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Starlix and Pregnancy

Based on the results of animal studies on Starlix and pregnancy, the FDA has classified it as a pregnancy Category C medication. When high doses were given to pregnant rats, it caused gallbladder problems in the baby rats. However, animals do not always respond to medications in the same way as humans. Therefore, if you are taking Starlix and pregnancy occurs, your healthcare provider will weigh the benefits and risks before making a recommendation.

Starlix and Pregnancy: An Overview

Starlix® (nateglinide) may not be safe for women to take during pregnancy. This is based on animal studies that looked at the effects of the drug on pregnancy.

Starlix and Pregnancy Category C

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 C is given to medicines that have not been studied in pregnant humans but that do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Starlix was given a pregnancy Category C rating based on the results of animal studies. When the drug was given to pregnant rats at very high doses, it caused gallbladder problems in the baby rats.
It is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if the healthcare provider believes that the benefits to the mother outweigh any possible risks to the unborn child.

Starlix and Pregnancy: Recommendations

If you are pregnant or thinking about becoming pregnant while taking Starlix, let your healthcare provider know. He or she will consider the benefits and the risks of taking the drug during pregnancy before making a recommendation for your particular situation.
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