Sirturo and Pregnancy
It is probably safe to take Sirturo (bedaquiline) during pregnancy, as animal studies showed that this drug did not appear to cause problems when given to pregnant rats and rabbits. However, because animals do not always respond to medications in the same way as humans, talk to your healthcare provider about whether it is safe to take this medication when pregnant.
Sirturo™ (bedaquiline) is a prescription antibiotic used in the treatment of tuberculosis. Based on animal studies, this medication is probably safe for use during pregnancy.
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. Sirturo is classified as a pregnancy Category B medicine.
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.
Sirturo has not been studied in pregnant women. In animal studies, the drug did not cause birth defects or other problems when given to pregnant rats and rabbits.
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 B medicine should be given to a pregnant woman only if her healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child.
If you become pregnant or are thinking about becoming pregnant while taking Sirturo, let your healthcare provider know. He or she will consider the benefits and risks before making a recommendation in your particular situation.