Have you or a loved one been hurt by the use of the prescription drug Uloric? Or maybe you are thinking of taking Uloric but want to understand the risks? Consumer Alert Now exists to help you be fully informed about the risks of commonly used prescription drugs and to find legal help should you suffer the ill effects of using a dangerous or defective drug or medical product.
Despite the big promises made for Uloric when it first came out, recent studies suggest it has some extremely dangerous side effects in many cases. There are several class-action and mass tort lawsuits against Uloric’s manufacturers today, and there are individual lawsuits as well. Anyone injured through the negligence of a drug manufacturer or distributor has the right to full compensation - you don’t have to suffer alone.
For answers to all of your questions about Uloric and its effects, or to connect with an attorney skilled in handling Uloric recall lawsuits, contact Consumer Alert Now by calling 800-511-0747. We operate nationwide, and we will connect you to a good lawyer who is experienced in handling tort actions.
What Is Uloric? And Why Is It Prescribed?
Uloric (febuxostat) is a prescription medication that is used to treat the disease called “gout.” Gout is a kind of arthritis caused by an overabundance of uric acid in the body. Although uric acid is naturally produced by the human body, when you have too much of it, it can build up in your joints and result in painful swelling and soreness. Uloric, then, is used to inhibit the production of uric acid so as to reduce the risk or frequency of a gout attack. It may also reduce the severity of these attacks when they occur. But it cannot treat the symptoms of gout attacks once they do occur.
However, Uloric is only to be prescribed after the alternative drug allopurinol has been tried and found ineffective. It is not a first-choice drug, as is even admitted by its own manufacturers. In recent years, it has come into question whether the drug should ever be prescribed at all due to some serious potential side effects.
Note that it is normal for it to take a few months before Uloric even starts to noticeably prevent gout attacks. And it may even cause them to spike temporarily right after you begin to take it. And again, there are other drugs that can treat gout, such as colchicine or certain nonsteroidal anti-inflammatory drugs, that may be safer and more effective. Plus, keep in mind that Uloric does not claim to cure gout and, in fact, does not. So the lack of curing gout is not a basis for a lawsuit against the drug’s manufacturers.
Possible Side Effects Of Uloric
Like all drugs, Uloric can have a variety of side effects in some users. Gout flares are among those possible side effects. Severe skin rashes, nausea, allergic reactions in various parts of the body, swelling, symptoms that mimic the flu, dizziness, difficulty breathing, chest pains, irregular heart rhythms, slurred speech, blurry vision, headaches, liver function problems, loss of appetite, side pains, and discoloration of your urine.
Any of these symptoms can be very serious, and you should not hesitate to call your doctor and/or call 911 for emergency help or visit the ER or urgent care facility without delay - whichever is most appropriate to the situation. And yet, the most serious side effect of Uloric is something else.
On the basis of a cardiovascular study, the FDA has issued a revision to the boxed warning required for Uloric. The box must now warn that Uloric results in a higher risk of cardiovascular death than those who take allopurinol instead. That explains why the latter drug is the preferred alternative to Uloric, and Uloric is only used when allopurinol has failed to work for a particular gout patient. There can be serious heart problems and even death that may be caused by the use of Uloric in some, the study suggests - so the FDA has made the label revision on that basis.
What About “Gout Diets?”
Some may wonder if any gout drug at all is really necessary. Can’t you just change your diet? The truth is that both approaches may often be necessary and equally be prescribed by your doctor. Uric acid levels in your body can increase if you eat the wrong foods, particularly in foods containing purine, which the body breaks down into uric acid (before sending it out of the body in the urine stream.)
A diet change can help, but it is not to be construed as a “cure” to gout anymore than taking Uralic is a possible cure. A better diet will help you avoid purine (and uric acid) and take in elements that can actually control uric acid levels in the body. It may also moderate gout attacks and slow down the progress of the disease.
Losing extra weight, getting complex carbs and vitamins via fruits and vegetables, staying well hydrated, cutting back on saturated fat, eating plenty of lean meats to get your protein, and moderating portions and caloric intake will all help limit the effects of gout. This, along with medications, can help lower uric acid levels and mitigate the effects of the disease.
FDA Action & A Citizens’ Petition
Uloric has not yet been recalled by the FDA, but the FDA has issued a warning label change for this drug, specifying its increased risk of causing heart problems that could even be lethal. However, in June of 2018, a Citizen Petition Letter from a consumer protection group demanded that the FDA recall Uloric from the market without delay.
The cause behind these actions was a study showing that increased rates of cardiovascular death in clinical trials. The petition states that there was unquestionable evidence that the potential harmfulness of Uloric far outweighed any supposed benefit of the drug. Therefore, it was stated that the FDA should ban the drug from sale in US markets.
