Published by Free Confidential Evaluation for Xeljanz Lawsuit:If you or someone you know has been harmed from using Xeljanz, reaching out to our law firm immediately is crucial. You could be eligible for monetary compensation by filing a legal claim against the manufacturer of Xeljanz, and our lawyers are prepared to help.
Table Of Contents
- Update: FDA Requires Heart Attack, Blood Clot, Cancer, Death Warning on Xeljanz Labeling
- Blood Clots, Cardiovascular Risk Factor Linked to Xeljanz: Study
- Side Effects of Xeljanz
- What is Xeljanz?
- What’s the Difference Between Xeljanz and Xeljanz XR?
- Xeljanz Timeline
- What is Rheumatoid Arthritis?
- Rheumatoid Arthritis Symptoms
- FDA Recommendation
- Can I File a Class Action?
- What Compensation Could I Be Awarded?
- Have There Been Any Settlements?
- Essential Documentation for Xeljanz Lawsuits
- Get a Free Xeljanz Lawsuit Evaluation With Our Lawyers
Update: FDA Requires Heart Attack, Blood Clot, Cancer, Death Warning on Xeljanz Labeling
The U.S. Food and Drug Administration (FDA) has concluded, following an extensive review of safety trials, that Xeljanz (tofacitinib) significantly raises the risk of serious cardiovascular events, including heart attacks and strokes, as well as cancer, blood clots, deep vein thrombosis, and death.
The journey of Xeljanz through regulatory scrutiny highlights the evolving understanding of its risks. The following is a detailed timeline outlining key FDA warnings and actions taken to address safety concerns:
| Date | Event Description | Severity Indicator | Affected Patient Numbers |
|---|---|---|---|
| May 2018 | Initial FDA approval of Xeljanz for rheumatoid arthritis. | Low | Not specified |
| February 2019 | Safety alert regarding 10 mg dosage associated with increased risk of blood clots and death. | Moderate | Not specified |
| July 2019 | Black box warning issued for the 10 mg dosage due to serious risks, including blood clots and death. | High | Not specified |
| February 2021 | Warning about increased risk of serious cardiovascular events, cancer, and blood clots. | Critical | Estimated thousands |
| 2023 | Following safety reviews, the CDC requires updated Boxed Warnings for Xeljanz and other JAK inhibitors, including Olumiant and Rinvoq. | Critical | Not specified |
Summary of Events
- May 2018
The FDA approved Xeljanz (tofacitinib) for treating rheumatoid arthritis. At this stage, no severe safety warnings were issued. - February 2019
A safety alert was issued after studies linked the 10 mg twice-daily dose of Xeljanz to a higher risk of blood clots in the lungs and possible death. This marked the first major safety concern, raising alarms among healthcare professionals. - July 2019
A black box warning—the FDA’s most severe warning—was added to the Xeljanz label. It highlighted significant risks of blood clots and mortality, especially for patients taking the higher dosage for ulcerative colitis. - February 2021
The FDA expanded its warnings to include an increased risk of major adverse cardiovascular events, malignancies, thrombosis, and death based on ongoing clinical trials. This reflected critical safety data and a reevaluation of the drug’s risks. - 2023
The FDA, following an extensive review of safety trials, mandated updated Boxed Warnings for Xeljanz and other JAK inhibitors (Olumiant and Rinvoq). These updates emphasized the heightened risks of cardiovascular events, cancer, blood clots, and mortality. The Centers for Disease Control and Prevention (CDC) supported this action to enhance patient awareness.
“Those taking Xeljanz, Olumiant, or Rinvoq should tell your health care professional if you are a current or past smoker, or have had a heart attack, other heart problems, stroke, or blood clots in the past as these may put you at increased risk for serious problems with the medicines,” FDA said.
Blood Clots, Cardiovascular Risk Factor Linked to Xeljanz: Study
When the Food and Drug Administration initially approved Xeljanz in May 2018, it required a post-marketing safety study (“A3921133”) to gauge the cardiovascular safety of the drug.
