In February 2019, the FDA included a box warning for the gout medicine Uloric. This warning addressed the fact that those taking the drug may be at a greater risk for heart-related and other types of deaths. Recently, attorneys have begun to file suits on behalf of those who have been injured by Uloric and their families. Currently, there are more cases that are in the investigatory phase and will likely be filed soon. Anyone who has suffered harm from Uloric or have had a loved one die while taking the medication should contact Rosenfeld Injury Lawyers to discuss their legal options.
Uloric was approved by the FDA for use to treat gout in 2009. Gout is caused by high uric acid levels in the blood, and Uloric is intended to lower those levels. Gout develops in part because the body is taking substances called purines that are found in food and drink and turns them into uric acid. Uloric is supposed to stop that process. Uloric is manufactured by Takeda Pharmaceuticals. The global market for the drug is estimated at just under $1 billion and continues to grow at an 11 percent annual rate.
When the FDA initially approved Uloric, it included a Warning and Precaution addressing the possibility of a cardiovascular event associated with use of the drug. However, at the time that the FDA approves a drug, there sometimes is only limited testing performed with some testing still to be done as the FDA requires. Here, the FDA directed Takeda to perform further studies about the possibility of cardiovascular deaths and events. The test results did indicate that there was a possibility of non-fatal and fatal heart attacks and stroke associated with the drug. Still, the FDA took no further action at the time.
In early 2017, the FDA indicated that its adverse event reporting system was indicating that there may be a safety issue with Uloric and it was evaluating the need for further regulatory action. In November 2017, the FDA issued a safety communication about Uloric. This communication was to alert the public to the results of the trial that it initially ordered after the approval of the drug. According to the FDA, the data of the tests indicated that Uloric was associated with an increased risk of heart-related deaths and death from all causes. The agency promised that it would alert the public of any additional information after conducting a comprehensive review of the test data.
Specifically, the test data quantifies the risk of heart-related deaths associated with Uloric. The data shows that the risk of this death is elevated from 11 deaths per 1,000 patients without the drug to 15 deaths per 1,000 with Uloric. While this does not seem like a significantly elevated risk, this does represent a nearly 40 percent increase in the risk of a heart-related death and is statistically significant.
As the scope of the problem became evident, there was a whistleblower lawsuit filed against Takeda in 2018. The lawsuit was filed by a former safety consultant to Takeda. The lawsuit claimed that Takeda withheld critical safety information in an attempt to hide safety issues relating to Uloric. With regard to the cardiovascular risks, the complaint stated that Takeda modified and falsified information that it sent to the FDA regarding the drug’s safety. When ordering testing and having safety dialogues with drug makers, the FDA relies on the testing conducted by the manufacturer and the information that they provide. The lawsuit alleged that this pattern of behavior resulted in the deaths of patients who were taking the drug.
The FDA took action in February 2019. After processing the results of the testing data that it was provided and conducted an advisory committee hearing, the FDA issues a box warning for the drug. A box warning is the highest form of warning that the FDA can give about a product. In addition, the FDA updated the Medication Guide to Uloric to discuss the safety risks of the drug.
One of the first lawsuits filed against Takeda was on behalf of a man who was taking the drug and suffered a non-fatal heart attack. The claim was filed in U.S. District Court for the Northern District of Illinois and claimed that Takeda knew of the risks of the drug and did not adequately warn patients of the risks. These lawsuits are in their very early phases and there have not yet been any case related developments. Takeda is in the process of answering the complaints filed against them in court, and it is likely that additional cases will soon be filed across the country. Once there is a critical mass of cases filed against Takeda, it is likely that they will be given multi-district status, allowing them to proceed commonly for purposes of discovery. Still, the cases are years away from proceeding to trial. Nonetheless, potential plaintiffs need to consider taking action now in order to bring a case within the applicable statute of limitations.