Exubera and Pregnancy
Although there have been no studies on Exubera and pregnancy, the FDA has classified it as a pregnancy Category C medication, meaning it may not be safe to take while pregnant. However, when the same type of insulin is administered by injection, it is classified as a pregnancy Category B medicine (meaning it is most likely safe to take when pregnant). If you are taking Exubera and pregnancy occurs, your healthcare provider will consider the benefits and risks in your particular situation.
In October 2007, Pfizer announced it will stop making Exubera. This decision was voluntary and was not based on any safety concern; Pfizer states that Exubera has not met its expectations in terms of sales. Starting in October 2007, Exubera will be available for an additional three months, which will give people enough time to change from Exubera to another type of insulin or other diabetes medication.
It is not known if Exubera® (inhaled insulin) is safe for women to take while pregnant, since it has not been studied in pregnant women or animals.
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 appeared to cause harm to the fetus in animal studies. Also, medicines that have not been studied in pregnant women or animals are automatically given a pregnancy Category C rating.
Exubera was given a pregnancy Category C rating because it has not been studied in pregnant women or animals. However, it is important to note that when the same type of insulin is administered by injection, it is classified as a pregnancy Category B medicine (meaning that it is most likely safe to take during pregnancy). In fact, insulin is the treatment of choice for pregnant women with diabetes.
Although the full risks of using Exubera in pregnancy are not known, 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.