The gout drug Uloric may lead to serious heart-related complications, and the FDA is warning patients and medical professionals of the danger of Uloric side effects. If you or a loved one suffered a heart-related issue and use Uloric, you may have a legal claim.

Gout is type of arthritis in which uric acid builds up in a joint. This may cause redness, pain, and swelling. Drugs like Uloric help to treat gout by lowering the amount of uric acid in the blood. However, the drug’s negative side effects may outweigh its benefits for many patients.

On Nov. 15, the U.S. Food and Drug Administration (FDA) warned that Uloric may be connected to death from heart complications and adverse events. The FDA stated that this connection was noted in a recent study comparing gout drugs conducted by the drug’s maker, Takeda.

The study specifically compared the performance and side effects of Uloric to another gout drug, allopurinol. Allopurinol is also sold under the name brands Zyloprim and Aloprim.

According to the study, patients taking Uloric were more likely to die from heart-related issues than patients taking allopurinol. The study also found that Uloric patients had a higher mortality rate from all causes than patients taking allopurinol.

Uloric was approved by the FDA in 209 based on initial clinical trials. The initial clinical trials indicated that there was a high risk of heart attacks, strokes, and heart-related deaths associated with Uloric. Because of these risk, the federal government required the drug’s maker, Takeda, to perform another study on the drug’s risks.

So, in 2009, gout patients were able to take Uloric while the government and the medical community were still waiting on further information, possibly putting their health at risk .

Now, the additional study has been released, indicating an increase in risk in heart attacks, strokes, and heart-related deaths. These risk are not included in the warning label of the drug.

Based on this information, the FDA warned that “health care professionals should consider this safety information when deciding whether to prescribe or continue patients on febuxostat (Uloric). Patients should talk to your health care professionals if you have any questions or concerns. Do not stop taking your medicine without first consulting with your health care professional.”

Nonetheless, Medscape notes that the FDA still recommends Uloric for some gout patients, despite the risk of Uloric side effects. But BioSpace reports that a consumer group is pushing back on this move, pressuring the FDA to pull the drug from the market. 

The Takeda study was not the first time that serious concern was raised over Uloric’s health risks. In 2012, a former Takeda safety consultant filed a whistleblower lawsuit claiming that the drugmaker hid information about Uloric side effects and those of other drugs from the FDA.

According to the former safety consultant, Takeda failed to alert the FDA that Uloric could be fatal when combined with certain other medication. The whistleblower even claimed that Takeda’s failure to report this led to the death of some Uloric patients.

The whistleblower also claimed that Takeda misrepresented some of Uloric’s side effects as less severe than they actually were, including bone marrow failure, severe bleeding and kidney failure.