FDA Consulted with Expert Panel Before Requiring Black Box Warning on Uloric

When the FDA first approved the gout medication Uloric (febuxostat) in 2009, they required a warning be placed on the label that alerted doctors and patients to a potential increased risk of cardiovascular events such as heart attack and stroke.

However, clinical trials that manufacturer Takeda Pharmaceuticals used to prove the medications’ effectiveness showed a potential for serious cardiovascular outcomes, so the FDA—believing more research was needed—required as a condition of approval an additional clinical trial.

The FDA recently reviewed the data from that ongoing trial, and then made the decision to require a more serious warning on the product label—the highly visible black box warning.

Uloric Black Boxed Warning
New Black Boxed Warning for Uloric

FDA Expert Panel Recommends Black Box Warning on Uloric

For the clinical trial, scientists studied nearly 6,200 patients with gout from 2010 to 2017. Some of the patients took Uloric (febuxostat), and some took allopurinol. Results showed that mortality rates were higher in those patients taking Uloric. The medication created an increased risk of heart-related deaths and death from all causes.

The FDA convened a panel of experts to review the results. They voted overwhelmingly to issue guidance that Uloric should be used only as a second-line therapy in most gout patients because the drug’s benefits did not outweigh the risks.

With a vote of 19 to 2 (with one abstention), the panel determined that patients who couldn’t tolerate allopurinol could try Uloric first, but that everyone else should use allopurinol first. They also recommended the additional black box warning.

Though the FDA doesn’t always follow the recommendations of its expert panels, it often does, as it did in this case. On February 21, 2019, the FDA announced they were requiring Takeda to include the black box warning on Uloric’s product label. They also limited the approved use of the drug to patients with gout who didn’t experience good results with allopurinol (Zyloprim).

Consumer Advocacy Group Calls for Uloric Recall

Some consumer advocacy groups feel that the FDA’s actions are not enough. Public Citizen previously called on the administration to withdraw Uloric completely from the market because, in their view based on the data, the potential cardiovascular harms outweighed any purported clinical benefit.

“In summary,” they wrote in their petition to the FDA,

“there is overwhelming evidence that the serious cardiovascular harms of febuxostat outweigh any purported clinical benefit. Febuxostat, therefore, should immediately be withdrawn from the U.S. market to avoid further preventable harm to patients.”

The FDA initially rejected Takeda’s application to approve Uloric in both 2005 and 2006, because of concerns over cardiovascular risks. They asked the company for more data on these risks both times, and Takeda complied, which led to the ultimate approval in 2009.

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E. Coli Outbreak Caused by Ground Beef

Since last month, 156 people have become ill with E. Coli food poisoning throughout 10 states. Two of those victims live right here in Virginia. Twenty of the victims needed to be hospitalized. Fortunately, there have been no deaths reported from this outbreak. The Centers for Disease Control and Prevention (CDC) began receiving reports of the outbreak in March and have determined that the source of the E. Coli is ground beef. Victims report consuming the food at restaurants and at home. As of today, the agency has been unable to identify a brand of meat, supplier, distributor, or retailer that may be responsible.

The CDC has not yet recommended that consumers avoid eating ground beef or that retailers and restaurants stop selling the product. Instead, the agency recommends that consumers make sure to handle the meat properly while preparing in order to avoid any cross-contamination. The beef should be refrigerated, and all dishes should be fully cooked to the proper temperature in order to make sure that any E. Coli contaminants are killed.

Food Poisoning

When consumers purchase food in grocery stores and restaurants, there is an expectation that what they are buying is safe to eat. Unfortunately, as this latest incident shows, the contraction of foodborne illnesses happens too frequently. Any victim who has experienced a food poisoning injury should contact a personal injury attorney to find out how they can hold the party or parties responsible for the contamination responsible.




E. Coli is a bacteria that is often found in the intestines of animals – and people – and some strains of this bacteria can trigger illnesses that are spread in food and water. When someone has been infected with E. Coli, they often have symptoms that include diarrhea, severe stomach cramps, vomiting, urinary tract infections, and respiratory illnesses. These symptoms show up within three to four days of consuming the infected food and can last up to one week.

The strain of E. Coli that the CDC has identified in this latest outbreak can also cause hemolytic uremic syndrome, which puts the victim at a high risk of kidney failure.

Let a Virginia Food Poisoning Attorney Help

If you or a loved one has contracted a foodborne illness, you may be able to pursue compensation from the party or parties responsible for the contamination. This could be the grocery store where you purchased the food, the restaurant you ate at that failed to cook the food properly, or the distributor that sold infected food to consumers.

As Shapiro & Appleton, our Virginia food poisoning attorneys can help you get the compensation you deserve for the medical expenses you have incurred, the income you have lost while recovering, and the pain and suffering you suffered. To schedule a free and confidential consultation with a member of our legal team, call our office today.

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