Xeljanz (Tofacitinib) and Xeljanz XR is an oral medication used to treat people with moderate to severe rheumatoid arthritis (RA), psoriatic arthritis (PsA), and moderate to severe ulcerative colitis (UC). It is generally given to patients taking other medications but not getting the desired results in their treatment. It belongs to a class of drugs known as Janus kinase (JAK) inhibitors. Xeljanz XR is a long-acting form of Xeljanz.
Recent FDA Warnings
The U.S. Food & Drug Administration recently concluded that there is an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with the arthritis and ulcerative colitis medicines Xeljanz and Xeljanz XR (tofacitinib).
How does Xeljanz work?
Both Xeljanz and Xeljanz XR have tofacitinib as the active ingredient. They work by decreasing cytokines, a protein that aids in controlling the immune system. During an infection, cytokines increase to fight it off. People who suffer from rheumatoid arthritis (RA) make excess cytokines that cause pain and inflammation. Xeljanz disrupts the Janus kinase (JAK) pathways from inside the cells to prevent the production of new cytokines.
The Food and Drug Administration (FDA), in 2012, approved Xeljanz to treat rheumatoid arthritis in adults. In December 2017, the drug was further approved by the FDA for the treatment of PsA. In May 2018, it was approved for treating UC.
What is rheumatoid arthritis?
Rheumatoid arthritis (RA) is an inflammatory and autoimmune disease. It affects the joints in the knees, wrists, and hands. The lining of the joint gets inflamed and damages the joint tissue. This can cause chronic pain, lack of balance, and deformity.
RA has the following signs and symptoms:
- Pain and stiffness in multiple joints
- Swelling and tenderness in joints
- Weight loss
It can also damage tissues in the heart, lungs, and eyes. The treatment includes medication called disease-modifying antirheumatic drugs (DMARDs) that slow the spread of the disease and prevent deformity in the joints.
What are ulcerative colitis and psoriatic arthritis?
Ulcerative colitis (UC) is an inflammatory bowel disease that causes irritation and ulcers in the large intestine (colon). Its severity depends on the extent of the inflammation and its location. Symptoms include:
- Abdominal cramps
- Weight loss
- Joint pain
- Liver disease
- Painful, red eyes
Xeljanz is used in the treatment of UC as it prevents the body’s enzymes from triggering inflammation.
Psoriatic arthritis (PsA) is a kind of inflammatory arthritis that can affect one or multiple joints in the body. About 15% of people with psoriasis (a disease with red, itchy, and scaly patches on the skin) develop PsA. Its symptoms include painful, swollen, and stiff joints.
Xeljanz and Xeljanz XR dosage
Xeljanz and Xeljanz XR differ in daily dosage, depending on the doctor’s prescription. They may be taken with or without certain medications called non-biological disease-modifying antirheumatic drugs (DMARD). However, they should not be taken along with strong immunosuppressants. Additionally, Xeljanz XR should not be taken for UC. People suffering from liver and kidney ailments should not use these drugs.
To treat rheumatoid arthritis patients, Xeljanz is recommended as a 5 mg twice daily dose. For people with moderate liver impairment or moderate to severe kidney impairment, the recommended dose is 5mg once daily.
For psoriatic arthritis (with DMARDS), Xeljanz is prescribed at 5 mg twice daily dose or 5mg once daily for patients with kidney or liver impairments.
For ulcerative colitis, the recommended amount of Xeljanz is 10 mg twice daily dose for at least eight weeks. After that, it is reduced to 5 mg twice daily dose. Doctors may also prescribe a higher dose of 10mg twice daily for sixteen weeks. For people suffering from moderate to severe kidney impairment or moderate liver impairment, the dosage should be half of that recommended for people with healthy kidney and liver function.
Xeljanz XR dosage
For psoriatic arthritis and rheumatoid arthritis patients, the recommended dosage is 11 mg once daily.
Side effects of Xeljanz
Since Xeljanz inhibits the immune system, it is accompanied by some common as well as serious side effects.
Common side effects include infection of the upper respiratory tract, headache, symptoms resembling cold such as the runny nose and sore throat, vomiting, and diarrhea. Upper respiratory tract infection was the most common side effect reported in the clinical trials by psoriatic arthritis and rheumatoid arthritis patients. People with ulcerative colitis reported cold-like symptoms as the most common side effect.
The serious side effects of the drug have raised health safety issues. These include the risk of cancer such as lung cancer, breast cancer, non-melanoma skin cancer, lymphoma, pancreatic cancer, and melanoma skin cancer. There is also an increased risk of pulmonary embolism (PE) and blood clots (deep vein thrombosis). These conditions can be life-threatening if not treated properly.
Other side effects for patients taking Xeljanz may include high blood pressure, infection, pneumonia, shingles, cellulitis, and gastrointestinal perforations.
Xeljanz and risk of blood clots
After getting approved in 2012, Pfizer was required to undertake a post-marketing safety clinical trial of Xeljanz (Tofacitinib) to assess its risks. It undertook the clinical trial with rheumatoid arthritis patients who were at least 50 years old and had at least one cardiovascular risk factor. In February 2019, the Food and Drug Administration (FDA) informed the public that the first safety trial had found that the use of Xeljanz may increase the risk of blood clots in the lungs in RA patients. These patients were taking Xeljanz as a 10 mg twice daily and 5mg twice daily dose. This was in comparison to another drug known as tumor necrosis factor (TNF) inhibitor.
Patients given a higher dose of tofacitinib had an increased risk of blood clots. Consequently, Pfizer transitioned patients from the higher (10mg twice daily) dose to the lower approved dose (5mg twice daily) in the post-marketing study.
