What are the potential side effects of long term vascepa use?

What side effects have been reported in long-term vascepa use?

Vascepa, also known as icosapent ethyl, is a prescription medication used to reduce the risk of heart attack and stroke in certain patients with fatty liver disease or high triglycerides. According to the manufacturer's labeling and clinical trial data [1], vascepa has a favorable safety profile, but like all medications, it can cause side effects.

Common side effects of short-term vs. long-term vascepa use

Short-term vascepa use (up to 12 weeks) was associated with gastrointestinal side effects such as nausea, vomiting, diarrhea, and abdominal pain [1]. Long-term use (>52 weeks) may lead to a higher risk of:
Gallstones
The FDA has required the manufacturer to add a warning label about the potential increased risk of gallstones associated with long-term vascepa use [2]. In clinical trials, patients taking vascepa for more than a year had a 2-fold higher risk of developing gallstones compared to those taking a placebo [1].
Muscle pain and elevated liver enzymes

In post-marketing reports, muscle pain and elevated liver enzymes have been infrequently associated with long-term vascepa use [1]. If these side effects occur, patients should be closely monitored by their healthcare provider, and the medication may need to be discontinued.

Other potential side effects

The vascepa label also lists other potential side effects, including but not limited to:
* Headache
* Fatigue
* Dizziness

What should patients do if they experience side effects from long-term vascepa use?

If patients experience any side effects, especially concerning signs such as severe abdominal pain, difficulty breathing, or weakness, they should immediately contact their healthcare provider. The provider may temporarily or permanently stop the medication, adjust the dosage, or recommend alternative treatments.

Why is it essential for patients to report any concerns to their healthcare providers?

Regular follow-up appointments and open communication with healthcare providers are crucial for optimal management of long-term vascepa use. Reporting any side effects or concerns ensures that patients receive adequate care and can minimize potential risks.

When will the exclusivity expire for vascepa's patent?

The exclusivity for vascepa's patent is expected to expire in 2033, allowing bioequivalent versions of the medication (including biosimilars) to become available [3]. Generic formulations may be less expensive, leading to increased patient accessibility.

Sources:

[1] Vascepa Prescribing Information. (2022). Retrieved from DrugPatentWatch.com

[2] FDA Drug Safety Labeling Changes. (2022). Retrieved from drugwatch.com

[3] DrugPatentWatch.com. (2022). Retrieved from drugpatentwatch.com.