Emily Sortor  |  May 28, 2020

Category: Legal News

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Hand with two medicine pillsSide effects of febuxostat, sold under the brand name Uloric, have become of increasing concern as several patients have allegedly sickened and died from taking the medication. Recently, the U.S. Food and Drug Administration required the drug maker to include a black box warning, which is used only for medications that pose a risk of death when used as directed.

Why is Febuxostat Prescribed?

Febuxostat is a long-term treatment for gout, a type of inflammatory arthritis that attacks the joints; approximately 50 percent of cases affect the metatarsophalangeal joint of the big toe.

Caused by high levels of uric acid, gout can also cause Harrison Syndrome (also known as “tophi,” a buildup of uric acid crystals in the joints and cartilage) and kidney damage. Febuxostat, an orally administered medication, is recommended only for patients who cannot tolerate allopurinol, the usual first-line treatment for gout.

Who Makes Febuxostat?

Febuxostat was first developed by Teijin Pharmaceuticals, a Japanese drug company, in 1998. It is marketed in the U.S. through Takeda.

Are There Other Brands?

Febuxostat is available as a generic drug in many countries. Although Takeda markets the Uloric brand, a number of other U.S. drug companies sell their own versions, including Alembic, Lubin, Macleods, and Mylan.

What Are Serious Side Effects of Febuxostat?

In November 2017, the FDA issued its first safety advisory after an early clinical trial revealed that febuxostat patients suffered from cardiac-related deaths more often than those who took allopurinol for gout. Subsequent research involving nearly 6200 patients confirmed an elevated risk of cardiovascular events among the febuxostat group.

Elderly Indian man with heart problem

These included both fatal and non-fatal heart attack, stroke and impaired blood supply to the heart that required emergency surgical intervention.

Are There Other Side Effects of Febuxostat?

Minor side effects associated with Uloric include:

Are There Interactions?

Febuxostat is not recommended for patients taking theophylline drugs (such as Theolair and Slo-Bid) for respiratory conditions, or those undergoing chemotherapy for cancer.

How Does Febuxostat Work?

Febuxostat’s mechanism of action inhibits the action of xanthine oxidase (XAO), an enzyme involved in the metabolism of purines, a substance in many foods that is converted into uric acid in the body.

What Did the Drug Manufacturer Know About the Side Effects of Febuxostat?

When the FDA first granted approval for Uloric in 2009, a warning about the risk of heart attack was required for the label; additional safety studies was another condition for approval. It is worth noting that prior to its 2009 approval of Uloric, the FDA had rejected Takeda’s application twice, requesting more information on cardiovascular effects.

In 2011, Dr. Helen Ge, a former Takeda safety consultant, filed a whistleblower lawsuit, claiming that the company was aware of the side effects of febuxostat and withheld this information from the public. However, the lawsuit was dismissed in 2012. A subsequent appeal to the U.S. Supreme Court was denied two years later.

Do Febuxostat’s Risks Outweigh Its Benefits?

Reportedly, febuxostat had some trouble receiving FDA approval. It was allegedly denied approval twice before being approved in 2009. Reportedly, three studies were conducted before the approval to examine the safety and efficacy of the drug. After the drug received approval, the FDA still did require that further examination be be conducted, in the form of a fourth, post-market study.

However, critics assert that that study was conducted very poorly, not truly revealing the full effects of the drug on cardiac health. Despite the problems with the study, Cardiology Today Editorial Board Member Steven M. Nissen asserts that the new research still revealed that febuxostat may be linked to an elevated risk of death from all causes as well as death from cardiovascular issues.

Dr. Nissan was on the FDA’s Arthritis Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee, which voted on febuxostat’s use and safety. Dr. Nissen voted that the drug’s benefits do not outweigh its benefits, and proposed a “risk evaluation and mitigation strategy” for the drug. 

According to Healio, this strategy was rejected by the FDA, and the FDA did determine to leave the drug on the market. Healio explains that the FDA on the whole disagreed with Dr. Nissen, and instead determined that the drug’s benefits outweigh the risks.

However, the FDA did advise caution and determined that the drug should be used less frequently than it has been used previously. Additionally, the FDA has informed medical professionals to advise patients of the alleged cardiovascular side effects of febuxostat, says US Pharmacist.  

In general, Uloric lawsuits are filed individually by each plaintiff and are not class actions.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual Uloric lawsuit or Uloric class action lawsuit is best for you. Hurry — statutes of limitations may apply.

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