Sumavel and Pregnancy

When large doses of Sumavel (sumatriptan injection) were given to pregnant rabbits in animal studies, the medication appeared to increase the risk of miscarriages, bone abnormalities, and other problems. The FDA considers Sumavel a pregnancy Category C medication, so it may not be safe for women who are expecting. However, it may still be prescribed when the benefits outweigh the risks.

Can Pregnant Women Take Sumavel?

Sumavel™ DosePro™ (sumatriptan injection) is a prescription medication approved to treat migraine headaches and cluster headaches. Based on the results of animal studies, this drug may not be safe for use during pregnancy, although the full risks are currently unknown.

What Is 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 do appear to cause harm to the fetus in animal studies.
In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Sumavel was given a pregnancy Category C rating based on studies in pregnant animals. For example, giving sumatriptan (the active ingredient in Sumavel) to pregnant rabbits appeared to increase the risk of miscarriages and other problems, such as blood vessel and bone abnormalities. These risks were not seen when sumatriptan was tested on rats.
However, it is important to note that animals do not always respond to medicines in 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.
In general, reports of use of sumatriptan in pregnant women do not suggest that the medication is likely to cause problems, although such reports cannot rule out the possibility of rare problems.
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Sumavel Medication Information

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