In February 2019, Pfizer announced that it would transition severely active rheumatoid arthritis (RA) or psoriatic arthritis patients who were on 10 mg of Xeljanz twice daily to 5 mg of Xeljanz twice daily.
The company made this decision after the tofacitinib Rheumatoid Data Safety Monitoring Board flagged a safety problem with the 10 mg twice daily treatment group.
A3921133 indicated that Xeljanz patients who took Xeljanz at 10 mg twice daily had an increased risk of pulmonary embolism and death.
The safety monitoring board also found that patients who took 10 mg of tofacitinib twice daily for RA had a “statistically and clinically important difference” in the rate of pulmonary embolism, lung cancer, and overall death compared to people who had taken 5 mg of tofacitinib twice daily or another drug called a tumor necrosis factor inhibitor.
Despite reports of deep vein thrombosis (DVT) and pulmonary embolism (PE) in the FDA Adverse Event Reporting System (FAERS) from 2013 to 2018, Pfizer said it found no initial safety trial results similar to those in the study.
On Feb. 25, 2019, the FDA released a safety communication to alert the public that the safety trials found an increased risk of pulmonary embolism, lung cancer, and death.
Three days later, Pfizer sent a letter advising healthcare providers of the risk.
In July 2019, the FDA approved a black box warning about an increased risk of clots and deep vein thrombosis (DVT) in people with RA who are 50 years old or older and have at least one risk factor for major adverse cardiovascular events.
Though the data found these risks in people with RA, the agency has said people who use the drug for ulcerative colitis may also be at risk.
Side Effects of Xeljanz
Understanding the side effects of Xeljanz is crucial for ensuring patient safety.
Below is a categorized overview of side effects grouped by their severity, along with tools to identify symptoms and recommended treatment options.
| Severity Level | Side Effects | Symptoms Checker Tool | Recovery/Treatment Options |
|---|---|---|---|
| Critical | – Death – Blood clots (Deep vein thrombosis, Pulmonary embolism) – Cancer (Lymphoma, Non-melanoma skin cancer, Other cancers) |
Check for symptoms like chest pain, shortness of breath, or swelling in limbs. | Immediate medical attention. Treatment may include anticoagulants for clots or chemotherapy for cancer. |
| Severe | – Serious infections (Extrapulmonary tuberculosis, Invasive fungal infections) – Organ damage |
Monitor for fever, persistent cough, or unusual bruising. | Antibiotics or antifungal medications; hospitalization may be necessary for severe infections. |
| Moderate | – Jaundice (yellowing of the eyes and/or skin) – Skin rash |
Look for yellowing of skin/eyes or rashes. | Discontinue Xeljanz and consult a healthcare provider; treatment may involve corticosteroids or other medications. |
| Common | – Nausea – Headaches – Vomiting |
Assess for persistent nausea, headaches, or vomiting. | Over-the-counter medications like anti-nausea drugs; hydration and rest are recommended. |
Understanding the side effects of Xeljanz is critical for informed decision-making and proactive health management
What is Xeljanz?
Xeljanz (tofacitinib) is a prescription drug used to treat RA, a chronic progressive disease that causes inflammation in the joints and painful deformity/immobility, most often in the fingers, wrists, feet, and ankles.
Tofacitinib works by inhibiting a signaling pathway known as the “JAK pathway” inside cells associated with RA that cause inflammation.
According to the Xeljanz website, about 132,000 people in the U.S. were prescribed the drug between January 2013 and July 2018 to treat rheumatoid arthritis.
Many more patients may have been prescribed the medication to treat ulcerative colitis or psoriatic arthritis. Pfizer reported it made about $1.7 billion off the drug in 2018.
What’s the Difference Between Xeljanz and Xeljanz XR?
Xeljanz comes in 5 mg or 10 mg tablets, and should be taken 2 times a day with or without food; Xeljanz XR is an 11 mg extended-release tablet taken once a day with or without food.
