What is Xeljanz XR?
Xeljanz and Xeljanz XR (generic: tofacitinib) are prescription brand-name medications that the U.S. Food and Drug Administration (FDA) has approved to treat rheumatoid arthritis, psoriatic arthritis, and moderate to severe ulcerative colitis. Xeljanz XR is an extended-release (long-acting) form of the prescription drug.
These tablets are long-acting because they release the medication slowly as they pass through your digestive system. Xeljanz tablets come in 11 mg and 22 mg strengths.
How Does it Work?
The ulcerative colitis medicine Xeljanz is classified as a Janus kinase (JAK) inhibitor which blocks the immune’s system production of cytokine, a protein integral to the body’s inflammatory responses. By suppressing the immune system, swelling decreases, which provides relief to the patient.
Xeljanz was first approved by the U.S. Food and Drug Administration (FDA) in 2012 as a treatment for adults with RA who had not responded well to methotrexate. Xeljanz was subsequently approved in 2017 to treat psoriatic arthritis in patients for whom methotrexate also failed to relieve joint pain and swelling. In 2018, FDA issued Xeljanz to treat ulcerative colitis.
Related Article: Xeljanz Lawsuit Update
What's the Problem With Xeljanz?
In 2019, the National Law Review reported on a surge of dangerous drug lawsuits filed over Xeljanz. The medicine, which works by suppressing a patient’s immune system, resulted in some users suffering an increased risk of blood clots and deep vein thrombosis (DVT).
Later that year, the FDA shared preliminary results from its post-marketing safety study of Xeljanz highlighting data linking the drug to blood clotting problems. Specifically, the agency reported 19 cases of blood clots and/or deep vein thrombosis in the lungs in Xeljanz patients treated with the 10 mg twice daily dose compared to three cases in patients who received TNF blockers.
The agency further reported 45 patient deaths among people who took 10 mg of Xeljanz twice daily compared with 25 patient deaths for those who received TNF blockers.
Xeljanz Black Box Warning
As a result of the above findings, FDA required Pfizer to add a black box warning to its Xeljanz product labels, alerting patients and healthcare providers of the increased risk of blood clots and death with twice-daily doses of 10 mg each.
These risks most affected rheumatoid arthritis patients who were at least 50 years old and demonstrated at least one increased risk factor. Pfizer did not warn about blood clot risks prior to the placement of this drug safety communication warning, which was ultimately added in July 2019.
Xeljanz Side Effects
- Blood clots in the lungs
- Pulmonary embolism (PE)
- Deep vein thrombosis (DVT)
- Non-melanoma skin cancer
- Lung cancer
- Other cancers
- Heart attack
- Cardiovascular risk factor
- Major adverse cardiovascular events
- Ulcerative colitis
- Chronic inflammatory conditions
- Serious infections
- Immune system problems
- Extrapulmonary tuberculosis
- Invasive fungal infections
- Jaundice (yellowing of the eyes and/or skin)
- Breath chest pain
- Sudden shortness of breath
- Skin rash
- Other adverse events
Related Article: Side Effects of Xeljanz Explained
Xeljanz Timeline of Events
- February 25, 2019: Risk of Blood Clots in Lungs and Death - The FDA warned patients that initial safety trial results demonstrated an increased risk of blood clots in the lungs (pulmonary embolism) and heart attack with Xeljanz. The increased risk was applied to patients who took 10 mg twice daily for the treatment of rheumatoid arthritis (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.
- July 26, 2019: FDA Approves Boxed Warning - FDA required a statement indicating that the agency had not only approved warnings regarding Xeljanz but that it had also added a Boxed Warning, the strongest warning allowed by law. The warning conveyed the dangers of using the 10 mg twice-daily dose for rheumatoid arthritis and also stated that the risk of blood clots, heart attack, and death could also apply to patients taking Xeljanz for ulcerative colitis.
- February 4, 2021: Serious Heart Problems and Cancer - FDA Drug Safety Communication published a warning to the public of the results from a safety trial that found an increased risk of cancer and serious heart-related problems with Xeljanz. The trial also looked at other potential risks of taking Xeljanz, including blood clots in the lungs and death.
- September 1, 2021: Serious Heart-Related Events, Cancer, Blood Clots, and Death - "Based on a completed U.S. Food and Drug Administration (FDA) review of a large randomized safety trial, [the FDA] concluded there is an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with arthritis and ulcerative colitis medicine Xeljanz."
