The FDA (Food and Drug Administration) has updated its safety warning for Xeljanz, a popular medication used to treat moderate to severe rheumatoid arthritis (RA). This drug may cause cancer, major cardiac events including heart attack and stroke, blood clot complications such as pulmonary embolism and deep vein thrombosis.
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What Is Xeljanz?
Xeljanz is a prescription medication approved by the FDA to treat RA in addition to psoriatic arthritis.
The following conditions may be treated with Xeljanz:
- Severe rheumatoid arthritis
- Moderate to severe polyarticular juvenile idiopathic arthritis (PJIA)
- Axial spondylarthritis without radiographic evidence of AS
- Psoriatic arthritis(PsA)
- Ulcerative colitis (UC)
Xeljanz is only available in oral capsules of 5 mg or 10 mg twice daily dose. The administration schedule is twice per day for all indications, requiring patients to take two pills twice daily.
Patients with moderate hepatic impairment should only be given the 5mg dose. Patients with severe hepatic impairment should not be given this medication. The safety and efficacy have not been established in patients with severe or end-stage renal disease (ESRD).
Is Xeljanz FDA Approved?
Xeljanz was approved by the FDA (U.S Food and Drug Administration) on November 25, 2012. The Administration approved the drug after a safety trial result showed that it was more effective than the placebo at treating RA.
However, in September 2021, the FDA reissued Xeljanz's warning label to include warnings of an increased risk of certain heart-related problems, PE (pulmonary embolism), cancer, and other health-related problems.
Why Xeljanz Is a Dangerous Drug
According to the FDA (Food and Drug Administration), patients taking this drug are at an increased risk for developing:
- Certain types of cancers (malignancies)
- Skin cancers
- Solid tumors in the liver, lung, or other organs
- Pulmonary embolism lungs (blood clots in the lungs)
- Deep vein thrombosis (blood clots in the legs, pelvis, arms, or head)
These types of malignancies may lead to death.
Patients hospitalized due to cardiovascular events were at a 21 percent increased risk. In addition, those who suffered from serious cardiac events had an 82 percent higher chance of dying than those not taking Xeljanz.
The FDA requires additional post-marketing studies to investigate further the risks associated with Xeljanz use. For example, this drug may increase a patient's risk of developing certain cancer or other life-threatening conditions.
Risk Evaluation and Mitigation Strategy (REMS)
The FDA's Risk Evaluation and Mitigation Strategy (REMS) called for implementing a Medication Guide to be provided to all patients taking this medication. In addition, the organization required Pfizer, Inc. (Pfizer), the manufacturer of Xeljanz, and EMA-USA (European Medicines Agency), to add new warnings to the drug label regarding malignancies and other serious adverse events.
According to the CDC (Centers for Disease Control and Prevention), taking Xeljanz increases the risk of blood clots and cardiovascular events in rheumatoid arthritis patients. This life-threatening condition requires immediate medical attention if a patient exhibits any symptoms associated with pulmonary embolism, deep vein thrombosis (DVT), or stroke.
The following side effects have been reported by people taking Xeljanz: nausea, fatigue, headache, upper respiratory tract infections, back pain, diarrhea, urinary tract infections, and sinus infections.
Xeljanz may be used to treat RA in addition to psoriatic arthritis. However, the FDA has stated that all patients should use this medication under the guidance of a qualified healthcare provider who will consider any underlying risk factors, such as a history of malignancies, heart disease, or blood clotting disorders.
Xeljanz: FDA Black Box Warning
In February 2019, the FDA published a drug safety warning, and Pfizer said it was revising dosage recommendations for the medication.
The FDA has mandated Pfizer, Inc. (Pfizer), the manufacturer of Xeljanz, to add a new warning label to its medication guide due to evidence showing that this prescription may cause cancer.
Thousands of patients have filed lawsuits against the pharmaceutical giant claiming the company failed to warn about serious side effects associated with Xeljanz. These include heart attack, stroke, and malignancies.
Europe Has Delayed Approving Xeljanz Based on Safety Concerns
The European Medicines Agency (EMA-USA) has delayed approving the use of Xeljanz for RA because it lacks information about the risk for cancer. In addition, the EMA-USA has stated that the drug label for Xeljanz does not mention malignancies, therefore posing an immediate threat to public health.
U.S. health regulators made a similar decision in 2012, requiring Pfizer to conduct more clinical trials regarding this matter before it could be approved to treat RA.
The FDA requires Pfizer, Inc. to conduct additional studies to determine whether Xeljanz causes increased malignancy risk. The organization decided that the drug label for this medication does not indicate whether it may increase the risk of cancer.