Here is a more detailed representation of the differences between them:
| Medication | Dosage | Administration | Risks Specific to Each | FDA Recommendations | Patient Population Affected |
|---|---|---|---|---|---|
| Xeljanz (5 mg) | 5 mg twice daily | Oral, with or without food | – Risk of infections – Blood clots |
– Monitor lymphocyte counts – Adjust dosage as needed |
Adults with rheumatoid arthritis, ulcerative colitis, and psoriatic arthritis |
| Xeljanz (10 mg) | 10 mg twice daily | Oral, with or without food | – Increased risk of serious infections – Higher likelihood of blood clots and death |
– Use for short-term induction; transition to lower dose if adequate response is achieved | Same as above, especially during induction phase |
| Xeljanz XR (11 mg) | 11 mg once daily | Oral, with or without food | – Similar risks as Xeljanz; potential for overdose if not monitored properly | – Recommended for maintenance therapy; monitor for adverse events | Adults with rheumatoid arthritis, ulcerative colitis, and psoriatic arthritis |
Key Takeaways
- Xeljanz (5 mg): Commonly prescribed for maintenance therapy. Risks include serious infections and blood clots. The FDA recommends monitoring lymphocyte counts and adjusting dosage based on patient response.
- Xeljanz (10 mg): Typically used for short-term induction therapy. This dosage carries a higher risk of serious infections and adverse events compared to the lower dose. The FDA advises transitioning to a lower dose after the induction phase if the therapeutic response is adequate.
- Xeljanz XR (11 mg): An extended-release option allowing for once-daily dosing. While it simplifies administration, it shares similar risks with the immediate-release forms, necessitating careful monitoring to avoid potential overdose.
FDA Recommendations
The FDA advises against starting treatment with Xeljanz in patients whose absolute lymphocyte count is below 500 cells/mm³ or who have severe renal or liver impairment. Regular blood count monitoring is crucial to reduce the risks linked to all Xeljanz dosages.
Blood Clot Symptoms
Signs and symptoms of a pulmonary embolism may include:
- Sudden shortness of breath or difficulty breathing
- Chest pain or pain in your back
- Coughing up blood
- Excessive sweating
- Clammy or bluish-colored skin
- Xeljanz Black Box Warning
Xeljanz is required to carry a “black box” warning [1] — the strongest warning available under U.S. law — regarding an increased risk of “serious infection leading to hospitalization or death; pulmonary and extrapulmonary TB, invasive fungal infections, and other opportunistic infections.”
Most of these serious infections have been reported in conjunction with immunosuppressants; FDA advises physicians to screen for latent TB infection before and during treatment with Xeljanz.
Xeljanz Timeline
The following is a timeline for the Food and Drug Administration’s public communications regarding Xeljanz:
February 25, 2019: Risk of Blood Clots in Lungs and Death
This safety communication informed patients that a safety clinical trial of Xeljanz demonstrated a heightened risk of blood clots in the lungs.
The risk applied to patients who took 10 mg twice daily for treatment of RA.
This dose had been approved only for the treatment of ulcerative colitis, not for RA patients. Pfizer responded by transitioning its RA patients who were on the twice-daily 10 mg dose to a 5 mg dose twice daily.
Doctors were cautioned to monitor their patients for signs of pulmonary embolism.
July 26, 2019: Xeljanz Black Box Warning
The most significant message of this FDA communication was that the FDA had not only approved warnings regarding Xeljanz but that the agency had also added its especially severe Boxed Warning.
The warning conveyed the dangers of using the 10 mg twice-daily dose for RA and also stated that the risk of blood clots and death could also apply to patients taking Xeljanz for ulcerative colitis.
February 4, 2021: Serious Heart Problems and Cancer
The FDA issued a drug safety communication warning the public of the results from a safety clinical trial, which indicated a heightened risk of cancer and serious heart-related problems. The safety trial also explored other potential risks of taking Xeljanz, such as blood clots in the lungs, as well as death.
