FDA Includes Black Box Warning on Gout Medicine Uloric

As of February 2019, the U.S. Food and Drug Administration has stated that there is a higher risk of death associated with gout medicine Uloric (febuxostat) compared to other gout medicines. The FDA has now included a Black Box Warning for Uloric as a result of the recent findings. Here, the pharmaceutical liability attorneys at The Law Offices of Peter Angelos detail the risks of Uloric as well as your legal rights if you or a loved one experiences complications as a result of taking Uloric.

 Uloric was Approved as a Treatment for Gout

Uloric, also called febuxostat, is a medication that was approved in 2009 to treat gout, a form of arthritis. Gout is a chronic disease that occurs in patients as a result of uric acid buildup that leads to severe swelling and pain in the joints. The condition impacts over eight million individuals in the United States. Uloric works to lower the amount of uric acid in the body and provide relief for patients suffering from gout.

FDA Evaluates the Link Between Uloric and Heart-Related Death in 2017

In November 2017, the FDA began to evaluate the link between Uloric and death, specifically death associated with the heart. After extensive evaluation, the FDA concluded that there is a higher risk of heart-related death associated with Uloric compared to other types of gout medication such as allopurinol. The FDA came to this conclusion after a review of the results of a clinical trial that found a higher risk of heart-related death, as well as death from all causes, with Uloric.

The FDA Adds A Black Box Warning to Uloric

As a result of the safety clinical trial, the FDA has added a Black Box Warning to the Uloric prescribing information, which is the highest possible warning. The FDA has also updated the patient Medicine Guide and is limiting the use and prescription of Uloric. It is advisable to speak with a medical professional right away if you begin to experience symptoms including, but not limited to, shortness of breath, chest pain, irregular heartbeat, numbness, dizziness, difficulty talking and headaches while taking Uloric. In addition, always speak to a healthcare professional before ceasing to take any medication and about what treatments are right for you depending on the severity of your gout as well as any family history of heart conditions.

Consult the Legal Team at The Law Offices of Peter Angelos Today

If you have been prescribed Uloric to treat gout, there may be an increased risk of suffering a heart-related illness or death while taking Uloric. That is why the pharmaceutical liability attorneys at The Law Offices of Peter Angelos urge you to consult a qualified medical professional about the risks of taking Uloric. In addition, our legal team has decades of experience representing victims who have suffered severe or fatal side effects due to prescription medication. If you or a loved one experienced a serious, heart-related complication as a result of taking Uloric as a treatment for gout, contact our Baltimore Office today.