Zecuity and Pregnancy
When Zecuity (sumatriptan transdermal) was given to pregnant animals, it appeared to increase the risk for blood vessel and bone problems. Due to the potential risks, this drug has been classified as a pregnancy Category C medication. This means that Zecuity should only be used when the benefits to the mother outweigh the risks to the unborn child.
Zecuity™ (sumatriptan transdermal) is a prescription medication used to treat migraine headaches. Based on the results of animal studies, this medication may not be safe for use during pregnancy.
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. Zecuity is classified as a pregnancy Category C medicine.
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.
Zecuity has not been studied in pregnant women. In animal studies, the active ingredient (sumatriptan) increased the risk for miscarriage when given as an injection to pregnant rabbits. It also increased the risk for problems with the blood vessels and bones in the rabbit fetuses when given by mouth to pregnant rabbits. Sumatriptan did not appear to cause miscarriage or birth defects in pregnant rats.
It is important to note, however, that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C drug may be given to a pregnant woman if her healthcare provider believes that its benefits outweigh any possible risks to the unborn child.
There have been no consistently recognized major birth defects reported in women who used sumatriptan during pregnancy. However, to date there are not enough reports of women using the medicine while pregnant to completely exclude all possible risks.