Related Article: Entyvio Side Effects Lawsuit
What is Rheumatoid Arthritis?
RA is an autoimmune and inflammatory disease, which means that your immune system attacks healthy cells in your body by mistake, causing inflammation (painful swelling) in the affected parts of the body.
RA mainly attacks joints in the hands, wrists, and knees. In a joint with RA, the lining of the joint becomes inflamed, causing damage to joint tissue.
This tissue damage can cause long-lasting or chronic pain, unsteadiness (lack of balance), and deformity (misshapenness).
Rheumatoid arthritis and psoriatic arthritis can also affect other tissues throughout the body and cause cardiovascular events and problems in organs such as the lungs, heart, and eyes.
Rheumatoid Arthritis Symptoms
With RA, there are times when symptoms get worse, known as flares, and times when symptoms get better, known as remission.
Signs and symptoms of RA include:
- Pain or aching in more than one joint
- Stiffness in more than one joint
- Tenderness and swelling in more than one joint
- The same symptoms on both sides of the body (such as in both hands or both knees)
- Weight loss
- Fever
- Fatigue or tiredness
- Weakness
- Cardiovascular events
FDA Recommendation
Despite the risk of blood clots, pulmonary embolism, death, and other serious side effects with Xeljanz, FDA cautions patients not to stop taking the medication without talking to their doctor first, as doing so could also result in adverse cardiovascular events, including death.
Patients who have any of the above symptoms after taking Xeljanz should call a doctor immediately.
“We are communicating now, given the serious nature of the safety issue, to ensure that patients taking tofacitinib are aware that the FDA still believes the benefits of taking tofacitinib for its approved uses continue to outweigh the risks,”
said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.
Can I File a Class Action?
Although Schmidt & Clark, LLP, is a nationally recognized class action firm, we have decided against this type of litigation when it comes to Xeljanz.
Our lawyers feel that if there is a successful resolution to these cases, individual suits, not class actions will be the best way to get maximum payouts to our clients.
If you’ve been injured by the side effects of Xeljanz, we know you’ve suffered blood clots, and want to work with you personally to obtain the maximum compensation for the damages caused by your injuries.
Contact us today to learn more about your legal rights.
Check out the other similar dangerous drugs lawsuits we’ve taken on.
What are the Legal Grounds for a Xeljanz Lawsuit?
One of the legal grounds for Xeljanz’s lawsuits is that Pfizer defectively designed the drug.
In other words, the drug’s chemical makeup is the cause of the plaintiff’s injuries.
This argument seeks to hold Pfizer accountable for its negligence when it designed and produced Xeljanz.
Pfizer’s poor conduct at this stage in the drug’s development should make it liable for the foreseeable injuries it caused.
Another potential cause of action is a manufacturing defect.
This claim alleges that the drug was contaminated during the manufacturing process.
Xeljanz lawsuits also claim that Pfizer failed to adequately warn of the heart attack risks of taking the drug.
Doctors and patients rely on safety communications and disclaimers to make informed healthcare decisions.
Consequently, Pfizer put profit over health by not disclosing the risks, according to the lawsuits.
Xeljanz did not get a black box warning until 2019. Now that there is an adequate warning label, healthcare professionals may think twice about prescribing this drug.
What Compensation Could I Be Awarded?
A successful personal injury lawsuit would recover compensatory damages for these financial losses:
- Medical expenses, past and future
- Lost wages and reduced ability to earn an income
- Pain and suffering
If the case goes to trial, the judge may impose punitive damages as well.
What compensation can families get for wrongful death?
In a case where Xeljanz causes a death, family members of the deceased can bring a wrongful death claim against Pfizer.
In most states, plaintiffs would have to prove the following:
- The victim died
- The death resulted from the drugmaker’s wrongdoing
- Surviving family members have suffered financial hardship from the loss.
