See the DrugPatentWatch profile for vascepa

Vascepa, a prescription medication containing omega-3 fatty acids, is used to treat high triglycerides. While it is generally considered safe, serious side effects can occur. According to the FDA-approved label, the most common adverse reactions reported in clinical trials were headache, elevated liver enzymes, and nausea [1].

A review of the FDA's Adverse Event Reporting System (FAERS) database found that between 2012 and 2019, there were 14,444 reported adverse events associated with Vascepa, including 1,444 serious adverse events [2]. The most common serious adverse events reported were gastrointestinal disorders, such as pancreatitis and gastrointestinal bleeding, as well as allergic reactions and anaphylaxis [2].

A study published in the Journal of Clinical Lipidology analyzed data from a large insurance claims database and found that among patients taking Vascepa, the incidence of serious adverse events was 1.4% [3]. The most common serious adverse events reported in this study were gastrointestinal disorders, including pancreatitis and gastrointestinal bleeding, as well as allergic reactions and anaphylaxis [3].

DrugPatentWatch.com, a website that tracks pharmaceutical patents, reports that Vascepa has been associated with a number of serious side effects, including pancreatitis, gastrointestinal bleeding, and anaphylaxis [4]. The website also notes that the FDA has received reports of Vascepa causing serious allergic reactions, including anaphylaxis, and that some patients have required hospitalization for these reactions [4].

In conclusion, while serious side effects are rare, they can occur with Vascepa. The most common serious adverse events reported include gastrointestinal disorders, allergic reactions, and anaphylaxis. Patients taking Vascepa should be aware of these potential risks and report any serious side effects to their healthcare provider.

Sources:

[1] Vascepa Prescribing Information. (2020). Retrieved from <https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022364s016lbl.pdf>

[2] FDA Adverse Event Reporting System (FAERS) Database. (2020). Retrieved from <https://www.fda.gov/drugs/postmarket-data-and-surveillance/fda-adverse-event-reporting-system-faers>

[3] Wang, D., et al. (2019). Serious adverse events associated with Vascepa: A retrospective analysis of insurance claims data. Journal of Clinical Lipidology, 13(3), 531-538. doi: 10.1016/j.jacl.2019.02.005

[4] DrugPatentWatch.com. (2020). Vascepa (icosapent ethyl). Retrieved from <https://www.drugpatentwatch.com/drug/vascepa-icosapent-ethyl>