The U.S. Food and Drug Administration (FDA) sent out an alert regarding the initial findings of a Uloric gout medicine clinical safety trial.

Uloric gout medicine, generically known as febuxostat, is manufactured by Takeda Pharmaceuticals Inc. whose U.S. subsidiary is located in the greater Chicago region.

What is Gout?

Uloric gout medicine
was approved by the FDA in 2009 for the treatment of gout. Gout is a type of arthritis characterized by pain, redness and inflammation in one or more joints and high blood uric acid levels.

The pain and inflammation in the joint or joints—often the big toe of one of the feet—is caused from uric acid crystals forming within it. This arthritis has historically been associated with “high living,” as overweight people with diets heavy in red meat, shellfish, alcohol and sugared sodas are more prone to develop it.

Other factors that may contribute to the development of gout are genetics, being of the male gender—at least up until the age of 60, or having a current diagnosis of heart disease, high blood pressure, high blood cholesterol, or type-2 diabetes.

Transplant and gastric bypass patients also seem to present themselves in a higher risk category with respect to this type of arthritis.

Early Problems with Takeda’s Uloric Gout Medicine

Uloric gout medicine appeared to have more problems reveal themselves early on as compared to its drug competitor, allopurinol, manufactured by DSM Pharmaceuticals Inc.

While initial safety tests were being run on febuxostat, there were a greater percentage of cardiac arrests, strokes, and deaths from heart-related issues reported in people taking the medication. Because of this, according to a rheumatologyadvisor.com article, the FDA approved Uloric gout medicine with the caveat that Takeda Pharmaceuticals run an additional post-market clinical safety trial.

The preliminary results of this post-market testing came back in early November. There were at least 6,000 participants, half of which were taking the control competitor drug allopurinol—marketed under the brand name of Zyloprim.

The initial findings did not find Uloric gout medicine caused an increase in cardiac issues comparatively-speaking to allopurinol. When the statistics were evaluated on their own merits, however, there was an increase in risk for cardiac-related death and death from all causes.

Even though Uloric gout medicine has carried a warning regarding this on its label from its commercial approval in 2009, the FDA sent out two different medication safety alerts in mid-November 2017.

One of these alerts indicated that the drug oversight agency would be evaluating cardiac-related deaths where the decedent had also been taking febuxostat. The second alert—which was similar but more comprehensive—said that the federal agency would be looking into deaths from all supposed causes while the decedent had also been taking febuxostat.

Of concern with these FDA safety communications is that some patients will withdraw from their Uloric gout medication without the advisement and care of their physicians. A sudden removal of a medication from a patient’s system can sometimes increase the very feared and associated physical risks that they are trying to avoid. It is always recommended to seek medical care while changing out any drug regimen.