There have been a number of gout medicine side effects associated with the medical prescription drug, Uloric. Many people have reportedly suffered heart-related complications while taking Uloric.

According to the U.S. Food and Drug Administration (FDA), a warning was issued based on a recent study that found that Uloric was linked to an increase in heart-related deaths. In the study, Uloric was compared to another gout drug, allopurinol, sold under brand names Aloprim and Zyloprim.

In addition to heart-related deaths found linked to Uloric, other gout medicine side effects included deaths from all other causes as well. Gout medicine side effects linked to Uloric can include non-deadly strokes, non-deadly heart attacks, and cardiac ischemia necessitating immediate surgery.

Overview: Gout Medicine Side Effects

Two drug safety communications were issued by the FDA on Nov. 15. One safety communication suggested that the FDA would be further investigating the findings of increased heart-related deaths being linked to Uloric. The second safety communication also affirmed that it would be looking into Uloric’s side effects of increased risks of death from all other causes.

According to the FDA’s statement, “The preliminary results show that overall, febuxostat did not increase the risk of these combined events compared to allopurinol. However, when the outcomes were evaluated separately, febuxostat showed an increased risk of heart-related deaths and death from all causes.”

The FDA’s announcement came after the drug’s manufacturer released results of the clinical trial. These results noted that Uloric, in comparison to allopurinol, caused increased risk of fatal heart-related events.

The clinical trial, however, included more than 6,000 gout patients. The trial was later published in the New England Journal of Medicine.

The FDA first approved Uloric in 2009. The initial clinical trial found there to be increases of gout medicine side effects such as strokes, heart attacks, and heart-related deaths. These side effects were noted on the warning label of the drug and because of these risks the FDA mandated the drug’s manufacturer to perform an additional study after the drug’s release on the market.

The FDA warned that “Health care professionals should consider this safety information when deciding whether to prescribe or continue patients on febuxostat. 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 professionals,” they stated.

Gout Medicine Side Effects Whistleblower Lawsuit

Due to serious gout medicine side effects, a former Takeda safety consultant filed a whistleblower lawsuit in 2012. Among other allegations, the lawsuit accused the drug’s manufacturer of failing to disclose pertinent information related to the drug’s adverse side effects and complications from the federal government.

The lawsuit specifically claimed the company failed to reveal Uloric’s serious adverse side effects when combined with other medications such as imuran, methadone, warfarin, and digoxin. The whistleblower also accused the company of making Uloric side effects seem not as severe by altering and misrepresenting documents sent over to the FDA.