Xeljanz Lawsuit Information

Xeljanz

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Patients who use the arthritis and ulcerative colitis drug Xeljanz may face an increased risk of potentially life-threatening blood clots possibly leading to pulmonary embolism or deep vein thrombosis.

Xeljanz is a prescribed medication used to treat rheumatoid arthritis (RA), psoriatic arthritis (PSA) and ulcerative colitis, all of which are autoimmune diseases that can cause pain and discomfort and can significantly diminish a person’s quality of life. RA and PSA are conditions that can result in joint swelling, pain and stiffness and colitis is a condition that can result in abdominal pain and cramping, diarrhea, weight loss and fatigue. The purpose of any treatment approach for RA or PSA is to reduce pain and swelling, maintain mobility and range of motion, and slow damage to the joints. For ulcerative colitis, treatment is aimed at preventing flare-ups, relieving the symptoms of the disease and giving the colon a chance to heal. Pfizer’s Xeljanz drug has been shown to relieve symptoms of RA, PSA and colitis in some patients, but there is also an emerging body of evidence that suggests patients taking Xeljanz may face an increased risk of dangerous and potentially deadly blood clot injuries.

Xeljanz Alternatives for Rheumatoid or Psoriatic Arthritis

An overactive immune system can contribute to inflammatory conditions like rheumatoid arthritis and psoriatic arthritis, and medications like Xeljanz are meant to work by decreasing the activity of the immune system, thereby reducing the severity of symptoms and slowing the progression of the disease. There is no cure for rheumatoid arthritis or psoriatic arthritis, but Xeljanz can help relieve the most common symptoms of these diseases, including pain, tenderness and swelling in the joints. Unfortunately, like most prescription drugs, Xeljanz treatment comes with a host of potential side effects, many of which may outweigh the possible benefits of the medication. If you are struggling with an autoimmune disease like RA or PSA, you could potentially benefit from the use of alternative remedies that can reduce the discomfort associated with these conditions without causing blood clots, such as:

  • Stretching the muscles around the affected joints
  • Dynamic, low-impact exercises like swimming and cycling
  • Heating or icing sore areas
  • Reducing physical and emotional stress
  • Adhering to an anti-inflammatory diet
  • Taking supplements like fish oil, turmeric and curcumin to combat inflammation
  • Eating foods that are rich sources of probiotics, or taking probiotic supplements

What is Xeljanz?

A drug indicated for the treatment of rheumatoid arthritis, psoriatic arthritis and ulcerative colitis that has been linked to an increased risk of dangerous blood clots in the lungs and deep veins of the body.

Xeljanz (tofacitinib) and Xeljanz XR (extended release) are oral medications manufactured by Pfizer and prescribed to adults experiencing symptoms of RA, PSA and ulcerative colitis. Rheumatoid arthritis is a condition that occurs when the body attacks its own joints, resulting in swelling, pain and a loss of function. Psoriatic arthritis is another form of arthritis that can affect certain people with the skin condition psoriasis. Ulcerative colitis is a chronic, inflammatory bowel disease that affects the colon and causes long-lasting inflammation and ulcers in the digestive tract.

Xeljanz belongs to a class of prescription drugs known as Janus kinase (JAK) inhibitors, which are disease-modifying antirheumatic drugs designed to inhibit the activity of one or more of the Janus kinase family of enzymes. By doing so, these medications can relieve the symptoms of RA and other inflammatory diseases. Xeljanz was originally approved in 2012 for the treatment of RA in patients who did not respond well to methotrexate, and it was additionally approved in 2017 for the treatment of PSA in patients who did not respond well to methotrexate or nonbiologic disease-modifying antirheumatic drugs (DMARDs). Xeljanz has also been approved as a treatment for adults with moderate to severe ulcerative colitis in cases where other treatments cannot be tolerated or have not worked well and it was in 2018 that the drug was approved for this additional indication.

Possible Side Effects Leading to a Xeljanz Lawsuit

The Xeljanz label warns about a number of serious side effects that may occur during treatment, including hypersensitivity reactions, elevated liver enzymes, lymphoma or other cancers, serious infections, perforations of the intestines or stomach and non-melanoma skin cancers. However, there is another serious and lesser-known side effect that has been linked to the use of Xeljanz – the development of potentially deadly blood clots possibly leading to a venous thromboembolic event (VTE) like pulmonary embolism (PE) or deep vein thrombosis (DVT). People taking Xeljanz for RA, PSA or colitis should be aware of the signs of a VTE.

Symptoms of PE (a blood clot in the lungs):

  • Shortness of breath
  • Sudden difficulty breathing
  • Severe sweating
  • Coughing up blood
  • Clammy skin
  • Bluish-colored skin
  • Chest or back pain

Symptoms of DVT (a blood clot in the deep veins of the body, usually the legs):

  • Warmth in the affected area
  • Swelling in the affected leg
  • Pain in the leg, sometimes like a cramp
  • Discolored skin on the leg

Link Between Xeljanz and Blood Clot Injuries

According to an interim analysis of the results of an ongoing post-marketing safety study involving Xeljanz treatment, RA patients taking a 10mg, twice-daily dose of the drug faced an increased risk of blood clots and death, when compared to patients treated with Xeljanz 5mg, twice-daily and patients treated with a tumor necrosis factor (TNF) inhibitor, another type of drug commonly prescribed to treat RA, PSA and colitis. Blood clots in the lungs or the deep veins of the body can be dangerous or possibly even fatal and RA, PSA or colitis patients who experience such serious side effects while taking Xeljanz may be entitled to compensation for any injuries they suffer.

