Spiriva and Pregnancy

Animal studies on Spiriva and pregnancy show that the medication may pose a risk to the fetus. In pregnant rats and rabbits, Spiriva increased the risk of miscarriages and caused low birth weight, among other things. However, since animals and humans can respond to drugs differently, if you are taking Spiriva and pregnancy occurs, your healthcare provider may have you continue taking it if the benefits outweigh the risks.

Spiriva HandiHaler --Drug Information

Is Spiriva Safe During Pregnancy?

Spiriva^® (tiotropium bromide) is a prescription medication used to treat chronic obstructive pulmonary disease (COPD). It may not be safe for women who are pregnant. In animal studies that looked at the effects of Spiriva during pregnancy, the drug caused miscarriages and other problems.

Spiriva 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 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.

Spiriva was given a pregnancy Category C rating because of problems seen in animal studies. When given to pregnant rats, the drug increased the risk of miscarriages, low birth weight, and delayed sexual maturation in the offspring. When given to pregnant rabbits, it increased the risk of miscarriages.

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 woman outweigh any possible risks to the unborn child. Because medications like Spiriva can be essential for people with asthma, healthcare providers often recommend that women continue to take the drug during pregnancy.

(Spiriva and Pregnancy Continued: Page 2)