Uloric (Gout Drug) Lawsuit Information

If you have been given Uloric for a medical condition, you may have experienced adverse side effects. While many of these side effects have been listed in the warnings on the prescription medication, you may have been unaware of other potential dangers. People who have faced unusual effects of the medicine without proper warning may be eligible to participate in an Uloric lawsuit.

What is Uloric and What is It Used to Treat?

The generic name for Uloric is febuxostat. It is designed to treat people with gout by reducing the levels of uric acid in the person. This gout drug is categorized as a xanthine oxidase inhibitor and comes in either 40 mg or 80 mg as approved doses. The lowest dosage is usually prescribed first and taken once a day. For those with more extreme symptoms, the higher dosage may be necessary. The goal is to reach a level of serum uric acid of less than 6 mg/dL. Lower acid levels reduce the pain and other symptoms of gout. A high level is known as hyperuricemia.

Patients may notice an increase in gout symptoms when they first start taking the medication. This is considered normal and they shouldn’t discontinue Uloric. According to the medication instructions, other medication may be given to control the symptoms. A blood test may be done on a regular basis to ensure the drug is helping.

What is Gout?

Gout is a type of arthritis that is often painful. It occurs when the level of uric acid in the bloodstream is well above normal levels. Normally, this acid dissolves in the bloodstream or leaves through urine. If too much is produced, it can accumulate around joints in the body as crystals, which is most often seen in the big toe.

The symptoms of gout include pain around the joint and inflammation as well as redness. It can be difficult to walk and move around. Certain foods can increase the risk of gout while specific medical conditions can also lead to the condition.

Some medications treat the attacks that come with gout while others focus on treating the complications. Uloric falls into the second category. The hope is that by lowering the levels of uric acid, it will reduce the symptoms of the gout, so the person can function normally with little to no pain. Medication is often given along with a change in diet to reduce the amount of uric acid in the body.

Warnings for Uloric

One of the most important warnings for this medication is not to take it if the person is also taking mercaptopurine or azathioprine. A patient must also tell their doctor if they suffer from or have had the following conditions:

• Heart attack or other cardiovascular conditions
• Stroke
• Cancer
• Heart disease
• Liver disease
• Kidney disease or other renal conditions
• Lesch-Nyhan syndrome
• Organ transplant

Besides the warnings to tell a doctor if a patient had experienced the above conditions, there are also warnings about possible side effects. An allergic reaction to the drug could be characterized by swelling in the face or even the throat as well as difficulty breathing. It may also cause a severe skin reaction, which would be seen with a red or purple rash that peels and blisters as it spreads. It may be accompanied by fever and a sore throat as well as pain in the skin and burning eyes.

If a person experiences a severe reaction, they should get medical help. These symptoms include the following:

• Muscle aches
• Unusual bruises
• Severe weakness
• Skin rash
• Fever
• Flu-like symptoms
• Swollen glands
• Yellowish skin or eyes

It can be several weeks after starting Uloric before the symptoms begin.

Medical help is needed immediately if the patient feels any symptoms of a heart attack, other heart-related conditions or signs of a stroke. They must also get help if they start showing signs of liver problems, such as dark urine and a yellowish tint to the skin or eyes as well as extreme tiredness.

More common side effects from taking this medication include nausea, a mild rash and a flare-up of your gout. Liver function tests may be abnormal as well. Some side effects will go away as the person continues taking the drug.

There is also a list of rare side effects that range from depression to severe sunburn to sudden numbness in the extremities. There is even a mention of mental effects, which include seeing and hearing things that do not exist and having aggressive thoughts.

Potential Uloric Lawsuits

Even with the long list of side effects and potential dangers of taking Uloric, there are potential lawsuits against this medication and the manufacturer, Takeda Pharmaceuticals. The medication has been available in the US since February 2009. Since that time, the drug has been associated with several dangerous side effects, which include liver failure, kidney damage, heart attacks and cardiac arrest, bone marrow failure, strokes and severe bleeding.