But there is more to the story than just the one study that showed the dangerous nature of Uloric. The “back story” began when Uloric was disapproved for sale in the US initially. It was the first new gout medication in over 40 years when finally approved by the FDA in 2009, but it failed to get approved earlier because of signs it might increase the risk of cardiovascular health problems. And that is exactly what the new study has shown that it likely does.
After being rejected twice by the FDA, in 2009, Uloric (manufactured by Takeda Pharmaceuticals in Osaka, Japan) it was suddenly approved. It was rejected in 2005 and again in 2006. When approved in 2009, the FDA required a study be conducted by Takeda involving 6,000 participants to give greater clarity to the drug’s possible cardiovascular effects. Takeda took eight years to complete the required study (apparent foot-dragging.) The study then finally revealed that a 22% increased risk of CV death was involved in taking Uloric and a 34% higher risk of it than applies to those taking the alternative gout drug allopurinol. These results came in during 2017, but it took till 2018 for the FDA to act with a new label requirement. And they still have not issued the recall demanded by the citizens’ petition of the consumer group Public Citizen.
Today, there over a million people who’ve taken Uloric (in the US alone) - most of them before they were adequately warned of the risks by the new FDA box-label requirement. Takeda has made around $2 billion off this drug, but many may have suffered from its dangerous nature. It’s true that the black box warning issued against Uloric is the most serious the FDA ever issues, and it is also true that the FDA restricted the use of Uloric to those cases where the less risky drug allopurinol has proved ineffective. That should eliminate about 80% of the use of this drug, but those still using will have a higher risk of CV death. Plus, those who used it without adequate warning for over 8 years may have grounds for a lawsuit.
Alternatives To Uloric For Gout Patients
Gout is a very serious condition, as mentioned briefly above. It involves the abnormally excessive build up of uric acid (in crystalline form) in one’s joints. Normal quantities of uric acid are harmlessly absorbed into the blood and then sent out of the body via urination. But gout either causes an overproduction of gout or involves an inability of the body to efficiently dispose of excess uric acid.
Once the joints get “clogged up” with urate crystals, those joints get inflamed and very painful. The big toe joint is almost always badly affected, but other joints too will suffer in the same way. A proper diet, as recommended by your doctor, can ameliorate the effects of gout, but it can never eliminate them.
Since Uloric is not a safe option to treat gout, what other options are there? The first alternative is the drug allopurinol. Even that drug has some risk of CV failure and death, but at least, the risk is significantly lower.
Painkilling drugs and anti-inflammatory drugs can be used to treat the symptoms of gout. These drugs can slow the production rate of uric acid in the body OR hasten the breakdown and disposal of uric acid. Uloric is meant to reduce uric acid production, and it has been shown to do just that. But it also has been shown to have dangerous side effects that make it not the best choice for most, if not all, gout patients.
Uloric is a xanthine oxidase inhibitor drug which blocks the normal metabolic processes in the human body that would result in uric acid production. But, as we have seen, it is NOT the only option. It is NOT even the best option. Even for those who can’t take allopurinol to treat gout should not assume that taking Uloric is a good idea - even though, in this case, and this case only, it is still legal for doctors to prescribe Uloric.
Uloric Whistleblower Lawsuits
Given the increased risk of CV death that Uloric is now admitted by all to incur, it is no wonder that lawsuits are being filed against the drug manufacturer Takeda Pharmaceuticals. Not giving adequate warning is a basis for a lawsuit. However, as early as 2012, an employee of Takeda had already filed a lawsuit against his employer. The whistleblower announced that Takeda knew that Uloric had increased risk of kidney failure. He also alleged that the company knew it had fatal effects when taken with certain other drugs, including Imuran and Methadone. Finally, the allegation included that the drug increased the risk of bone marrow problems.
The lawsuit alleged that Takeda knew these facts all along but hid them from the public. Lack of public disclosure of the dangers of Uloric was done, the whistleblower claimed, in order to protect its reputation and keep making large sums of money by selling a drug it knew was actually too dangerous to be safely used by most patients. This complaint was dismissed on technicalities regarding the procedure, although the US DOJ tried to prevent that dismissal.
This whistleblower suit was a foreshadowing of things to come. It would be six more years before any action would be taken against Uloric and Takeda, but already the dangerous nature of the drug was being uncovered. Due to the exposure of these dangers by Helen Ge early on, a point of reference was established for later lawsuits.
Helen Ge’s whistleblower suit also included complaints that the manufacturer knew about cardiac side effects of the drug but did nothing. In fact, the suit claimed that Takeda knew the drug had actually caused the CV death of some and that they doctored certain documents that they presented to the FDA in order to get approval in 2009. Finally, Ge’s suit said that there was Medicare and Medicaid fraud involved since Uloric costs 100 times as much as the alternative drug allopurinol (the major alternative) and has much greater health risks.
