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.

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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.

7 Comments

  • melissaSeptember 20, 2014 at 2:42 pm

    my daddy started taking uloric and with in a year he had bone marrow trouble his bone marrow stopped producing he went from being healthy to getting blood transfusions every other week and died within 11 months this drug is bad

  • FeliciaJuly 16, 2013 at 7:38 pm

    I was given sample bottles of Uloric in March of 2013 that contained "blue," yes, "blue pills. I did not know the pills should have been green. The bottle was in a white, non-see through container and the protective silver seal was intact. I started having concentration and writing issues. I knew the change came after take the blue pills; however, because my side effect was not listed I tried to[Show More]I was given sample bottles of Uloric in March of 2013 that contained "blue," yes, "blue pills. I did not know the pills should have been green. The bottle was in a white, non-see through container and the protective silver seal was intact. I started having concentration and writing issues. I knew the change came after take the blue pills; however, because my side effect was not listed I tried to believe it was the college courses. As time went by the situation got worst. I ended up with Caused kidney creatinine serum level go from 2.65 to 3.89 in 54 days. Once I stopped taking Uloric my creatinine level went for 3.89 down to 2.84 in 11 days and would have been lower if I was not dehydrated. I experienced Rashes (neck, arms), Lack of appetite, food that did not normally affect the gout seems to affect it now (i.e. White chicken breast, etc.), occasional blurred vision, forgetfulness, poor concentration, poor writing skills, comprehension, grammar (evident in my assignment papers from Professor after I started take the Uloric), fatigue, muscle fatigue/pain/soreness (upper right arm where blood spots/rash was), taste buds have changed, wWeak bladder (especially during menstrual period), Gout flares (fingers, more so the right hand), bruising (arms and legs), knotting (above left ankle), brittle hair, and nail growth (all fingers) A representative from the company sent me a letter that spoke of my compensation request. I never asked for compensation. I only requested to know what was the pill I took. What good it compensation when you need to know what you took to fix what's wrong? Has anyone every received "blue" Uloric pills from sample bottles?

  • GraceMarch 4, 2013 at 5:29 pm

    ULORIC DANGERS!!!!!! drug Uloric, my feet started swelling and my kidneys started shutting down. Uloric drug combination side effects could also cause bone marrow failure, severe bleeding and kidney failure. ULORIC 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.

  • AndrewFebruary 12, 2013 at 4:19 pm

    In June 2011, I was given samples of Uloric, for the gout. At the time I was 16 years out from liver transplant and was a 100% , working and doing things like everyone else. I took the drug Uloric, my feet started swelling and my kidneys started shutting down. By September , I was being worked up for a kidney transplant, by November I was on Dialysis and had loss from 135 lbs. to 97 lbs before my[Show More]In June 2011, I was given samples of Uloric, for the gout. At the time I was 16 years out from liver transplant and was a 100% , working and doing things like everyone else. I took the drug Uloric, my feet started swelling and my kidneys started shutting down. By September , I was being worked up for a kidney transplant, by November I was on Dialysis and had loss from 135 lbs. to 97 lbs before my transplant on Feb.1,2012. My sister was my donor, and I'm still recovering from this mess. I feel as if I got screwed...Having to go through all of this, with no income and now on disability, for almost 2 years now.

  • MargaretDecember 12, 2012 at 1:27 pm

    So it is still happening. In February 2010 less than a month after starting Uloric my very healthy and active (apart from gout) husband complained of a headache went to sleep and never woke up.

  • karenSeptember 30, 2012 at 4:18 pm

    My husband was prescribed Uloric in February of 2012. He was also on blood pressure meds. He passed away on may first of either congestive heart failure or aneurism. All of his medical records prior to that date, stated that his heart was in good shape. He had just turned 43 and left behind two children, nine years and twelve years. There are many unanswered questions about his death. I am hearing[Show More]My husband was prescribed Uloric in February of 2012. He was also on blood pressure meds. He passed away on may first of either congestive heart failure or aneurism. All of his medical records prior to that date, stated that his heart was in good shape. He had just turned 43 and left behind two children, nine years and twelve years. There are many unanswered questions about his death. I am hearing alot of problems with uloric and am concerned that this might have caused his death.

  • ChristopherSeptember 7, 2012 at 6:30 pm

    I was on uloric for a short time and had liver and kiddeny failure,whats the deal?

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