pregnancy is a potentially dangerous combination. In clinical studies, up to 91 percent of newborn rats that were exposed to the medication during pregnancy died within four days after birth. As a result, Tykerb should only be taken if the benefits outweigh the risks to the unborn child. If you are taking Tykerb and pregnancy occurs, notify your healthcare provider immediately.
Tykerb® (lapatinib) is generally not considered safe for women who are pregnant. In animal studies that looked at the effects of Tykerb during pregnancy, the drug increased the risk of death in the newborn animals.
The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category D is given to medicines that have shown clear evidence of risk to the fetus in studies. Pregnancy Category D is a stronger warning than a pregnancy Category C classification. However, a pregnancy Category D medicine may still be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh the risks to the unborn child.
Tykerb was given a pregnancy Category D rating because of problems in animal studies. Up to 91 percent of the newborn rats that were exposed to the medicine during pregnancy died within the first four days after birth. In addition, Tykerb is approved only for use in combination with Xeloda® (capecitabine) or Femara® (letrozole). Xeloda is a pregnancy Category D medication (see Xeloda and Pregnancy). Femara is a pregnancy Category X medication (see Femara and Pregnancy).