Sular and Pregnancy
In clinical studies, Sular increased miscarriages and birth defects when it was given to pregnant rabbits, rats, and monkeys. It also caused weight loss in both the mother and newborn. If you are taking Sular and pregnancy occurs, your healthcare provider will weigh the benefits and risks before making a recommendation for your situation.
For people who are pregnant, Sular® (nisoldipine) may not be safe. This is based on animal studies that looked at the effects of Sular during pregnancy.
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 C is given to medicines that have not been studied in pregnant humans but 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.
Sular was given a pregnancy Category C rating because of potential problems in animal studies. When given to pregnant rabbits, rats, and monkeys, Sular caused increased miscarriages and birth defects. Sular also caused decreased weight of both the mother and offspring.
However, it is important to note that animals do not always respond to medicines 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 pregnant woman outweigh any possible risks to the unborn child.
If you are pregnant or thinking of becoming pregnant while taking Sular, let your healthcare provider know. He or she will consider both the benefits and risks of Sular during pregnancy before making a recommendation for your particular situation.