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Altabax and Pregnancy

In animal studies on pregnancy and Altabax (retapamulin), the drug did not appear to increase the risk of serious problems. Therefore, the FDA has classified it as a pregnancy Category B medication. However, animals do not always respond to medicines in the same way as humans, so talk to your healthcare provider about any possible risks that may apply to you.

Can Pregnant Women Use Altabax?

Altabax® (retapamulin) is a prescription skin antibiotic approved for the treatment of impetigo. Based on information from animal studies, this drug appears to be safe for use during pregnancy, although the full risks to humans 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.
In addition, medications that have been shown to be safe for use in pregnancy in humans but have caused problems in laboratory animals are given a Category B rating.
In general, animal studies do not show that Altabax increases the risk of birth defects or other serious problems. Some problems, such as miscarriages and low fetal weights, were seen at extremely high doses; however, this was due to toxicity in the mother, not direct toxicity to the fetus. Similar problems are not expected to be seen with normal use in humans.
It is important to note that animals do not always respond to medicines in 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.
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