Xeljanz Lawsuits Over PE, DVT and Other Blood Clot Injuries

The Xeljanz litigation is still in its early stages and claims of serious side effects from Xeljanz are still being investigated. If you or a loved one has taken Xeljanz and you have suffered a blood clot injury like pulmonary embolism or deep vein thrombosis, you should contact an experienced Xeljanz injury lawyer right away to discuss the possibility of filing a Xeljanz lawsuit against Pfizer.

FDA, Xeljanz and Side Effects

November 2012 – The FDA approves Xeljanz but requires that a postmarketing clinical trial be conducted “to evaluate the risk of heart-related events, cancer, and opportunistic infections with the medicine at two doses (10 mg twice daily and 5 mg twice daily) in combination with methotrexate in comparison to another drug called a tumor necrosis factor (TNF) inhibitor.”

April 2013 – The European Medicines Agency declines to approve Xeljanz as a treatment for RA, citing the failure of the five main studies analyzing the safety and effectiveness of the medication to “show a consistent reduction in disease activity and structural damage to joints, particularly at the lower 5-mg dose of Xeljanz and in the target population of patients in whom treatment with at least two other DMARDs has been unsuccessful.” The EMA concludes that the benefits of Xeljanz do not outweigh the potential risks of the medication.

March 2017 – The European Committee for Medicinal Products for Human Use approves Xeljanz as a 5mg, twice-daily treatment for adult patients with moderate to severe RA, to be administered in combination with methotrexate.

February 2019 – The FDA releases a drug safety communication warning about an increased risk of blood clots in the lungs and death in RA patients taking the 10mg, twice-daily dose of Xeljanz. The warning states that the 10mg, twice-daily dose of Xeljanz is only approved for use in patients with ulcerative colitis, not RA.

February 2019 – Pfizer announces that it will begin transitioning patients on the 10mg, twice-daily dosing regimen to the lower 5mg, twice-daily dosing regimen.

March 2019 – Health Canada announces that it will be conducting a safety review of Xeljanz due to problems discovered during the drug’s clinical trial.

March 2019 – Since 2010, the FDA has received reports of 109 cases of PE, including 14 deaths, in patients taking Xeljanz or Xeljanz XR, and 63 cases of DVT, including five deaths.

July 2019 – The FDA approves a new Boxed Warning to be added to the Xeljanz label, highlighting the increased risk of blood clots and death among RA patients taking the higher dose of Xeljanz.

Xeljanz Side Effect Studies

August 2010 – The Proceedings of the Nutrition Society publishes a meta-analysis of studies analyzing the effects of fish oil on RA. According to the research, patients with RA who took a combination of fish oil supplements and non-steroidal anti-inflammatory (NSAID) drugs experienced less joint tenderness.

November 2012 – A small pilot study finds that curcumin treatment relieved joint pain and swelling in patients with active RA.

April 2014 – ScienceDirect publishes a study which finds that RA patients who took the Lactobacillus casei 01 probiotic for eight weeks saw improvements in disease activity and inflammation.

February 2015 – Researchers find that a vegan diet rich in fresh fruits and vegetables, nuts, whole grains, legumes and seeds significantly reduced systemic inflammation in study participants.

March 2015 – The journal Health Technology publishes a study indicating that stretching and performing strengthening exercises can help alleviate symptoms of RA in the hands and wrists.

August 2016 – Researchers find that turmeric extracts and curcumin may be beneficial as a dietary adjunct to conventional therapy for the treatment of arthritis.  

February 2019 – The ongoing clinical trial required by the FDA upon approval of Xeljanz reports that patients treated with Xeljanz 10mg, twice-daily compared to patients treated with Xeljanz 5mg, twice-daily or a TNF inhibitor drug had an increased occurrence of blood clots in the lungs and death.

Why We Think Pfizer Should Be Held Liable for Xeljanz Side Effects

Drug manufacturers like Pfizer are responsible for the safety of their prescription medications and any time there is a risk of patients being harmed by a dangerous or defective drug, it is the responsibility of these drug companies to properly warn patients and the medical community about these potential health risks. When drug makers fail to issue adequate warnings about potentially harmful drug side effects, patients are the ones who pay the price. It is likely that future Xeljanz lawsuits brought against Pfizer will allege that the company:

  • Designed, manufactured and sold a defective medication
  • Failed to adequately research the potential side effects of Xeljanz
  • Failed to provide adequate warnings about the risk of blood clots, DVT, PE and death from Xeljanz treatment
  • Overstated the benefits of Xeljanz for RA, PSA and colitis and downplayed its risks

What should you do? If you have suffered blood clots or another serious side effect, you should contact a lawyer as soon as possible to discuss filing a Xeljanz injury lawsuit.

As more information comes to light about the potential for Xeljanz treatment to cause serious and potentially life-threatening blood clot injuries in users, lawyers across the country are investigating claims on behalf of RA, PSA and colitis patients who believe they were injured by the prescription medication. If you have suffered a venous thromboembolic event like pulmonary embolism or deep vein thrombosis, or if someone you love died from a blood clot injury while taking Xeljanz, don’t wait to seek legal help. Our consumer advocates at Consumer Justice Foundation are committed to helping consumers harmed by dangerous and defective medications and we can help put you in touch with a knowledgeable Xeljanz injury lawyer today.

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