FDA Adds Black Box Warning to Gout Drug Uloric Over Increased Risk of Death – GoodRx

Although a black box warning is the most serious type of warning given by FDA for prescription drugs, this isn’t the first safety warning surrounding Uloric. In fact, Uloric had some difficulties getting approved initially because of serious side effects, and there has even been a petition to remove Uloric from the market.

Under the current black box warning, the FDA is recommending that Uloric only be used in patients who do not benefit from or cannot use allopurinol.

Here’s what you need to know.

What is Uloric?

Uloric is used to treat gout, which is a buildup of uric acid in the joints that can cause pain, redness, swelling, tenderness, or warmth at the affected joint. At a cash price of over $400 for a month’s supply, it can be very expensive.

What should I do if I have to take Uloric?

Unfortunately, there are few medications to treat gout. So, if your gout symptoms don’t respond to allopurinol (Zyloprim), you will likely be prescribed Uloric.

If you take Uloric and begin to experience any of the following side effects, seek medical attention immediately:

  • Chest pain
  • Shortness of breath
  • Rapid or irregular heartbeat
  • Numbness or weakness on one side of your body
  • Dizziness
  • Trouble talking
  • Sudden severe headache

However, do not stop or discontinue this medication without first talking to your doctor, as doing so can cause a gout flare.

What should I tell my doctor before starting Uloric?

As with starting any medication, you should disclose all prior health issues and current medications to your doctor. However, given Uloric’s new boxed warning, be sure to speak with your doctor if you have a history of heart problems or stroke—this will be an important factor for deciding if Uloric is safe for you.

What is the common dosing for Uloric?

Uloric is available in 40 mg and 80 mg tablets. Patients should begin taking Uloric at a dose of 40 mg once daily. But if gout symptoms aren’t properly treated after two weeks of use, doctors will bump up to the dosage to one 80 mg dose daily.

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