For the second time in just over a year, the FDA has added serious health warnings for patients that may be prescribed the gout medication Uloric, also known by its generic name febuxostat.
The drug is prescribed to many of the 8 million Americans suffering from the severe arthritic condition, and has been shown to be effective since its introduction in 2009. However, many patients still don’t know the full risks they face.
And lawyers say the drug’s manufacturer, Takeda Pharmaceuticals, didn’t act quickly enough to prevent injury to thousands of users.
In February of 2018, the FDA added warnings to Uloric’s prescribing information to alert patients they may face increased risks of severe skin disorders, including Stevens-Johnson Syndrome (SJS), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) and toxic epidermal necrolysis (TEN).
Uloric was marketed as an alternative to the gout medication allopurinol (Zyloprim), which already carried significant risks for skin disorders. However, recent studies showed many patients faced similar risks from Uloric as they did with allopurinol.
SJS and TEN can lead to bumps, spots, blisters or rashes over much of the body, as well as swelling or bleeding in the mucous membranes of the eyes, mouth, nose and genitals. In as many as 30% of the cases, it can be fatal.
On February 21st, the FDA added its most prominent warning, called a black box warning, to the packaging of Uloric. This time, the agency alerted patients of an increased risk of heart attacks, heart-related death and stroke.
The advisory came after a post-marketing clinical trial of more than 6,000 patients showed health concerns. As many as 15 out of 1,000 patients experienced heart-related death while taking Uloric, and as many as 26 out of 1,000 patients experienced non-specific death while on the drug.
The FDA narrowed the major risks to heart attacks, heart conditions and strokes, and advised patients and doctors to monitor for the following symptoms while using Uloric:
Anyone affected is urged to speak with their doctor immediately, but should not discontinue taking the medication until doing so.
With studies showing more than 3 percent of patients taking Uloric may have a higher risk of stroke, heart-related death, or serious skin disorders, critics have asked why the manufacturer didn’t warn patients sooner.
In fact, studies revealed these risks years ago, but Takeda Pharmaceuticals didn’t add new warnings to Uloric until required to do so by the FDA. As a result, they may be liable for substantial damages to those injured before the warnings took affect.
Lawyers are investigating lawsuits on behalf of those who suffered:
Unfortunately, tens of thousands of patients may have suffered serious side effects of Uloric without knowing the cause.
Since the physical, emotional and financial damages associated with these conditions can be extreme, those who were affected or lost a loved one may be entitled to substantial compensation.
It’s important to talk with a lawyer about your options. It costs nothing unless you receive compensation, but you only have a limited amount of time to take action.
Contact DrugNews today to speak directly with a lawyer and learn more.
FDA. FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat). (February 21, 2019). Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm631182.htm
Uloric Highlights of Prescribing Information. FDA. (February 2018). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021856s012lbl.pdf
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