Clinical Trials Link Xeljanz to Blood Clot Risks in the Lungs
In a post-marketing study, Xeljanz was found to dramatically increase the risk of a blood clot developing and then traveling to the lungs to cause a pulmonary embolism, especially when taken at a high dose.
The study looked at 4,400 test subjects, all of whom have at least 2 cardiovascular events, and was designed to compare the efficacy and safety of Xeljanz to a tumor necrosis factor inhibitor drug in people with rheumatoid arthritis.
The trial aimed to find out whether Xeljanz was more or less safe for people who have increased risk for a major adverse cardiovascular event, and monitored their heart health and whether they developed malignancies, serious infections, or lung cancer.
Pfizer intervened in the study on February 19, 2019, to take participants off of the twice-daily dose of 10 milligrams. The decision was made after Pfizer was notified by the Rheumatology Data Safety Monitoring Board that a high number of participants in that dosage level were developing clots in their lungs and suffering pulmonary embolisms and serious infections.
People taking the high dosage of Xeljanz were suffering pulmonary embolisms more than five times as often as people taking the tumor necrosis factor inhibitor drug. They were also suffering pulmonary embolisms three times as often as other Xeljanz participants in that trial and others like it.
Pfizer’s announcement was likely spurred by the FDA’s announcement about Xeljanz in February 2019, which warned the public of the potential for a blood clot reaching the lungs after taking the drug.
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.
I Am Eligible to File a Xeljanz Lawsuit?
Patients who experienced complications after using the unapproved 20 mg/day dose of Xeljanz (10 mg twice per day) may have the right to seek compensation for their damages. That includes medical expenses, lost wages, pain and suffering, and other emotional and economic losses victims and their families may have suffered due to injuries or the tragic, untimely death of a loved one.
What Compensation Could I Be Awarded in a Xeljanz Lawsuit?
The compensation you might recover for your Xeljanz injury will depend on the type and severity of your injury and the extent to which your injury has caused you to suffer physical, financial, and emotional damages.
When you hire our medical devices law firm to represent you in your pursuit of compensation, we will thoroughly research all the ways in which you have suffered blood clots. Depending on what our research uncovers, you could be eligible to recover any or all of the following types of damages:
- Past and future medical expenses
- Past and future pain and suffering that results from your injuries (both physical and mental)
- Wage loss
- Other economic losses
- Punitive damages
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 Xeljanz lawsuit can recover is different from a personal injury lawsuit.
Rather than focusing on compensating the victim, wrongful death Xeljanz 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 Xeljanz 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.
Xeljanz Lawsuit Allegations
Under most state laws, a patient injured through the use of a defective drug can bring a lawsuit based on the following legal theories:
- Design Defect: When a drug is manufactured per design specifications, but the design itself renders the drug ineffective or unsafe;
- Manufacturing Defect: When a drug is safely designed, but has a defect through the manufacturing process, rendering it dangerous or unsafe; and/or
- Failure to Warn: When the drug manufacturer fails to warn the public of the risks or to provide adequate instructions about the use of the drug, thereby rendering it unsafe or dangerous.
All states enforce a statute of limitations that limits the amount of time you have to file a lawsuit against a drug manufacturer. A member of our legal team can inform you of your state’s laws.
Can I File a Class Action?
Only a qualified attorney can determine whether you are eligible to file a lawsuit against Pfizer, the maker of Xeljanz, which is why we are currently offering free case evaluations. Simply fill out the confidential evaluation form below to contact our law firm now.
PLEASE NOTE: Our attorneys have decided against the filing of a Xeljanz Class action lawsuit in this litigation, and instead are filing individual Xeljanz lawsuits on behalf of injured parties and/or their family members. We strongly believe that individual suits, and not a class action, are far more beneficial to our clients in terms of overall payout, lawyer fees, and control over their own cases. Contact us today to learn more about your legal rights.
Get a Free Xeljanz XR Lawsuit Evaluation With Our Lawyers
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial attorneys that focus on the representation of plaintiffs in Xeljanz XR lawsuits. We are handling individual litigation nationwide and currently accepting new blood clot injury and death cases in all 50 states.
Free Xeljanz XR Lawsuit Evaluation: Again, if you were harmed after taking Xeljanz XR to treat rheumatoid arthritis, you should contact our attorneys immediately. Xeljanz XR patients may be entitled to a settlement for medical bills by filing a Xeljanz XR lawsuit and our attorneys can help.