Biaxin and Pregnancy

Biaxin (clarithromycin) is a pregnancy Category C medicine, which means it may not be safe to use during pregnancy. Biaxin was shown to increase the risk of heart defects and cleft palate, as well as decreased fetal growth, when given to pregnant animals. Although it has not been studied in any pregnant women, a healthcare provider may prescribe Biaxin to pregnant women if the benefits outweigh the risks.

Is Biaxin Safe During Pregnancy?

Biaxin® (clarithromycin) is a prescription antibiotic. At this time, it is not clear if Biaxin is safe for use during pregnancy. The manufacturer recommends that pregnant women take the drug only if there are no other acceptable alternative antibiotics available to treat the infection.
 

Biaxin and 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 that 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 "default" Category C rating.
 
When large doses of Biaxin were given to pregnant rats, the medication slightly increased the risk of heart defects. When given to pregnant monkeys, Biaxin caused decreased fetal growth. When given to pregnant mice, it increased the risk of cleft palate. Biaxin has not been adequately studied in any pregnant women.
 
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. If other, more suitable antibiotics are available (and are likely to be effective for treating a particular infection), Biaxin should be avoided. However, if the medication appears to be necessary to treat an infection, the benefits may outweigh the potential risks.
 
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