The FDA recently announced that the gout medicine Uloricwill be required to have a boxed warning added because of the higher risk of death recently linked to the drug. A boxed warning is assigned to drugs that are known to have a significant risk profile so that patients can be informed about the possibility of side effects.

The FDA said they are requiring this warning after a comprehensive review of clinical trial results identified a higher risk of death when using Uloric, compared with another commonly prescribed gout medication, allopurinol. The clinical safety trial identified that the gout medicine Uloric was associated with a higher risk of death from all causes and specifically heart-related death.

Uloric was originally approved by the Food and Drug Administration in 2009 to treat adult gout. The medication works by lowering the patient’s uric acid levels in their blood.

There are limited medicines available to treat gout, a chronic disease that affects nearly 8.3 million adults across the United States. Any patient who has a history of stroke or heart problems is encouraged to discuss the risks of the gout medicine Uloric with their physician.

According to WebMD, some problematic symptoms include trouble talking, shortness of breath, a rapid or irregular heartbeat, weakness or numbness on one side of the body, dizziness or a sudden severe headache.

According to Healthline,  gout is characterized by soreness, pain, redness, swelling, stiffness and heat in certain joints. High levels of uric acid in a patient’s blood could lead to gout. Uloric is prescribed to treat the condition.

However, a growing number of patients who have received Uloric as a treatment for gout might not be aware of the more significant side effects, such as heart related death and death from all causes. When the gout medicine Uloric has been compared with other gout drugs, such as allopurinol, the risks might outweigh the benefits for some patients.

Other side effects, beyond heart attack and stroke risks, can affect patients for taking Uloric as prescribed by their doctors. For example, the medicine might increase the risk of gout attacks for a few months after starting the medicine while the body is going through the process of removing extra uric acid. A physician might recommend additional medication for the first few months. These drugs can include medicines like naproxen or ibuprofen.

Patients who have suffered significant consequences after using Uloric are turning to litigation as an option to hold the manufacturer accountable for side effects they say they were never warned about. Although every drug carries the possibility of side effects, when patients suffer a risk of serious adverse events that don’t match the manufacturer’s warnings, this can lead to litigation.