FDA Requires Pfizer to Add Black Box Warning for Xeljanz Following Severe Side Effects
The FDA has mandated Pfizer, Inc. to add a black box warning for cardiovascular events. Pfizer, Inc responded to the FDA's drug safety communication warning by conducting the Xeljanz Cardiovascular Outcomes Investigation study.
The FDA has also mandated Pfizer, Inc. to update the drug label for this medication regarding the risk of malignancies and other serious adverse events. In addition, the organization stated that it is unclear whether taking Xeljanz increases patients' chances of developing cancer in addition to cardiovascular diseases.
Pfizer, Inc. has decided to conduct additional clinical studies to fully assess the risk of developing malignancies while taking this medication. The FDA will continue to monitor Xeljanz's safety profile for further changes and updates.
Cases of Cancers Associated With Xeljanz
Xeljanz has been associated with various cases of cancer and malignancies, including:
- Bladder cancer
- Lung cancer and other metastatic conditions
These cancers were reported after patients had taken this medication and experienced gastrointestinal and urologic events. Squamous cell carcinoma (SCC) is a type of skin cancer that begins in squamous cells, the flat cells lining the moist surfaces of the body.
Cancer occurs when these cells divide uncontrollably and spread into surrounding tissues. A malignant tumor may also occur in which cancerous cells invade and damage tissue and organs near them.
Symptoms of Cancer-Associated With Xeljanz
Symptoms of cancer associated with taking this medication include:
- Bleeding or discharge from any place on the body
- Weight loss with no known reason
- Coughing up blood or rust-colored sputum
- Dizziness or lightheadedness when getting up suddenly from a lying position
- Nausea or vomiting
- Joint pain or stiffness that does not improve with treatment
- Swelling of the feet, legs, ankles, or hands
- Redness on skin that does not sunburn easily and appears pale in color
- Swelling of the face, eyes, lips, tongue, throat, arms, and legs
- Skin rash that spreads and causes blisters or peeling
- Changes in vision, including blurry vision, seeing double, or trouble telling the difference between blue and green
- Increased risk of blood clots
- Itching, scaling, redness, pain, or sores on the skin
- Chest pain or discomfort radiating to one or both arms
- Severe burning while urinating and frequent urination
- Shortness of breath, coughing and feeling an odd sensation in the chest
- Pain or discomfort in hips, shoulders, ribs, arms, upper back, or neck that may radiate into the jaw or shoulder
- Painful sores inside your mouth or on your lips may be caused by a condition called aphthous stomatitis
This list is not a complete list of side effects associated with taking Xeljanz.
Please note that this medication may increase the risk of serious infections and other conditions that can lead to death. This condition is especially severe if taken by patients who have been diagnosed with cancer or have been weakened by cancer treatments.
Increased Risk of Other Cancers Associated With Xeljanz
Patients who take this medication may also be at increased risk for developing other cancers, including:
- Skin cancer
- Lung cancer
- Pancreatic cancer
- Small intestine cancer
- Stomach cancer
While the FDA has not determined that Xeljanz directly causes cancers, the agency has placed this medication under added monitoring for this serious side effect.
Heart Attacks and Strokes Associated With Xeljanz
Other life-threatening conditions that have been associated with taking dangerous medication include heart attacks, strokes, and other cardiovascular problems.
Patients who took this medication were primarily at risk for small vessel ischemic disease (SVID), which occurs when plaque is deposited in the blood vessels, clogging them and preventing sufficient oxygenated blood from reaching the heart.
There have also been reports of patients suffering from cardiac ischemia with insufficient blood flow to the organ. This reaction typically occurs because fatty deposits block the coronary arteries.
Cases of Bullous Skin Disorders With Xeljanz
As reported by the FDA, patients taking this medication were also at risk for developing skin disorders such as:
- Stevens-Johnson Syndrome (SJS) causes the skin and mucous membranes to become inflamed and develop blisters or lesions that may cause scarring and skin discoloration
- Toxic epidermal necrolysis (TEN) causes the skin to detach from the body. Patients who experience this condition may die due to other complications, including sepsis and other infections.
- Pemphigoid is a rare autoimmune skin disorder that results in raised blisters filled with fluid or pus on the skin's surface.
