Nilandron and Pregnancy
It is not known whether it is safe for pregnant women to take Nilandron (nilutamide). Nilandron is only approved for use in men with metastatic prostate cancer who have undergone surgical castration -- this medication is not approved for any use in women. Because it hasn't been studied in women, the potential risks to a developing fetus are unknown.
Can Pregnant Women Take Nilandron?Nilandron® (nilutamide) is a prescription medication approved to treat prostate cancer that has spread beyond the prostate (known medically as metastatic prostate cancer). It is used in men who have had surgery to remove their testicles (surgical castration). This medication may not be safe for use during pregnancy, although the full risks are currently unknown.
What Is Pregnancy Category C?Nilandron is classified as a pregnancy Category C drug. 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 adequately studied in pregnant humans but have caused fetal harm in animal studies.
In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Nilandron has not been studied in pregnant animals or pregnant women. Therefore, it is automatically considered a pregnancy Category C medication.
Pregnancy Category C medications should only be given to pregnant women if the potential benefits outweigh any possible risk to the fetus. Nilandron is not approved for use in women, including pregnant women. Therefore, there are very few (if any) situations in which the medication would be justifiable for use during pregnancy.