Uloric is prescribed for the treatment of gout, a type of arthritis afflicting more than 8 million Americans. The cause is elevated uric acid levels in the blood, which can be due to impaired kidney function, genetic factors, and/or diet. It is most common in those who primarily eat too much fatty meat, consume large amounts of alcohol, and/or are obese (historians suggest that Henry VIII of England had suffered from the condition, and it has been known since ancient times as “the disease of kings”). When uric acid levels are too high, it forms crystals, which are then deposited in the joints and tendons, causing periodic flareups.
Uloric works by disabling the action of an enzyme that converts certain purines into uric acid. In addition to an elevated risk of heart attack, side effects of Uloric include:
- arthralgia (joint pain)
- elevated liver enzymes
- liver failure
- skin rash
There have also been indications that Uloric can have psychological effects as well. A full list of known and suspected Uloric side effects can be found at Uloric Side Effects.
The FDA issued its initial safety alert in November 2017 after the preliminary results of post-market safety studies confirmed the dangers of cardiovascular events in patients taking Uloric compared to those treated with allopurinol. After that, Takeda was ordered to perform additional studies in order to determine the exact nature of risks. Ultimately, the results showed an increased risk of fatal heart attacks and stroke.
Over the past few years, a growing number of injury lawsuits have been filed by people who have been affected by Uloric, claiming that drug maker Takeda was aware of the dangerous side effects and deliberately withheld this information from patients and the medical community. These allegations were at the center of a whistleblower lawsuit filed by a former Takeda employee in 2010. Although that lawsuit was dismissed in 2012, the relator in the case, Dr. Helen Ge, has been attempting to revive the complaint.