Arthritis Home > Simponi and Pregnancy

When large doses of Simponi (golimumab) were given to pregnant monkeys in clinical studies, no problems were seen in the offspring. The FDA considers Simponi a pregnancy Category B medication, so it is generally considered safe for women who are expecting. However, it still should only be prescribed when the benefits outweigh the risks.

I'm Pregnant -- Is It Safe to Use Simponi?

Simponi™ (golimumab) is a prescription medication approved to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and ankylosing spondylitis. Based on the results of animal studies, Simponi appears to be safe for use during pregnancy, although the full risks 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.
Studies have shown that giving even very large doses of Simponi to pregnant monkeys did not cause any problems for the offspring.
However, it is important to note that animals do not always respond to medicines 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.

Simponi and Pregnancy: Final Thoughts

If you are pregnant or thinking about becoming pregnant, let your healthcare provider know. Your healthcare provider will consider both the benefits and risks of using Simponi during pregnancy before making a recommendation in your particular situation.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
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