Uloric Side Effects Hidden By Takeda, Whistleblower Alleges

A whistleblower lawsuit accuses Takeda Pharmaceuticals of hiding potentially harmful side effects of Uloric, a gout medication. 

The complaint, filed by Helen Ge, alleges that the Japanese drug maker defrauded Medicare and Medicaid by failing to report that Uloric could cause dangerous side effects when used in combination with other drugs, including digoxin, imuran, methadone, and warfarin. The drug interactions have lead to the death of some patients, Ge claims.

One of the deaths occurred when Uloric was used in combination with methadone, leading to a drug overdose. Ge’s examination of the autopsy report appeared to reveal that Uloric contained the same metabolizing enzyme, CYP1A2, as methadone, causing it to stay in the body longer and increasing the risk of a fatal methandone overdose.

Ge, a former safety consultant at the company, alleges that Uloric drug combination side effects could also cause bone marrow failure, severe bleeding and kidney failure. She also claimed that the company altered and falsified adverse event reports submitted to the FDA, changing important details to make the Uloric side effects appear less serious than they really were.

The reason for the changes, Ge claims, was so that Uloric appeared to be more competitive against allopurinol, an older gout drug. At $5 per pill, Uloric is more expensive, and severe and harmful side effects could have hurt the drug’s sales potential.

Uloric (febuxostat) was approved for the treatment of gout by the FDA in 2009. According to allegations raised in the whistleblower lawsuit, Medicare and Medicaid overpaid for the medication as a result of the drug maker’s failure to disclose the risk of the harmful drug interactions.

Under the qui tam provision of the False Claims Act, whistleblowers who report a false claim against the government may be entitled to receive a portion of any money that the government recovers. In return, the whistleblower must be the first to bring the case to the government’s attention, and must not publicize the claim until the DOJ decides to prosecute the claim.

The lawsuit was filed in the U.S. District Court for the District of Massachusetts on behalf of Ge, the United States of America, 24 states and the District of Columbia on January 25.

Takeda officials have not commented on the lawsuit, saying they have not yet been served with the claim. The case comes as the company continues to face mounting Actos litigation costs associated with lawsuits filed by individuals who developed bladder cancer after using the type 2 diabetes drug and allege that the drug maker failed to provide adequate warnings.