“Black Box” Warning Placed on Gout Medicine – Uloric (Febuxostat)

“Black Box” Warning Placed on Gout Medicine – Uloric (Febuxostat)

Gout is a common type of arthritis that causes intense pain, swelling, and stiffness in a joint. It usually affects the joint in the big toe. It is the most common form of inflammatory arthritis in men, and although it is more likely to affect men, women become more susceptible to it after menopause. The Centers for Disease Control and Prevention (CDC) report that 8.3 million were affected by gout between 2007 to 2008. The number of medicines to treat gout is limited. 

Uloric (Febuxostat) is a prescription medicine, offered in the United States under license by Takeda Pharmaceuticals America, Inc., used to lower blood uric acid levels in adult patients with gout.

On February 21, 2019, the Food and Drug Administration (FDA), after a months-long investigation into the mortality risk associated with taking Uloric, has now mandated that Takeda update its prescribing information to contain a “Black-Box Warning” for increased risks of heart-related deaths and cardiovascular side effects.[1]Studies showed that “in patients treated with Uloric, 15 deaths from heart-related causes were observed for every 1,000 patients treated for a year compared to 11 deaths from heart-related causes per 1,000 patients treated with allopurinol for a year.” The FDA has also limited the approved use of Uloric as a second line drug. This means that it may now only be prescribed after allopurinol (Zyloprim), another gout medicine, either proves ineffective or the patient experiences severe side effects (usually a serious skin reaction).

A “Black-Box Warning” is the strictest warning put in the labeling of prescription drugs or drug products by the Food and Drug Administration (FDA) when there is reasonable evidence of an association of a serious hazard with the drug. It is basically a warning with a black box around it, hence the name. It is intended to make sure that users see and understand that a drug can be dangerous.   

Patients should seek emergency medical attention right away if they experience the following symptoms while taking Uloric: chest pain; shortness of breath; rapid or irregular heartbeat; numbness or weakness on one side of the body; dizziness; trouble talking, or sudden severe headache.

If you or someone you know is currently taking Uloric you should discuss your continued use of Uloric with your health care professional. Do not stop taking Uloric without first talking to your health care professional. If you or someone you knows has suffered any side effects involving Uloric, or any other medicine, you should also report those to the FDA MedWatch program. Finally, if you or someone you know has taken Uloric and suffered a heart attack or stroke you may be entitled to compensation and should contact a lawyer.


Today's blog: A common medicine prescribed to ease the symptoms of Gout has now been labeled for possibly causing heart-related deaths and cardiovascular side effects. Read the blog post today to find out more about this discovery.