Black box warning for blood clots and death
After the safety trial, in July 2019, the FDA approved new warnings about the risk of blood clots, pulmonary embolism (PE), death with the higher dose of Xeljanz and Xeljanz XR. It included a boxed warning to be printed on the drug label. This black box statement also included warnings for other serious infections such as tuberculosis and herpes zoster.
The FDA also dismissed the recommendation of taking Xeljanz as a 10 mg twice daily dose for RA or PsA. The dosage was approved only for patients having ulcerative arthritis but in limited situations. It advised patients who took Xeljanz to look out for any unusual symptoms such as sudden shortness of breath and chest pain and seek medical attention immediately.
Before the boxed warning, Pfizer did not include any warning about the increased risk of blood clots in the lungs in its drug label for Xeljanz.
FDA Safety Communication
On February 4, 2021, the FDA issued a Drug Safety Communication after completion of the clinical trials. It warned that both the higher (10 mg twice daily) as well as lower (5 mg twice daily) doses of Xeljanz carried an increased risk of severe infections, heart problems, and cancer among patients of arthritis who were administered Xeljanz and Xeljanz XR in the clinical trial. The FDA advised both health care professionals and Xeljanz patients to take it only when required in the course of the treatment.
What is Deep vein thrombosis (DVT)?
One of the serious side effects of Xeljanz is deep vein thrombosis (DVT). A form of venous thrombosis refers to a medical condition when a blood clot forms in a vein deep in the body. The clot partially or completely prevents blood from flowing through the vein. It usually happens in the lower legs or pelvis. A DVT can cause serious disability and even death.
The affected region of the body exhibits the following common symptoms of DVT-
- Tenderness, and
- Redness of the skin
- Veins near the skin of the affected area become larger than normal
Pulmonary embolism (PE)
When a clot develops in a vein but stays there, it is referred to as a thrombus (for example, deep vein thrombosis). When the blood clot detaches from the vein and travels to another part of the body, it is called an embolus.
Clots in the lungs are called pulmonary embolism (PE). It refers to a blood clot that has traveled through the bloodstream and entered the vessels of the lung. It restricts the flow of blood to the lungs and depletes the oxygen in the lungs. This increases the pressure in the pulmonary arteries.
If treated properly, a pulmonary embolism can dissolve on its own and is not fatal. However, if left untreated, it can lead to complications and even death.
Symptoms of PE
Common symptoms of pulmonary embolism include:
- Shortness of breath
- Coughing up blood
- Sharp chest pain, or pain in the shoulder, arm, neck, or jaw.
- Rapid heartbeat
- Excessive sweating
- Pale skin
- In some cases, passing out.
What is a Xeljanz lawsuit?
A Xeljanz lawsuit is a legal claim filed against the drug manufacturer Pfizer. The plaintiffs are people who took the drug as part of their treatment for rheumatoid arthritis, ulcerative colitis, and psoriatic arthritis and suffered an injury. The lawsuit offers them a chance to hold Pfizer liable and get compensation for their suffering.
Currently, the Xeljanz lawsuits are proceeding as individual cases. However, there may be class actions or multi-district litigation (MDL) in the future.
Who can file a Xeljanz lawsuit?
People who took Xeljanz and were later diagnosed with pulmonary embolism, blood clots, serious heart problems, or cancer can file Xeljanz lawsuit claims against Pfizer. They should consult a law firm and ensure that they meet the criteria to become eligible plaintiffs. They will have to show the following:
- They were prescribed Xeljanz or Xeljanz XR for their treatment.
- They took a 10mg dose of Xeljanz twice daily, and
- They developed blood clots in the lungs or suffered other medical injuries.
Patients who took a 10 mg dose of tofacitinib (Xeljanz) twice daily and think they have a case can approach a law firm for a free case review.
Grounds for filing a Xeljanz lawsuit
Xeljanz lawsuits are based on the grounds of defective design and failure to warn people of the health risks associated with the drug.
Product liability claims against pharmaceutical companies are filed based on defective manufacturing, dangerous side effects, and improper marketing of the drug. In case of defective manufacturing, the manufacturer is held liable for the drug that is improperly manufactured or somehow becomes tainted. This can be due to an error made at any point in the chain from the factory to the place where the patient gets the drug.
Improper marketing in the case of pharmaceuticals refers to inadequate warnings or instructions about the use of the drug. It includes the failure of the manufacturer to warn people about the dangerous side effects of the drug. This is one of the grounds in the Xeljanz lawsuits filed against Pfizer.
What can be claimed as compensation?
When demanding compensation, a law firm will examine the severity of the injury and the extent of suffering caused. The following can be claimed as compensation:
- Past and future medical expenses
- Lost wages
- Pain and suffering, including physical and mental, are caused by the injuries.
- Loss of earning capacity
- Other economic damages
If the case goes to trial, the jury may award punitive damages to punish the defendants for their conduct.
Statute of limitations
It is important to file a lawsuit within the prescribed time limit; else it will not be accepted. This limit is stated in the statute of limitations. It differs with each State. In some states, the statute begins to run from the day the injury occurs. In other states, it runs from the day the injured person discovers (or should have discovered) the injury. A law firm can help ascertain the exact time when the statute starts running and the deadline to file the lawsuit.
If you or a family member suffered from taking Xeljanz or Xeljanz XR, you might be eligible to file a lawsuit against Pfizer. You must have all the necessary documents, such as hospital bills and reports. Contact a law firm with a team that specializes in personal injury lawsuits. They generally offer a free case evaluation to review a potential case and examine its merits.
Do I have a Xeljanz Lawsuit?
If you or a loved one has been injured after taking Xeljanz or Xeljanz XR, you should speak with the lawyers at Johnson // Becker.
We offer a Free Case Evaluation. Please contact us using the form below or by calling us at (800) 279-6386. We would be honored to speak with you and respond promptly to every inquiry we receive.