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Effient and Pregnancy

The FDA classifies Effient as a pregnancy Category B medication, which means it appears to be safe for use during pregnancy. However, the full risks are still unknown, so it's important to discuss your particular situation with your doctor. If you have recently had a heart attack and must take Effient, your doctor may recommend that you not try to get pregnant while taking it.

Is Effient Safe During Pregnancy?

Effient® (prasugrel hydrochloride) is a prescription antiplatelet medication. It is usually used to prevent problems such as heart attacks and strokes in people who have had an angioplasty procedure. Based on the results of animal studies, it appears to be safe for use during pregnancy, although the full risks are currently unknown.
 

What Is Pregnancy Category B?

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 B is given to medicines that have not been adequately studied in pregnant humans but do not appear to cause harm to the fetus in animal studies.
 
Medications that have been shown to be safe for use in pregnancy in humans but have caused problems in laboratory animals are also given a Category B rating.
 
In studies, giving very high doses of Effient (30 times the equivalent dosage in humans) to pregnant rats and rabbits did not increase the risk of miscarriages, birth defects, or other problems. When the doses were increased high enough to cause toxicity in the mothers, a slight decrease in newborn weight was noticed, but this could be due to the toxicity in the mothers, not any direct effect on the fetus.
 
However, it is important to note that animals do not always respond to medicines the same way that humans do. Therefore, a pregnancy Category B medicine should be given to a pregnant woman only if the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.
 
Effient can be a life-saving drug, and is used in serious situations, such as after a heart attack. The benefits to the mother likely outweigh the risks to the fetus in most situations. However, Effient should be taken with aspirin, which should generally be avoided during pregnancy, except in low doses in certain situations.
 
In addition, women who must take Effient may be advised to avoid pregnancy for other reasons -- particularly if they have recently had a heart attack. All of these issues should be discussed with your healthcare provider.
 
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Effient Medication Information

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