Before taking the drug, patients are warned to tell their healthcare professionals if they have any allergies or other conditions, including the following:
- Kidney disease
- Heart disease
- Liver disease
- Low white blood cell count
- Mental health disorders, including depression or thoughts of self-harm
- Connective tissue diseases, including lupus
- An active infection
- High blood pressure
- Non-melanoma skin cancer
- Sensitivity to sunlight or ultraviolet radiation
- Major adverse cardiovascular event
- Asthma or other lung diseases
- Low blood pressure
Allergic Reactions Associated With Xeljanz
The most common side effects associated with taking this medication are mild or moderate. They include:
- General swelling
- Upper respiratory tract infection (such as the common cold)
These side effects are often transient, with symptoms disappearing after a few days.
The most serious side effects that may occur are severe, including:
- Asthma attack
- Severe allergic reaction
- Rash with fever, swollen glands, or flu symptoms
- Inflammatory bowel disease
Patients Taking Other Medications May Be at Increased Risk of Developing Blood Clots
Patients who take other medications to decrease blood clotting may be at increased risk of developing blood clots when taking the medication.
Based on clinical trials and FDA approval, some patients who have taken 10 mg of Xeljanz twice a day to treat RA with other medications that decrease blood clotting may be at increased risks of developing a heart attack or stroke.
Exacerbation of Disease With Xeljanz
Medications like Xeljanz have been associated with the exacerbation of disease in some patients.
In clinical trials, a group of 474 RA patients taking 10 mg of Xeljanz twice a day experienced an increased rate of disease flare compared with patients taking a placebo.
There were also reported cases where health conditions worsened in patients taking 5 mg to 10 mg daily and those who took 1 mg or 2.5 mg twice daily. For example, some patients experienced increased risks of serious heart-related problems, deep vein thrombosis (DVT), lung cancer, and blood clot health issues.
The medications are also used to treat people with active psoriatic arthritis, in which methotrexate or other similar medicines did not work well, and adults with moderately to severely active ulcerative colitis.
The FDA and the manufacturer have known serious blood clots and death could occur when taking ulcerative colitis medicines Xeljanz and Tofacitinib Citrate (Generic Xeljanz). However, severe problems have also been associated with other similar drugs.
The Cardiovascular Risk Factor for Rheumatoid Arthritis Patients
Xeljanz is one of the only medications, along with other disease-modifying antirheumatic drugs (DMARDs), approved for treating RA.
Rheumatoid arthritis medications, including Xeljanz, can be associated with serious side effects. Those risks include anemia and blood disorders, infection, liver problems, and cancer.
In addition to the risk of developing blood clots from taking methotrexate, there is a higher risk that patients with RA will develop cardiovascular disease.
According to one study, these patients have an increased prevalence of hypertension, obesity, impaired glucose tolerance, or diabetes mellitus compared to healthy controls. The study also found that RA patients are less likely to engage in physical activity or meet federal guidelines for physical activity.
The FDA Ordered Label Changes
The FDA made a few changes to the drug's label information regarding the cardiovascular risks associated with Xeljanz at this time, including heart attack and stroke. However, it required company officials to conduct a post-approval study to determine the risk factors associated with cardiovascular events (CVE) and death due to heart failure with Xeljanz.
The FDA has now required Pfizer, the drug manufacturer, to conduct a post-approval study evaluating whether there is an increased risk of heart failure and CVEs among RA patients taking the dangerous drug.
The study will be known as the Xeljanz Cardiovascular Outcomes Study (XVOS). It is designed to determine whether there is an increased risk of heart failure and cardiovascular death among RA patients taking Xeljanz, compared with other rheumatoid arthritis treatments.
Xeljanz and Rheumatoid Arthritis Research Study
The study will be a large, worldwide, observational registry in patients with RA that have received treatment with Xeljanz to determine if they have an increased rate of heart failure or CVEs compared to RA patients not treated with Xeljanz. Researchers hope to enroll nearly 40,000 patients with RA that have received at least one prescription for Xeljanz.
The primary objective of XVOS is to determine whether treatment with Xeljanz, as compared to any other DMARDs (disease-modifying antirheumatic drugs) or other treatments for RA, is associated with an increased risk of CVEs.
The secondary objective of XVOS is to determine whether treatment with Xeljanz, as compared to other DMARDs or other treatments for RA, is associated with an increased risk of heart failure.
Pfizer officials expect to finish enrolling patients by 2021. Study results will be available at least five years after the completion of patient follow-up. Xeljanz lawsuit claims have been filed on behalf of individuals who have suffered from serious heart problems, including heart attacks and strokes.
