Savaysa (edoxaban) is an oral anti-clotting drug that was approved by the FDA in January 2015 for the prevention of stroke and non-central-nervous-system systemic embolism in patients with non-valvular atrial fibrillation. Atrial fibrillation is a medical condition characterized by irregular and an often rapid heartbeat. As a result, this condition commonly causes poor blood flow in the body, leading to the formation of blood clots. It also increases the risk of stroke.

Unlike Xarelto, Savaysa contains explicit warning from the outset that it may cause “serious and potentially fatal bleeding.” Unfortunately, there is no treatment that is proven to reverse this adverse effect of using Savaysa. Other listed side effects include anemia (low red blood cell count), rash, abnormal liver function tests.

Another serious risk from using Savaysa occurs when use of the drug is prematurely discontinued. According to a press release from the drug’s manufacturer, “premature discontinuation of the drug increases the risk of ischemic events.” Ischemia is a disease characterized by an interruption in the blood flowing through the arteries to a tissue, organs, or an extremity (such as the arms, hands, legs, or feet). If left untreated it can damage body tissue, organs, and lead to death. For this reason, it is suggested that discontinuation of Savaysa is substituted with another anti-clotting drug.

In addition, Savaysa is not recommended for patients with a history of bleeding (pathological bleeding) given the potentially fatal bleeding that could occur; and patients with mechanical heart valves, or moderate to severe mitral stenosis (a disorder where the heart’s mitral valve does not open causing a restriction of blood flow) due to the lack of trial research concerning the drug’s interaction in patients with these conditions. Others who have increased risks of injury are nursing mothers (it is recommended to discontinue using the drug or discontinue nursing), patients with impaired renal function (impaired ability of the kidneys to filter waste from the body), and patients with a hepatic impairment (impaired liver function).

While Savaysa has been recently approved by the FDA and will arrive on the market with an apparently adequate amount of warnings, potential litigation may arise where doctors prescribe the use of Savaysa without taking into account a patient’s individual medical history or failing to provide adequate warnings of the potential side effects.

If you use Savaysa and suffer any of the serious side effects discussed here, you may be entitled to compensation for your injuries. The attorneys associated with Jacoby & Meyers can help you get the assistance you need in evaluating your case.

Please contact our defective drug lawyers today to schedule your free initial consultation. Jacoby & Meyers has offices nationwide.

Zachary Mayberry, student intern Jacoby & Meyers.