Xeljanz Lawsuit

People taking Xeljanz may face an increased risk for pulmonary embolism, heart problems, cancer, and even death. Filing a Xeljanz lawsuit could be the only possible avenue for victims of such side effects to obtain compensation for their injury-related damages.

Contact Our Attorneys for a Free Xeljanz Lawsuit Review

The defective drug attorneys at Bernstein Liebhard LLP are now offering free, no-obligation legal reviews to victims of possible Xeljanz side effects, including:

  • Pulmonary embolism (PE)
  • Deep vein thrombosis (DVT blood clot)
  • Heart attack
  • Stroke
  • Other heart-related adverse events
  • Cardiovascular death
  • Cancer

To contact our office for more information about filing a Xeljanz lawsuit, please call (888) 994-5118 today.

What is Xeljanz?

The U.S. Food & Drug Administration (FDA) approved xeljanz lawsuitXeljanz  (tofacitinib)  in 2012. However, the agency only cleared the drug for patients with moderate to severe active RA who had not responded to methotrexate.

The FDA subsequently approved Xeljanz XR in 2016. Eventually, the agency would also expand tofacitinib’s approved indications to include the treatment of psoriatic arthritis and ulcerative colitis.

European regulators refused to approve Xeljanz for RA in 2013 due to its potential to cause serious, opportunistic infections. Two years later, the FDA rejected Xeljanz as a treatment for moderate to severe plaque psoriasis.

Xeljanz Pulmonary Embolism and Death

When the FDA first approved Xeljanz, it ordered Pfizer to study the risk of heart-related events, cancer, and opportunistic infections at two doses (10 mg twice daily and 5 mg twice daily) in combination with methotrexate. Subsequently, the company launched a post-marketing trial involving RA patients over the age of 50 treated with either:

  • 10 mg twice-daily dose of Xeljanz (only approved for ulcerative colitis)
  • 5 mg twice-daily dose of Xeljanz
  • Another class of RA medication called TNF inhibitors

In February 2019, the FDA disclosed that the trial’s most recent analysis suggested Xeljanz patients taking the 10 mg twice-daily dose were more likely to suffer pulmonary embolism (a blood clots in their lungs) or die compared to either those taking the lower dose or TNF inhibitors.

In July of that year, the FDA ordered Pfizer to update the Xeljanz Black Box Warning to reflect the risk of pulmonary embolism and death associated with the 10 mg twice-daily dose.  The agency also limited the approved use of this dosage regimen to ulcerative colitis patients who are not treated effectively or who experience severe side effects with certain other medicines.  According to the FDA, health care providers should prescribe the lowest effective dose possible and limit the 10mg twice-daily regimen to the shortest duration possible.

Patients taking Xeljanz should not stop using the medication without first talking with their doctor. They should, however, seek immediate medical attention for any unusual symptoms that could be indicative of a pulmonary embolism, including:

  • Sudden shortness of breath or difficulty breathing
  • Chest pain or pain in your back
  • Coughing up blood
  • Excessive sweating
  • Clammy or bluish-colored skin

FDA Investigating Xeljanz-Related Heart Problems and Cancer

The FDA launched another Xeljanz review after initial findings from the same trial indicated a higher occurrence of serious heart-related events and cancer in rheumatoid arthritis patients treated with both the 5mg and 10mg doses of Xeljanz compared to patients treated with a TNF inhibitor.

“We will evaluate the clinical trial results we have received to date and will work with the drug manufacturer to obtain further information as soon as possible,” the FDA said in a communication issued on February 4, 2021. “We will communicate our final conclusions and recommendations when we have completed our review or have more information to share.”

For now, health care providers are advised to consider the benefits and risks when deciding whether to prescribe Xeljanz or continue treating patients with methotrexate. Subsequently medicine.

How Filing a Xeljanz Lawsuit Can Help

Filing a lawsuit against Pfizer may be the only way victims of alleged Xeljanz side effects can recover  compensation for their physical, financial, and emotional damages, such as:

  • Past and future medical bills
  • Past and future lost wages
  • Pain and suffering
  • Emotional distress
  • Disability

Additionally, a Xeljanz lawsuit may  allow surviving loved ones to recover compensation for:

  • Wrongful death
  • Funeral expenses
  • Mental anguish
  • More

However, to win a case, potential plaintiffs must prove that  Pfizer knew (or should have known) that tofacitinib was unreasonably dangerous and failed to provide patients with adequate safety warnings.

Obviously, pursuing a Xeljanz lawsuit is a complex undertaking. If you want to succeed, you need the assistance of product liability attorneys with extensive experience litigating drug injury claims.

Legal Help for Alleged Victims of Xeljanz

Bernstein Liebhard LLP has successfully represented hundreds of people seriously injured by dangerous drugs and medical devices.

If you are interested in filing a Xeljanz lawsuit, our Firm will represent you on a contingency basis. This means your legal fees will be deducted from any judgment our attorneys win on your behalf or any settlement we negotiate with Pfizer.  However, you’ll owe absolutely nothing if your lawsuit is not successful.

All consultations are free, and you won’t be obligated to retain our Firm if you speak with a member of our legal team. To learn more about filing a Xeljanz lawsuit, simply call our office today at (888) 994-5118.

  1. Pfizer, Inc. (June 2015) “Xeljanz Prescribing Information” http://labeling.pfizer.com/ShowLabeling.aspx?id=959
  2. EMA (July 2013) “Refusal of the marketing authorisation for Xeljanz (tofacitinib)” http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/002542/WC500146629.pdf
  3. Reuters (October 2015) “FDA declines to expand approval of Pfizer arthritis drug” http://www.reuters.com/article/2015/10/14/pfizer-psoriasis-fda-idUSL1N12E2OW20151014 
  4. FDA (February 2019) “Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigate.”  https://www.fda.gov/Drugs/DrugSafety/ucm631871.htm
  5. FDA (July 2019) “Xeljanz, Xeljanz XR (tofacitinib): Drug Safety Communication – Due to an Increased Risk of Blood Clots and Death with Higher Dose.” https://www.fda.gov/safety/medical-product-safety-information/xeljanz-xeljanz-xr-tofacitinib-drug-safety-communication-due-increased-risk-blood-clots-and-death
  6. FDA (February 2021) “Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)” https://www.fda.gov/drugs/drug-safety-and-availability/initial-safety-trial-results-find-increased-risk-serious-heart-related-problems-and-cancer-arthritis
Last Modified: April 13, 2021

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