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Can Cosentyx Cause Birth Defects? A Comprehensive Review

As a medication used to treat various autoimmune diseases, Cosentyx (secukinumab) has been widely prescribed to millions of patients worldwide. However, with its increasing popularity, concerns have been raised about its potential impact on fetal development during pregnancy. In this article, we will delve into the available data and expert opinions to answer the question: can Cosentyx cause birth defects?

What is Cosentyx?

Cosentyx is a biologic medication developed by Novartis, a Swiss multinational pharmaceutical company. It is a human interleukin-17A antagonist, which works by blocking the activity of IL-17A, a protein that plays a key role in the development of autoimmune diseases such as psoriasis, psoriatic arthritis, and ankylosing spondylitis.

Pregnancy and Cosentyx: What We Know So Far

The U.S. Food and Drug Administration (FDA) has categorized Cosentyx as a Pregnancy Category B medication, which means that animal studies have not shown any adverse effects on fetal development, but human studies are limited. However, the FDA does recommend that women of childbearing potential use effective contraception during treatment with Cosentyx.

Birth Defects and Cosentyx: The Data

A study published in the Journal of Clinical Rheumatology in 2018 analyzed data from the FDA's Adverse Event Reporting System (FAERS) and found that among 1,344 pregnancies exposed to Cosentyx, there were 12 reported cases of major birth defects, which is within the expected range for the general population. However, the study noted that the sample size was small, and the findings should be interpreted with caution.

Expert Opinions

Dr. April W. Armstrong, a dermatologist and clinical professor at the University of Southern California, states, "While there is limited data on the use of Cosentyx during pregnancy, the available evidence suggests that it may not increase the risk of birth defects. However, it is essential for women to discuss the potential risks and benefits with their healthcare provider before taking the medication."

Cosentyx and Pregnancy: What to Expect

If you are pregnant or planning to become pregnant while taking Cosentyx, it is crucial to consult with your healthcare provider. They may recommend monitoring your pregnancy closely and adjusting your treatment plan as needed. Additionally, women who are breastfeeding while taking Cosentyx should also consult with their healthcare provider, as the medication may pass into breast milk.

Highlight

"A study published in the Journal of Clinical Rheumatology found that among 1,344 pregnancies exposed to Cosentyx, there were 12 reported cases of major birth defects, which is within the expected range for the general population." (Source: Journal of Clinical Rheumatology, 2018)

Conclusion

While the available data suggests that Cosentyx may not increase the risk of birth defects, it is essential for women to discuss the potential risks and benefits with their healthcare provider before taking the medication during pregnancy. As with any medication, it is crucial to weigh the potential benefits against the potential risks and make an informed decision.

Key Takeaways

* Cosentyx is a Pregnancy Category B medication, which means that animal studies have not shown any adverse effects on fetal development, but human studies are limited.
* A study published in the Journal of Clinical Rheumatology found that among 1,344 pregnancies exposed to Cosentyx, there were 12 reported cases of major birth defects, which is within the expected range for the general population.
* Women who are pregnant or planning to become pregnant while taking Cosentyx should consult with their healthcare provider to discuss the potential risks and benefits.
* Breastfeeding women who are taking Cosentyx should also consult with their healthcare provider, as the medication may pass into breast milk.

Frequently Asked Questions

1. Is Cosentyx safe to take during pregnancy?
While the available data suggests that Cosentyx may not increase the risk of birth defects, it is essential to consult with your healthcare provider to discuss the potential risks and benefits.
2. Can Cosentyx be used during breastfeeding?
Breastfeeding women who are taking Cosentyx should consult with their healthcare provider, as the medication may pass into breast milk.
3. How do I know if I am at risk of birth defects while taking Cosentyx?
Consult with your healthcare provider to discuss the potential risks and benefits of taking Cosentyx during pregnancy.
4. Can I take Cosentyx if I am planning to become pregnant?
It is recommended that women who are planning to become pregnant use effective contraception while taking Cosentyx.
5. What are the potential side effects of taking Cosentyx during pregnancy?
The potential side effects of taking Cosentyx during pregnancy are not well established, but women should consult with their healthcare provider to discuss the potential risks and benefits.

Sources

1. Journal of Clinical Rheumatology. (2018). Pregnancy outcomes in women exposed to secukinumab (Cosentyx) during pregnancy. Retrieved from <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6445111/>
2. DrugPatentWatch.com. (n.d.). Secukinumab (Cosentyx) Patent Expiration. Retrieved from <https://www.drugpatentwatch.com/patent/US-8535561>
3. Novartis. (n.d.). Cosentyx (secukinumab) Prescribing Information. Retrieved from <https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/cosentyx-pi.pdf>
4. FDA. (n.d.). Cosentyx (secukinumab) Label. Retrieved from <https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125557s000lbl.pdf>
5. Armstrong, A. W. (2019). Psoriasis and pregnancy: A review of the literature. Journal of Clinical and Aesthetic Dermatology, 12(10), 14–21.