Lawsuits Can Be Filed Over Uloric
If you took Uloric before the additional FDA black box warning label was added, and if you suffered from any of the dangerous side effects of this drug, you could be eligible to pursue damages against Takeda Pharmaceuticals.
Your first concern, if still on the drug, should be to contact your prescribing doctor to see if you should continue the medication. And if not, you need to get a replacement medication and treatment program as soon as possible. But do NOT just decide to stop taking Uloric on your own. Suddenly stopping a drug like this can itself be dangerous, so you must do it only with a doctor’s approval.
Already, numerous lawsuits against Takeda for wrongful injury or for the wrongful death of a loved one are beginning to be filed over Uloric. There are likely to be literally thousands of such lawsuits between 2019 and 2025, and experience tells personal injury lawyers that the compensation in such suits is likely to be high - if comparable past dangerous drug settlements are any guide.
Those who have suffered from heart attacks, strokes, and other cardiac problems after being on Uloric may qualify to file a lawsuit. If your spouse, parent, child, or other loved one died while on Uloric, you may be able to file in his or her place (a wrongful death suit.) You should contact an experienced personal injury and wrongful death lawyer without delay to discuss your case. Don’t assume you don’t qualify because many do. Only after a professional legal assessment will you know for sure if you have a viable case.
The Basis For A Potential Uloric Suit
Cardiac deaths are a major cause for Uloric suits. The 2017 study that was conducted by the drug’s manufacturer itself still had to admit a significantly higher risk of various heart problems when taking the drug. Many may also end up in need of emergency heart surgery, suffer non-fatal heart attacks or strokes, suffer from an inadequate blood supply, and more.
There is also a risk of various other health problems when taking Uloric. For example, kidney failure is a major risk. Uloric did not have a special dosage label for patients who took it while suffering from severe renal impairment before 2017. Today, the label limits them to 40 mg per day. This means that some suffering from kidney failure if they took Uloric prior to 2017, could qualify for a lawsuit.
The timing of when you took Uloric and the nature of the health conditions you suffered from will help determine if you can file a viable suit against Takeda. Your relation to one who died while taking Uloric, when they took it and for how long, and what they died of will impact whether you can file a wrongful death suit against Takeda. The amount you could expect to secure in a settlement will vary based on the extent of sufferings involved, to what extent it is legally established Uloric is to blame, and how aggressive and skilled your personal injury law firm is.
Failure to give proper warning on the drug product warning label and negligence in making public dangers that Takeda allegedly knew about ahead of time are major possible bases for a lawsuit. It is also possible to simply file a dangerous drug lawsuit or a defective drug lawsuit. The former is more likely since it is not known that a manufacturing defect was involved in the high-risk nature of Uloric. A dangerous drug suit means that the drug was inherently dangerous, although it was manufactured according to plan. No pharmaceutical company is allowed to market a drug that is inherently too dangerous to be used. If the company covered up the dangerous nature of the drug as well, that is only further grounds for litigation.
Class Action, Mass Tort, & Individual Lawsuits
You are not limited to filing an individual lawsuit over injuries or death that may be related to taking Uloric. Most likely, in fact, you would join an existing class action or mass tort lawsuit with others who have suffered similar effects after taking this dangerous drug. These forms of mass litigation combine numerous individual suits into one so they can be handled more conveniently by the court system.
With a class action suit, one particular plaintiff files the suit as a representative of a whole group of plaintiffs who share very similar characteristics. That is, if you suffered from very similar types of injuries for basically the same reasons (due to a dangerous drug like Uloric), you are considered a part of a “class.” The whole group is treated as if it was a single plaintiff, and so you can expect relatively standardized compensation and qualifications for joining the class action lawsuit.
Mass tort actions tend to be a little smaller than class action lawsuits and a bit more localized geographically. The plaintiffs are treated as individuals in this case, but their cases are processed together in the courtroom. A mass tort suit might involve multiple types of injuries that occurred due to the use of Uloric rather than just one class of injury. Mass torts are a bit more complex and may adjust compensation per person more than class action would.
Looking For A Uloric Attorney Near Me?
At Consumer Alert Now, we connect you to a mass tort law firm in order that you receive the compensation due to you. We are dedicated to keeping you informed about dangerous drugs like Uloric, their potentially harmful effects, and what you can do about it.
If you have suffered from heart, kidney, or certain other health problems after taking Uloric or have lost a loved one who was on this prescription drug, you may qualify to file or join a mass tort against the drug’s manufacturer.
We can help you find an experienced law firm to assess and handle your potential Uloric suit today. Contact our defective drug lawyer by calling 800-511-0747, from anywhere nationwide, anytime 24/7 for help!