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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
- Xeljanz Side Effects
- What is Xeljanz?
- What’s the Difference Between Xeljanz and Xeljanz XR?
- Blood Clot Symptoms
- 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?
- Get a Free Xeljanz Lawsuit Evaluation With Our Lawyers
Update: FDA Requires Heart Attack, Blood Clot, Cancer, Death Warning on Xeljanz Labeling
Based on a review of large randomized safety clinical trials, the U.S. Food and Drug Administration has concluded there is an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clot risks, deep vein thrombosis and death with Xeljanz and Xeljanz XR (tofacitinib).
The Centers for Disease Control and Prevention (CDC) is requiring revisions to the Boxed Warning for Xeljanz/Xeljanz XR, as well as 2 other JAK inhibitors, Olumiant and Rinvoq, to include information about the risks of serious heart-related events, cancer, blood clots, and death.
“Those taking Xeljanz/Xeljanz XR, 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 health care 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.
- Xeljanz Attorney Info
- Xeljanz XR Side Effects Suit
- Xeljanz Blood Clots Lawsuit
- Entyvio Side Effects Lawsuit
Xeljanz Side Effects
- Blood clot risks
- Pulmonary embolism (PE)
- Non-melanoma skin cancer
- Other cancers
- Serious infections
- Extrapulmonary tuberculosis
- Invasive fungal infections
- Jaundice (yellowing of the eyes and/or skin)
- Skin rash
- And more
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 it 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.
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  — 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.
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, 2022: 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.
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
- Fatigue or tiredness
- Cardiovascular events
Despite the risk of blood clot, 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 Xeljanz 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 lawsuits is that Pfizer defectively designed the drug.
In other words, the drug’s chemical makeup is the cause of the plaintiffs’ 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 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, including emotional distress.
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
Get a Free Xeljanz Lawsuit Evaluation With Our Lawyers
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Xeljanz and Xeljanz XR 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 medicines Xeljanz, you should contact our attorneys immediately. You may be entitled to a settlement by filing a Xeljanz lawsuit and we can help.