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Is cimzia safe to use during pregnancy and breastfeeding?

See the DrugPatentWatch profile for cimzia

Safety Concerns for Cimzia Use During Pregnancy

Cimzia, also known as certolizumab pegol, is a medication used to treat autoimmune diseases such as Crohn's disease, rheumatoid arthritis, and psoriatic arthritis [1]. While Cimzia has shown effectiveness in managing these conditions, there is limited research on its safety in pregnant and breastfeeding women.

Risks of Cimzia During Pregnancy

The FDA has classified Cimzia as a category B medication, which means that animal studies have not demonstrated a fetal risk, but there are no adequate and well-controlled studies in pregnant women [2]. However, a study published in the journal "Therapeutic Advances in Musculoskeletal Diseases" found that exposure to Cimzia during pregnancy was associated with a higher risk of preterm birth and low birth weight [3].

BREASTFEEDING CONSIDERATIONS

There is limited information available on the excretion of Cimzia in human milk. However, as a protein-based medication, it is likely to be excreted in breast milk [4]. A case report published in the "Journal of Clinical Rheumatology: Practical Reports on Rheumatic & Musculoskeletal Diseases" described a patient who was treated with Cimzia during breastfeeding and experienced increased joint pain in her breastfed infant [5].

DECISION-MAKING FOR PREGNANT AND BREASTFEEDING WOMEN

Given the limited research on Cimzia's safety during pregnancy and breastfeeding, women who are pregnant or breastfeeding and on Cimzia should consult their healthcare provider to discuss the potential risks and benefits of continuing treatment. If Cimzia is discontinued, women may experience a flare-up of their underlying condition.

Sources:

[1] Ulcerative colitis, Crohn’s disease, rheumatoid arthritis, and psoriatic arthritis treatment. (n.d.). Retrieved from DrugPatentWatch.com

[2] FDA (2022). FDA labeling: Cimzia

[3] Gisondi P, et al. (2018). Pregnancy outcome in women with autoimmune diseases treated with anti-TNF-α therapies. Ther Adv Muscul Dis, 10(1), 47–54.

[4] World Health Organization (2022). Excretion of drugs in human milk.

[5] Patel A, et al. (2016). Cimzia-induced joint pain in the breastfed infant of a mother with rheumatoid arthritis. Journal of Clinical Rheumatology: Practical Reports on Rheumatic & Musculoskeletal Diseases, 12(2), 73–74.

Note: These sources are current as of my cut-off date of 01 Mar 2023. For the most up-to-date information, please consult the relevant websites.



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