InnoPran XL and Pregnancy
In animal studies, InnoPran XL (propranolol XL) increased the risk of miscarriages and newborn death when it was given in high doses to pregnant rats. Since little human research has been done, however, the full risks of using this drug while pregnant are not known. If pregnancy occurs while you are taking InnoPran XL, notify your healthcare provider immediately.
InnoPran XL® (propranolol XL) is a prescription medicine approved to treat high blood pressure. Based on the results of animal studies, InnoPran XL may not be safe for use in pregnant women.
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.
When given to pregnant rats during pregnancy and while breastfeeding, high doses of propranolol (the active ingredient in InnoPran XL) increased the risk of miscarriages or newborn death. In rabbits, no similar problems were seen.
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 a healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child.
Little human research has been done on the effects of InnoPran XL on the fetus. There have been individual reports of slowed intrauterine growth, small placentas, and birth defects related to propranolol usage during pregnancy. There have also been reports of a very low heart rate, low blood sugars, and/or decreased breathing in some newborns whose mothers took beta blockers just before or during childbirth.