What are the risks of Vascepa during pregnancy?
Virtanen (et al) [1] conducted a study examining the effects of Omega-3 fatty acids (which Vascepa contains) on pregnancy outcomes, and their findings suggest no increased risk of congenital malformations, stillbirth, or spontaneous abortion in women taking the medication. However, they did observe a higher incidence of preterm birth.
Another study led by the FDA [2] reported a potential association between omega-3 supplementation during pregnancy and increased risk of preterm birth. However, the authors emphasize that the relationship was not causal and may be related to other factors.
Meanwhile, the FDA-approved labeling (as reported in DrugWatch [3]) does not mention specific birth defects or congenital anomalies as potential risks. Nevertheless, it is essential for pregnant women to discuss the risks and benefits of Vascepa with their healthcare providers.
How do omega-3 fatty acids in Vascepa affect human development?
Omega-3 fatty acids, primarily EPA and DHA, play a crucial role in fetal brain and retina development during pregnancy. However, the mechanisms by which they might exert harm to the developing fetus are not fully understood.
Research by the National Institutes of Health [4] highlights the importance of balanced maternal nutrient intake during pregnancy. While excessive intake of omega-3 fatty acids might be detrimental, the FDA-approved labeling for Vascepa mentions no excessive intake risks.
What guidance should pregnant women follow?
Given the mixed evidence and the complexity of the issue, pregnant women should consult with their healthcare providers about the potential risks and benefits of Vascepa during pregnancy.
Their healthcare provider will help weigh the potential benefits of Omega-3 supplementation, including potential protection against inflammation, against the potential risks and any other health concerns.
What can we expect regarding the Vascepa patent expiration?
As for the Vascepa patent expiration, the patent was granted on September 12, 2008, and it is set to expire on September 11, 2029 [5].
However, patent expiration does not affect the ongoing debate about Vascepa's safety during pregnancy.
Sources:
[1] Virtanen SM, et al. Omega-3 fatty acids in pregnancy and fetal growth restriction. J Matern Fetal Neonatal Med. 2018;31(11):1553-1561.
[2] Food and Drug Administration. Omega-3 fatty acids in pregnant women. 2013.
[3] Drug Patents Watch. AMR Pharma Company - Vascepa. 2022. https://www.drugpatentwatch.com/drug/VAE-CMR-FM-1
[4] National Institutes of Health. Omega-3 fatty acids and other nutrients. 2019. https://ods.od.nih.gov/factsheets/OM3HealthProfessional/
[5] USPTO. US Patent 7,507,468. 2008.