Uloric’s side effects and complications are the unintended but often severe medical issues that people who take Uloric encounter. There are currently lawsuits pending over Uloric complications. The most severe side effect of Uloric is an increased risk of heart attack and cardiovascular death. However, Takeda Pharmaceutical Company, the company that manufactures and sells Uloric in the U.S., did not include this complication on the drug’s warning label for years.
- 1. Uloric’s side effects
- 2. Uloric and cardiovascular problems
- 3. Uloric and liver problems
- 4. Allergic reactions from taking Uloric, including Stevens-Johnson Syndrome
- 5. What to do if you have suffered from the side effects of Uloric
1. Uloric’s side effects
Uloric is a drug that treats gout over the long-term, but is also connected with numerous side effects. Some of the most common side effects include:
- Shortness of breath,
- Fatigue or weakness,
- Joint pain,
- Swelling or stiffness in the joints,
- Numbness in the extremities, and
- Skin rash.
However, Uloric has also been connected to some far more severe side effects, as well:
- Liver enzyme abnormalities or other liver problems,
- Heart attack,
- Unstable angina, where the blood flow into the heart is diminished,
- Heart-related death,
- Gout flares, and
- Serious skin reactions, including Stevens-Johnson Syndrome.1
2. Uloric and cardiovascular problems
The most significant side effect of Uloric is the increased potential for developing a cardiovascular problem.
After Uloric was approved for medical use by the U.S. Food and Drug Administration (FDA), Uloric manufacturers were required to conduct a postmarket clinical trial to see if Uloric caused heart problems. The results of this trial, called the CARES trial, suggested that Uloric was connected with a significantly higher risk for fatal cardiovascular events, like:
- Heart attacks,
- Strokes, and
- Unstable anginas.2
Additionally, people who had taken Uloric during the postmarket clinical trial had died for other, non-heart-related causes at a higher level than those who had taken another prescription for gout treatment.
The potential for these serious heart injuries had been realized by the FDA as early as 2009, during Uloric’s approval process. Citing the potential for severe cardiovascular problems, the FDA refused to approve Uloric in the 80 milligram and 120 milligram doses that Uloric’s manufacturers had initially requested. Instead, the FDA only approved doses of 40 milligrams and 80 milligrams, in an attempt to minimize the heart problems that Uloric could cause.3
The FDA’s concern for cardiovascular problems also led them to include a warning on Uloric’s label for heart problems.4 The FDA also required Takeda Pharmaceutical Co. to conduct the CARES postmarket trial after Uloric was approved.5
It was not until that postmarket clinical trial was completed in 2018, though, that the increased risk for developing a fatal heart condition became clear enough for the FDA to add a boxed warning on Uloric’s label.
People who are taking Uloric should see a doctor immediately if they develop any of the following symptoms of a heart attack or stroke:
- Chest pain,
- Pain spreading from your chest to your head or face, or back into your shoulder,
- Pressure in the chest area,
- Sudden numbness or weakness, especially if it is confined to one side of your body,
- A sudden and severe headache,
- Vision problems,
- Difficulties with your balance, or
- Slurred speech.
3. Uloric and liver problems
Uloric has also been linked to abnormal liver function, as well.6 Studies found that the transaminase levels of people taking Uloric were more than three times higher than normal, regardless of the dose of Uloric being taken. This put them at an increased risk of developing a liver problem. However, it was unclear if it was Uloric that was causing these heightened transaminase levels or not.7
Doctors who prescribe Uloric for people suffering from gout are supposed to conduct a liver test panel to get a baseline for a patient’s liver function before starting an Uloric treatment.8
People who take Uloric are advised to seek medical attention if they experience any of the following symptoms of a liver problem:
- Fatigue or unusual tiredness,
- Pain in the upper right side of the abdomen,
- Dark-colored urine, or
4. Allergic reactions from taking Uloric, including Stevens-Johnson Syndrome
Uloric has also been known to cause severe and potentially even fatal allergic reactions.
One of these allergic reactions is Stevens-Johnson Syndrome, a severe skin reaction identical to toxic epidermal necrolysis, but involving 10% or less of the victim’s skin. Approximately one in ten people who develop Stevens-Johnson Syndrome die from the disease.
People taking Uloric should see a doctor if they develop flu-like symptoms – like a fever, sore throat, and fatigue – that are followed by other symptoms within a few days:
- Burning eyes,
- Tingling or burning skin, or
- Ulcers or lesions on the lips, in the mouth, or around the genitals.
5. What to do if you have suffered from the side effects of Uloric
If you have suffered from one of these side effects of Uloric, you may want to consider talking to a lawyer. In some cases, you may have a legal right to compensation if the injuries you suffered were due to Uloric’s defective design, manufacturing, or marketing.
For example, Uloric’s manufacturers failed to warn doctors or patients of the risks of cardiovascular events or death associated with Uloric for years. This defective marketing of Uloric has led to numerous lawsuits being filed against Takeda Pharmaceutical. These lawsuits claim that the cardiovascular injuries were caused by Takdea’s negligence or misconduct, and seek compensation for the losses suffered by the victims of Uloric’s side effects, including:
- Medical expenses,
- Lost wages and reduced earning capacity,
- Pain and suffering, and
- Loss of companionship suffered by the victim’s family and loved ones.
The defective drug lawyers at the Shouse Law Office can help. Call them soon to begin your case before the statute of limitations runs out.
- FDA Warning Label for Uloric – 2019.
- Cardiovascular Safety of Febuxostat and Allopurinol in Participants With Gout and Cardiovascular Comorbidities.
- FDA Approval Letter for Uloric – 2009.
- FDA Warning Label for Uloric – 2009.
- See note 3.
- See note 1. See also Bohm M, Vuppalanchi R, Chalasani N, “Febuxostat-Induced Acute Liver Injury,” Hepatology 63(3):1047-9 (March 2016).
- See note 1.
- See note 1.