Xeljanz Lawsuit – Heart Attack, Stroke, & Blood Clot Risks
The U.S. Food and Drug Administration (FDA) has issued an updated warning about auto-immune drug Xeljanz (tofacitinib) and Xeljanz XR. The updated warning indicates that final results from a safety study show that Xeljanz may increase the risk for thromboembolic events, cardiovascular events and death, even when taken at the lower dose of 5 mg twice daily.
Previously, the medication had been linked to an increased risk of venous thromboembolic event (VTE) or blood clot formation in the veins when used in RA patients at the higher dose of 10 mg twice daily. New information shows that the risk is increased at all dose levels including 5mg twice daily.
This may include episodes such as deep vein thrombosis (DVT) in the legs which may result in pulmonary embolism (PE), cerebrovascular accident (CVA), myocardial infarction (MI), any of which may be serious or life-threatening. Other serious concerns about the medication have included serious infections, cancer, and sudden cardiac death.
People or loved ones of those who took Xeljanz and were injures or died after using the medication may be filing Xeljanz lawsuits seeking compensation from drug manufacturer, Pfizer.
Complications from Xeljanz may have included:
- Heart attack
- Stroke (ischemic)
- Blood clots, including pulmonary embolism, deep vein thrombosis, and arterial thrombosis
- Death (sudden cardiac death or due to one of the above injuries)
With prior warnings, the FDA required that labelling on Xeljanz and Xeljanz XR be updated to and restricted dosing of the medication. With these updated study results, the FDA is requiring that new safety information be added to prescribing labels.
Xeljanz Post Marketing Studies
Xeljanz (tolfacitinib) is a member of a class of medications known ad Janus kinase (JAK) inhibitors which work to treat immune disease by decreasing immune system activity or response. It is approved to treat autoimmune disorders including Rheumatoid Arthritis (RA), Psoriatic Arthritis (PSAPSA), and Ulcerative Colitis (UC). After its 2012 approval, Pfizer was required to undertake post marketing safety studies to examine further risks of Xeljanz.
In February 2019, results of the first safety trial showed that Xeljanz may increase the risk of blood clotting events known as venous thromboembolic (VTE) events such as deep vein thrombosis (DVT) and pulmonary embolism (PE) which may be serious or life-threatening.
The study had examined RA patients over the age of 50 who had at least one cardiovascular risk factor such as high blood pressure. The study compared patients taking tofacitinib 10mg twice daily, tofacitinib 5mg twice daily and a control group of TNF inhibitors such as Humira.
After initial study results indicated increased clotting risk in higher dosing patients, these high dose users were transferred to lower dose protocol and subsequent results showed that increased risk of death may occur at lower dose as well.
In February 2021, the FDA issued a new safety alert warning that the latest preliminary results from the clinical safety trial showed an increased risk of serious heart-related events and cancer in patients who took Xeljanz or Xeljanz XR. The warning was confirmed with an update in September 2021 which were later published in the Journal of Clinical Rheumatology. Additional updates to black box warnings were made in December 2021.
Increased risks for Xeljanz patients occurred at both the higher 10 mg twice daily and lower 5 mg twice daily dosing used for RA, PsA and UC when compared to another type of medication used for autoimmune disorders, the tumor necrosis factor (TNF) inhibitors. Prior warnings had only included the higher dose.
FDA Black Box Warning
Based on the initial blood clot warnings for larger 10 mg dosing, in July 2019 the FDA required that black box warning information be added to prescribing information. A black box warning is the most serious warning that can be issued by the FDA and requires that information be printed at the top of prescribing information enclosed in a black box.
As part of the added black box warning in July 2019, the FDA also stated that Xeljanz 10 mg twice daily was only approved for use in Ulcerative colitis but not for rheumatoid arthritis or other conditions. The agency also restricted use of Xeljanz in ulcerative colitis to patients who could not take or had not responded to other medications and stated that UC patients should be given the lowest dose possible, for the shortest duration required.
Prescribing information was also updated in December 2021 regarding additional cancer risk, new information about transplant patients, and updates to cardiovascular and clotting risk.
The current black box statement for Xeljanz and Xeljanz XR includes warnings for:
- Serious infections including active tuberculosis, invasive fungal infections, opportunistic pathogens including herpes zoster and other viruses or bacteria, along with tuberculosis.
- Blood clots including pulmonary embolism, deep vein thrombosis and arterial thrombosis.
- Increased risk of death in patients with cardiovascular risk factor.
- Epstein Barr Virus-associated lymph tissue growth in post-transplant patients.
- Lymphomas, lung cancers and other types of cancers .
Xeljanz Side Effects
Most medication side effects may be mild to moderate and will go away with time. Others may be more severe, serious, or life-threatening.
Xeljanz serious side effects may include:
- Heart attack
- Stroke (ischemic)
- Blood clots, including pulmonary embolism, deep vein thrombosis, and arterial thrombosis
- Death (sudden cardiac death or due to one of the above injuries)
Symptoms that warrant immediate treatment include:
- Swelling, pain, warmth, or redness in lower leg
- Shortness of breath
- Chest or back pain
- Sweating
- Coughing up blood
- Clammy skin
- Pale, gray or bluish-colored appearance
- Changes in consciousness
- Difficulty speaking
- One-sided numbness or weakness
Serious side effects may sometimes occur without warning or symptoms but may lead to sudden death in severe cases and should be treated as a medical emergency
Other Xeljanz serious side effects may include:
- Stomach or intestinal perforations
- Serious infections
- Liver enzyme elevation
- Laboratory abnormalities
- Infection Risk
- Breast cancer
- Lung cancer
- Pancreatic cancer
- Prostate cancer
- Melanoma
- Non-melanoma skin cancer
- Lymphoma
- Other types of cancer
- Allergic or hypersensitivity reactions
Bothersome or persistent side effects should be reported to a healthcare professional. All sudden or severe symptoms should be treated as a medical emergency.
Xeljanz Lawsuit Claims
Pfizer is facing numerous lawsuits filed by people who took Xeljanz for RA, PsA or UC and suffered injury. Injuries which may have been caused by Xeljanz and cited in lawsuits include:
- Heart attack
- Ischemic stroke
- Deep vein thrombosis (DVT)
- Pulmonary embolism (PE)
- Death due to DVT or PE
- Death (sudden cardiac death or due to one of the above injuries)
Though a number of lawsuits have been filed, no additional actions or settlement offers have been announced.