Alsuma and Pregnancy
When the active ingredient in Alsuma was given to pregnant rabbits, it appeared to increase the risk for complications like miscarriages and bone abnormalities. Due to the potential risks, the FDA classified Alsuma as a pregnancy Category C drug, meaning it may not be safe for use in pregnant women and should only be used if the benefits outweigh the risks.
Can Pregnant Women Use Alsuma?Alsuma™ (sumatriptan) is a prescription medication approved to treat migraine headaches and cluster headaches. Based on the results of animal studies, Alsuma may not be safe for use during pregnancy, although the full risks are currently unknown.
Triptan medications, including Alsuma, are usually not the first choice for migraine treatment in pregnant women. Other, safer options like acetaminophen or nonmedication alternatives are usually preferred, although these options are not always helpful.
What Is Pregnancy Category C?
Alsuma is classified as a pregnancy Category C drug. 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 adequately studied in pregnant humans but have caused fetal harm 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.
Alsuma was given a pregnancy Category C rating based on studies in pregnant animals. For example, giving sumatriptan (the active ingredient in Alsuma) to pregnant rabbits appeared to increase the risk for miscarriages, abnormalities of the bones and blood vessels, and other problems. These risks were not seen when sumatriptan was tested on pregnant 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 her unborn child.
In general, reports of sumatriptan use in pregnant women do not suggest that the medication is likely to cause problems; however, these reports cannot rule out the possibility of rare problems.