Since receiving reports of complications from the dangerous drugs, the Food and Drug Administration (FDA) has issued safety warnings. The first was in January 2011 with a second one coming in November 2012. The agency reviewed a safety study and determined that improved safety communication was necessary to protect patients.

The Risk of Rhabdomyolysis

Rhabdomyolysis is a serious condition which has been linked to Uloric and may be fatal. This condition occurs when the muscle fibers in the body are broken down. They then release myoglobin into the bloodstream, which can reach the kidneys were it clogs them and prevents them from functioning normally.

One of the dangers of this condition is that it manifests in different ways to each patient. Diagnosis can take longer, but some of the common symptoms include:

• Dark or red colored urine
• Decrease in urine production
• Tenderness in muscles
• Stiff muscles or achiness
• General weakness as well as weakness in specific muscles

If the kidneys stop working, it can lead to death.

Liver Failure Tied to Uloric Use

Another concern is liver failure for those who take Uloric. Clinical trials that were done before approval showed that liver enzyme levels were higher than normal in up to six percent of patients who were taking the drug. Normally, the enzyme levels drop back down to normal after the medication was discontinued.

Some of those tested showed levels up to three times what is the top limit of normal, which could lead to liver failure. Symptoms of this condition include the following:

• Nausea
• Vomiting
• Fatigue
• Abdominal pain
• Confusion
• Jaundice
• Malaise
• Changes in personality
• Abnormal behavior

This condition could lead to death.

Whistleblower Lawsuit Against Takeda

A former employee of the manufacturer alleged that the company withheld essential safety information about possible side effects of Uloric. A whistleblower lawsuit was filed in 2012 which claimed that the manufacturer failed to report the severe side effects and results and as a result defrauded Medicare and Medicaid.

The allegations stated that serious consequences resulted from taking Uloric with other medications on the market, such as warfarin, Imuran and methadone. In fact, claims were made that the interactions from these drugs caused the death of several patients.

While the lawsuit was dismissed later in that year, in August of 2013, the federal government issued a statement in support of the claimant which urged the court to reconsider and continue the investigation.

FDA Involvement

The FDA got involved in February 2019 and issued a statement that Uloric may be more dangerous and lead to more fatalities than allopurinol, another drug to treat gout. The agency also determined that a boxed warning is required to be included along with a medication guide for patients. In the future, the FDA will only approve the use of the drug for patients who cannot be treated with the other medication compared to how it has been used in the past.

Allopurinol, which is known as Zyloprim, is another medication used to reduce the levels of uric acid. It can be ineffective and some patients are allergic to it, which is why the doctor will often prescribe Uloric.

What to Do If You’ve Taken Uloric

If you’ve taken this medication and have suffered side effects or injury or a loved one has taken it and died from complications of a heart-related death or other conditions, you may be eligible to file a lawsuit. It is the job of the manufacturer to make patients aware of the risks associated with taking a medication before allowing it be to used in treatment. This includes possible drug interactions, cardiovascular events and other accidents.

You can get a free consultation with an attorney who is experienced in these practice areas and handling these kinds of cases with medication and medical devices. Look for an attorney with experience in personal injury, which may include medical malpractice, IVC filter lawsuits, car accidents, nursing home abuse, premises liability and more. They can provide legal advice to help you determine if your next step against defective medications should be litigation.

Class actions can allow the client to claim damages for the cost of medical care as well as lost wages and pain and suffering. In the case of the death of a loved one, you may be eligible for a wrongful death lawsuit. This can happen anywhere in the US, from Florida to New Jersey to New York.

Lawyers can determine the amount of damages you can claim based on your medical costs and other factors. They may be able to negotiate a settlement on your behalf or even to fight for your rights in court for compensation against negligence.

If you have suffered serious side effects from taking Uloric and believe you may have a claim, contact Krasno Law Firm today for a free case evaluation. Tell the team your story and find out if you qualify to participate in a Uloric lawsuit.