Avandia During Pregnancy -- What Are the Risks?
In September 2010, the U.S. Food and Drug Administration (FDA) announced that it would be severely restricting the use of Avandia, due to the risk of "cardiovascular events" such as heart attacks and strokes. Only individuals who cannot control their diabetes on other medications (or those who are already taking the medication and doing well) will be able to take Avandia.
Avandia and Pregnancy Category C
The U.
S. Food and Drug Administration (FDA) uses a pregnancy 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. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Avandia was given a pregnancy Category C rating based on studies in pregnant animals. When given to pregnant rabbits and rats in mid-to-late pregnancy, Avandia caused miscarriages and decreased growth of the baby rabbits and rats. Avandia did not cause any problems when given to rats or rabbits early in pregnancy.
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.
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