
Pregnancy is a delicate time, and medical treatments require extra caution. Studies show that physiological changes during pregnancy can significantly impact how drugs are metabolized, potentially leading to adverse effects on both the mother and the baby. Health agencies like the CDC highlight the importance of understanding drug safety during pregnancy.
Orencia (abatacept) is a biologic medication commonly prescribed to treat autoimmune diseases like rheumatoid arthritis and psoriatic arthritis. While highly effective, its use during pregnancy requires careful consideration due to potential impacts on the developing baby and the immune system.
In this article, we will explore the considerations for using Orencia during pregnancy, including risks, benefits, and guidance for expectant mothers.
Key Takeaways
- Orencia is classified as FDA Category C, indicating potential fetal risks based on animal studies, but human studies are limited.
- Effective management of autoimmune conditions during pregnancy is essential, as some conditions may worsen without treatment, affecting both the mother and baby.
- Using Orencia during pregnancy may be justified in certain cases, especially when disease flare-ups pose greater risks than continuing treatment.
- Open communication between healthcare providers and patients is critical to ensure informed decision-making, discussing both the benefits and risks of Orencia.
- Consulting multiple healthcare providers, such as obstetricians and rheumatologists, ensures a comprehensive treatment plan tailored to the patient’s needs.
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FDA Category C Classification for Orencia
The FDA classifies Orencia as a Category C medication, indicating that animal studies have shown potential fetal risks, such as reduced fetal weight and skeletal malformations. However, due to limited controlled studies in humans, its safety during pregnancy remains uncertain.
For pregnant patients, healthcare providers must carefully weigh Orencia’s potential benefits against its associated risks. An individualized approach to decision-making is essential to ensure the best possible outcomes while prioritizing the safety of both the mother and the developing baby.
Risks vs. Benefits: Managing Autoimmune Conditions During Pregnancy

Managing autoimmune diseases during pregnancy is particularly challenging, as each condition behaves differently. For instance, rheumatoid arthritis (RA) may improve, remain stable, or worsen during pregnancy, while conditions like ankylosing spondylitis (AS) and systemic lupus erythematosus (SLE) often show no improvement and may deteriorate. Effective disease management is vital to minimizing risks for both the mother and baby.
Research suggests that maintaining stable disease control for at least six months before conception leads to safer pregnancies. This period of stability reduces complications and improves outcomes for both the mother and the developing baby.
Guidance on Using Orencia During Pregnancy

Several studies, including one that analyzed data from over 200 pregnancies, found no consistent pattern of birth defects associated with abatacept use during pregnancy. While this data provides valuable insights for healthcare providers to weigh the risks and benefits of treatments like Orencia, it is essential to use this medication only when absolutely necessary. Limited research exists regarding its impact on preterm births or birth weight, which underscores the need for careful consideration.
Doctors should inform patients that discontinuing Orencia could lead to a flare-up of disease symptoms, potentially causing greater harm to both the mother and baby than continuing treatment. It is important to note that Orencia can remain in the body for approximately 10 weeks after stopping.
If a patient’s autoimmune condition worsens without treatment, continuing Orencia may be the safest and most effective option for managing symptoms and protecting both the mother and baby. Maintaining disease control with proper Orencia dosing helps minimize risks and ensures a safer pregnancy outcome for both the mother and the developing baby.
Discussion with Patients: Managing Expectations
Open communication about risks is essential when considering Orencia during pregnancy. Doctors should clearly explain the potential dangers and benefits, helping patients make informed decisions about their treatment. This transparent discussion fosters trust and ensures patients fully understand their options.
Healthcare providers must also address the possible effects of Orencia on the baby, both short- and long-term. Trust and collaboration between doctors and patients are key to making decisions that prioritize safety and effectiveness.
Pregnant women should consult multiple specialists, such as obstetricians and rheumatologists, to gain a comprehensive understanding of their condition and treatment options. Collaborative decision-making supported by research-based facts empowers patients to feel confident in their choices, ensuring the best outcomes for both mother and baby.
Conclusion
Orencia is a valuable treatment option for managing autoimmune diseases, but its use during pregnancy requires careful consideration. With its FDA Category C classification, the risks and benefits must be thoroughly evaluated on a case-by-case basis. While studies have shown no consistent pattern of birth defects linked to abatacept, the limited research highlights the need for caution.
Effective disease management is essential to ensuring the safety of both the mother and baby. Open communication between healthcare providers and patients, coupled with a collaborative approach to treatment planning, helps achieve the best outcomes. By prioritizing informed decision-making and individualized care, Orencia can remain a potential option for pregnant patients who require autoimmune disease management.
FAQs
1. Can Orencia be used safely during pregnancy?
Orencia is classified as an FDA Category C medication, meaning its safety during pregnancy is uncertain. Its use should be carefully considered, weighing the potential benefits against the risks.
2. What does FDA Category C mean for Orencia?
FDA Category C indicates that animal studies have shown potential fetal risks, but there are no well-controlled studies in pregnant women. Orencia should only be used when the potential benefits outweigh the risks.
3. Can Orencia affect preterm births or birth weight?
Limited research exists regarding Orencia’s impact on preterm births or birth weight, so its use requires careful consideration and close monitoring.
4. What happens if Orencia is discontinued during pregnancy?
Discontinuing Orencia during pregnancy may lead to a flare-up of autoimmune disease symptoms, potentially posing more significant risks to the mother and baby than continuing treatment.
References
Medicine and Pregnancy: An Overview. U.S. Centers for Disease Control and Prevention. Published May 15, 2024. https://www.cdc.gov/medicine-and-pregnancy/about/index.html
Pinheiro EA, Stika CS. Drugs in pregnancy: Pharmacologic and physiologic changes that affect clinical care. Seminars in Perinatology. 2020;44(3):151221. doi:10.1016/j.semperi.2020.151221
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