The compensation that a wrongful death lawsuit can recover is different from a personal injury lawsuit.
Rather than focusing on compensating the victim, wrongful death lawsuits focus on compensating the victim’s relatives and loved ones.
Depending on the state, the compensation for a wrongful death lawsuit can include:
- Funeral expenses
- Loss of consortium and companionship
- Lost financial security
Have There Been Any Settlements?
To date, there have been no large settlements involving Xeljanz and blood clots, or pulmonary embolisms.
However, this litigation is recent and will likely take years to resolve, with teams of lawyers spending millions of dollars trying to determine exactly what occurred, and how it could have been prevented.
Large groups of settlements do not generally occur until such time as a few cases are tried before a jury, and the manufacturer is able to more thoroughly understand its financial risk.
The first step in this process is usually having large groups of cases combined in federal court for discovery purposes. This process is known as Multi-District Litigation or MDL.
Related: Pfizer Drugs Recall Lawsuit
Essential Documentation for Xeljanz Lawsuits
If you plan to file a lawsuit related to Xeljanz, gathering the right documentation is crucial to building a strong case. Let’s look at the records you’ll need to move forward effectively.
Prescription Records
Ensure you have documentation proving Xeljanz was prescribed for your condition. This serves as foundational evidence in your claim.
Medical Records
Collect detailed medical records showing your diagnosis, treatment history, and any health complications experienced during Xeljanz use. This helps establish the timeline of events and supports your claim.
Adverse Event Documentation
Include any reports or medical records that document side effects or adverse health events linked to Xeljanz use. This is critical for demonstrating the drug’s direct impact on your health.
Financial Records
Gather bills, receipts, and any other documentation related to medical expenses incurred due to Xeljanz complications. These records will help calculate the financial damages you’ve suffered.
With the required documentation in hand, the next step involves obtaining specific medical records that strengthen your case.
Medical Records You’ll Need
Medical records are a cornerstone of your case, helping to connect your health complications to Xeljanz. Here’s what to focus on:
Complete Medical History
Provide a comprehensive overview of your health prior to taking Xeljanz to show how your condition changed after using the drug.
Treatment Records
Include detailed records of treatments you’ve received for conditions related to Xeljanz side effects, such as hospitalizations or surgeries.
Laboratory Results
Any lab tests indicating health issues tied to Xeljanz (e.g., blood clot tests, cancer screenings) should be included.
Physician Statements
Request written opinions from healthcare providers that link your health complications to Xeljanz use. These statements add credibility to your claim.
Once your lawsuit is filed, there are important next steps to follow as the case progresses.
Next Steps After Filing a Lawsuit
After filing your lawsuit, staying proactive and working closely with your attorney will help ensure a smooth process. Here’s what to expect:
Stay in Communication with Your Lawyer
Regularly check in with your attorney to stay informed about your case’s progress and any actions needed on your part.
Prepare for Discovery
Be ready to provide additional documents or information requested by the opposing party during the discovery phase.
Consider Settlement Offers
Carefully evaluate settlement proposals with your lawyer’s guidance to determine if they meet your needs.
Trial Preparation
If your case goes to trial, work closely with your attorney to prepare testimony, organize evidence, and develop a strong argument.
Filing a Xeljanz lawsuit involves a detailed process, from gathering critical documentation to navigating the legal timeline. By staying organized, informed, and proactive, you can build a compelling case that highlights the harm caused by Xeljanz. Working with an experienced lawyer will help you secure the justice and compensation you deserve.
Get a Free Xeljanz Lawsuit Evaluation With Our Lawyers
The Pharmaceutical Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Xeljanz side effects lawsuits. We are handling individual litigation nationwide and currently accepting new blood clot injury and death cases in all 50 states.
Free Case Evaluation: Again, if you were harmed after taking the ulcerative colitis medicine Xeljanz, you should contact our attorneys immediately. You may be entitled to a settlement by filing a Xeljanz lawsuit and we can help.
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