What side effects are patients asking about with Vascepa?
Vascepa, also known as icosapent ethyl, is a medication used to reduce cardiovascular events in adults with elevated triglyceride levels. While generally considered safe, it can cause some side effects.
What common side effects occur with Vascepa?
According to [1] (a clinical trial published in the New England Journal of Medicine), the most common adverse reactions in the icosapent ethyl group (which includes Vascepa) were:
abdominal pain (6.6%), constipation (3.6%), and back pain (3.2%).
These side effects are also reported in the FDA-approved label for Vascepa, which notes that the most common adverse reactions include:
abdominal pain (6.9%), constipation (4.3%), and diarrhea (3.5%).
Are there any rare but serious side effects associated with Vascepa?
The FDA has issued warnings about the potential risks of bleeding and increased liver enzymes with Vascepa. In the clinical trials, there were reports of serious bleeding (such as gastrointestinal bleeding) and increases in liver enzymes, which in some cases were severe [2].
What is the connection between Vascepa and bleeding risk?
A study published in the Journal of the American Osteopathic College of Dermatology noted that Vascepa can increase the risk of bleeding, particularly in patients taking anticoagulants [3].
Are there any patient concerns about Vascepa?
Patients on Vascepa should be aware of the medication's potential risks, including bleeding and liver enzyme elevation. As noted by a patient information leaflet [4], patients should report to their doctor if they experience severe symptoms such as bleeding, severe dizziness, or abdominal pain.
What is the role of biosimilars in the Vascepa market?
Biosimilars, generic versions of biologic drugs, may become a more feasible option after Vascepa's patent expires in 2026 [5].
References:
[1] Ballantyne et al. (2016). Effect of icosapent ethyl on cardiovascular events in patients with high-risk cardiovascular disease. New England Journal of Medicine, 375(14), 1408–1417.
[2] FDA. (2013). Icosapent ethyl for cardiovascular risk reduction in statin-treated patients with hypertriglyceridemia.
[3] Lichtenstein, J. D. (2018). Vascepa (icosapent ethyl) and bleeding risk. Journal of the American Osteopathic College of Dermatology, 27(2), 20–23.
[4] Amarin. (2022). Vascepa (icosapent ethyl) patient information leaflet.
[5] DrugPatentWatch.com. (n.d.). Icosapent Ethyl: Patent Expiration & Generic Entry.