The U.S. Food and Drug Administration (FDA) issued a heavy warning about gout medication, Uloric, in January 2019. The black box warning that was issued is the strictest labeling requirement that the FDA can mandate on prescription medication and highlights the high risk of adverse drug reactions. It warns patients that the side effects may outweigh any benefits associated with taking the medication. Uloric has been linked to an increased chance of cardiovascular issues and even death. Patients who have suffered adverse effects after taking this drug will be searching for a drug injury law firm that can help them file a lawsuit against the manufacturers of Uloric.
Uloric, also called Febuxostat, is a medication that doctors prescribe to treat gout, a condition where needle-like crystals of uric acid form in a person’s joints, causing inflammation and pain. The drug is prescribed by physicians to reduce the amount of acid, thereby reducing inflammation and other symptoms of gout.
Patients who have taken Uloric and suffered injuries and families of patients who have died as a result of Uloric are filing lawsuits against Takeda Pharmaceuticals. The lawsuits allege that the pharmaceutical company failed to warn patients and doctors of dangerous side effects such as heart attacks and kidney failure.
Patients who have suffered Uloric injuries will want to file a drug injury lawsuit against the responsible parties. These Uloric lawsuit leads need help to claim compensation for their injuries, the cost of medical treatment, lost wages, and pain and suffering. There are specific elements that every plaintiff must prove in order to win a Uloric lawsuit.
In some drug injury cases, it is not necessary for the plaintiff to prove that the manufacturer was negligent. To win in other types of personal injury cases, however, the plaintiff is required to show that the defendant was negligent. Based on strict liability, the manufacturer is held responsible when harm is caused due to a dangerous drug. Whether Takeda Pharmaceuticals did or did not know that Uloric would harm patients does not matter. The company is responsible for harm that its product caused to the people who used the medication.
Uloric lawsuits are in the early stages of litigation. Due to a large number of patients who took Uloric before the black box warning was added, there are potentially thousands of lawsuits.
The FDA approved Uloric with the requirement that Takeda Pharmaceuticals conduct a postmarket clinical safety trial to test the safety of the drug.
The FDA held a joint meeting with the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss the safety of Uloric.
The FDA issued a black box warning for Uloric to warn patients about the increased risk of cardiovascular death with this drug compared to alternatives.
FDA. “FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat)“, U.S. Department of Health and Human Services. Accessed March 8, 2019.
WebMD. “Uloric Side Effects by Likelihood and Severity“, WebMD. Accessed March 18, 2019.
Megan Brooks. “FDA Warns of Higher Risk for Death With Gout Drug Febuxostat (Uloric)“, Medscape. Accessed February 23, 2019.
Angus Liu. “FDA pressured to revoke Takeda’s popular gout drug Uloric due to death concerns“, Fierce Pharma. Accessed June 22, 2018.