The Possible Side Effects of Tofacitinib Citrate (Generic Xeljanz)
A side effect is any response that is not desired and occurs with a frequency greater than one percent. Common side effects of tofacitinib citrate can include:
- Musculoskeletal pain
- Abdominal pain
- Fluid retention
- Increased heart rate
- Serious heart-related events
- Increased cardiovascular risk factor
- Mouth sores
- Serious infections
- Invasive fungal infections
- Compromised immune system
- Non-melanoma skin cancers
- Decreased white blood cell count
- Hypersensitivity reactions to the prescribed medication
- Elevated cholesterol levels
- Abnormal liver function tests
- Major adverse cardiovascular events
- Oral yeast infections
- Blood clots and death
Because of the serious risks associated with tofacitinib citrate, you should ask your doctor whether the benefits outweigh the risks before taking this medication.
How Liability Law Applies to Xeljanz Cases
Xeljanz patients who took the medication to treat rheumatoid arthritis (RA) or ulcerative colitis have filed lawsuits against the manufacturer, claiming that the drug's side effects injured them.
Among other allegations, these patients claim that:
- The pharmaceutical company knew of Xeljanz's risks but failed to warn their consumers properly
- The pharmaceutical company breached its duty to provide safe medication
- The pharmaceutical company acted negligently in conducting formal clinical studies and testing before releasing the prescription drug to the public
Xeljanz has not been found to cause complete disfigurement, blindness, or loss of limbs. However, patients who took Xeljanz reported experiencing serious side effects that put their lives in danger.
Xeljanz Lawsuits and the Risk for Blood Clot Risks
Injured patients have filed Xeljanz lawsuits claiming that the prescription drug caused them to develop serious blood clots, leading to life-threatening complications.
These plaintiffs seek compensation for the medical treatments, physical pain and suffering, mental anguish, loss of wages and earning capacity, and other damages resulting from their Xeljanz injuries.
Patients Make Claims Against the Manufacturer
In a recent Xeljanz lawsuit, a patient who took Xeljanz for RA to treat his symptoms after other medications did not work claims that he suffered several severe side effects.
He alleges that the manufacturer failed to warn him about the medication's risks and that he experienced an increased heart rate, anemia, and significant weight loss.
The Xeljanz lawsuit is still in the legal resolution process.
What Patients Can Do to File a Xeljanz Lawsuit Against the Manufacturer
Did you take 10mg of Xeljanz twice daily for RA with another medication that decreases blood clotting? Did you suffer from a blood clot, heart attack, stroke, deep vein thrombosis (DVT), pulmonary embolism (PE), major adverse cardiovascular events, or serious heart-related problems caused by a blood clot? You may have a Xeljanz lawsuit against the manufacturer.
Blood clots can occur in any large or medium-sized artery in the body and can be life-threatening. However, the risk of developing a blood clot increases when taking medications known to increase this risk. These medications are referred to as "anticoagulants."
Blood thinners work by lowering the risk of blood clots or making them less likely to cause harm. However, the side effects of Xeljanz can make it difficult to assess whether your blood is clotting normally.
Is Xeljanz XR Dangerous Too?
Xeljanz XR is a long-acting version of Xeljanz that the FDA has approved. It contains a higher dosage of the active ingredient, tofacitinib, and is given a single dose once a week.
People with rheumatoid arthritis may benefit from taking fewer doses each week, so Xeljanz XR was developed to improve convenience and efficacy. First, however, the FDA issued a request that a post-marketing safety study on Xeljanz XR be conducted.
According to lawsuits filed against Pfizer, two individuals who took Xeljanz for RA suffered from cardiac arrest and died after switching to Xeljanz XR.
The Xeljanz XR lawsuits are pending litigation.
Rosenfeld Injury Lawyer Representing Victims of Dangerous Drugs
Our law firm is currently offering free legal consultations to anyone who has experienced side effects after taking the medication to help them determine if filing a Xeljanz lawsuit is right for their situation.
Our legal team realizes that taking on a massive corporation may seem intimidating, but our Xeljanz attorneys are committed to protecting your rights as a patient injured by dangerous drugs.
If you or a loved one has suffered from a heart attack, stroke, DVT, or PE after taking the dangerous drug, please get in touch with our Xeljanz lawyers to discuss the details of your case during a free legal consultation.
Call our legal team at (888) 424-5757 (toll-free phone number) or use the contact form today to schedule a free case evaluation. All confidential or sensitive information you share with us remains private through an attorney-client relationship.
Our Xeljanz lawyers accept every personal injury lawsuit and wrongful death case through contingency fee agreements. This promise ensures you pay nothing until your Xeljanz lawsuit is resolved through a negotiated settlement or jury award.