Actemra and Pregnancy
When Actemra (tocilizumab) was given to pregnant monkeys during animal studies, the medication increased the risk of miscarriages. As a result, the FDA considers the drug a pregnancy Category C medication, meaning it may not be safe for women who are expecting. However, it may still be prescribed if the benefits outweigh the risks.
Is Using Actemra During Pregnancy Safe?Actemra® (tocilizumab) is a prescription medication approved to treat rheumatoid arthritis and idiopathic juvenile arthritis. Although this medication has not been studied in pregnant women, animal studies have suggested that Actemra may pose some risk to a fetus. Keep in mind, however, that the full risks are currently unknown.
What Is 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.
When given to pregnant monkeys, Actemra increased the risk of miscarriages. It did not increase the risk of birth defects.
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 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 you take Actemra while you are expecting, you may choose to have your healthcare provider register you with the manufacturer so that your information (and the outcome of your pregnancy) may be used to help study the effects of this medication during pregnancy.