Xeljanz (tofacitinib) is a medication prescribed to treat rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. The Food and Drug Administration (FDA) recently issued a safety communication warning that the initial results of a safety clinical trial found an increased risk of heart-related problems and cancer in patients taking Xeljanz.
If you or a loved one has suffered a heart-related injury or been diagnosed with cancer after taking Xeljanz, contact our Defective Drug Lawyers today to discuss your potential Xeljanz lawsuit. Our team has over 35 years of experience representing victims harmed by the manufacturers of dangerous drugs. Allow us to deliver the Gold standard of advocacy you deserve for your potential Xeljanz lawsuit.
Case Quick Facts
On February 4, 2021, the FDA alerted the public that initial results from a safety clinical trial show that rheumatoid arthritis patients taking Xeljanz were at higher risk of heart-related problems and cancer than patients taking another type of medication used to treat rheumatoid arthritis. The trial compared patients taking the 5 mg and 10 mg twice daily doses of Xeljanz to patients taking a tumor necrosis factor (TNF) inhibitor. Patients participating in the trial were over age 50 and had at least one cardiovascular risk factor. The trial did not include patients taking Xeljanz for ulcerative colitis or psoriatic arthritis.
The initial results found a higher incidence of serious heart issues and cancer in patients taking Xeljanz compared to patients taking the TNF inhibitor. Full results from the trial are not yet available. The FDA is recommending that patients continue taking Xeljanz as prescribed and consult their healthcare providers with questions or concerns. The agency has asked patients and healthcare providers to report side effects involving Xelajnz to its MedWatch program.
In July 2019, the FDA issued a Black Box Warning for Xeljanz after the ongoing safety clinical trial showed an increased risk of blood clots and death in patients taking the 10 mg twice daily dose compared to patients taking the 5 mg twice daily dose or a TNF inhibitor. At that time, patients taking the 10 mg dose in the trial were switched to the 5 mg dose.
The FDA’s safety clinical trial found an increased risk of serious heart-related problems and cancer in patients taking Xeljanz to treat rheumatoid arthritis. Injuries that may be linked to Xeljanz include:
- Heart Attacks
- Pulmonary Embolisms
Xeljanz was approved by the FDA in 2012 to treat adults with rheumatoid arthritis who did not have success treating with methotrexate. The medication was later approved for the treatment of psoriatic arthritis in 2017 and ulcerative colitis in 2018. Xeljanz is manufactured by Pfizer, Inc. and is approved for use in treating rheumatoid arthritis in over 80 countries.
GoldenbergLaw Can Help
GoldenbergLaw is currently investigating potential Xeljanz lawsuit cases where an individual has taken Xeljanz and suffered a heart-related injury or been diagnosed with cancer. We have successfully represented the victims of defective pharmaceutical drugs for over 35 years. Contact us today for a free Xeljanz lawsuit consultation, and leave the sleepless nights to us.
A Personal Message From Senior Partner Stuart Goldenberg
Every pharmaceutical manufacturer has the duty to fully investigate any safety concerns and potential side effects prior to releasing a new medication to the market. Sadly, the results of the FDA’s safety clinical trial show that Pfizer failed in its duty to ensure Xeljanz is safe. Thousands of consumers have been relying on Xeljanz to treat complicated and painful illnesses. The trial’s results found those consumers may be at a higher risk of deadly heart-related injuries and cancer. Those consumers deserve justice. GoldenbergLaw has been holding corporations like Pfizer responsible for injuries resulting from defective medications for over 35 years. Call us today.
If you or a loved one has suffered a heart-related injury or has been diagnosed with cancer after taking Xeljanz, contact GoldenbergLaw today. Our team of Defective Pharmaceutical Lawyers has successfully helped thousands of clients around the country harmed by defective medications obtain the compensation they deserved. Let us deliver the Gold standard of advocacy you deserve by investigating your potential Xeljanz lawsuit. Call us today for a free Xeljanz lawsuit consultation.
Xeljanz FDA Safety Clinical Trial Timeline
- February 25, 2019: The FDA issues a statement alerting the public that an ongoing safety clinical trial found an increase in blood clots in the lungs and an increase in death in patients taking the 10 mg twice daily dose of Xeljanz. The agency’s statement advises patients taking Xeljanz to be alert for symptoms of blood clots in the lungs and recommended patients to continue taking Xeljanz until they consult their healthcare provider.
- July 26, 2019: The FDA issues a Black Box Warning for the 10 mg twice daily dose of Xeljanz, citing an increased risk of blood clots in the lungs and death. The warning limits the use of Xeljanz in treating ulcerative colitis to patients who are not treated effectively with other medications. As a result of this warning, the FDA discontinues the evaluation of the 10 mg twice daily dose of Xeljanz in its ongoing safety clinical trial and switches participants taking the 10 mg dose to the 5 mg dose.
- February 4, 2021: The FDA announces that initial results of its safety clinical trial show that patients taking Xeljanz are at a higher risk of heart-related problems and cancer than patients taking a TNF inhibitor. The announcement states that final results of the trial are not yet available, but adds that the agency will evaluate the results and communicate final conclusions once its evaluation is complete. The agency recommends patients currently taking Xeljanz consult their healthcare provider with any questions or concerns.
How Do Xeljanz and Xeljanz XR Work?
Xeljanz is the brand name drug manufactured by Pfizer to treat rheumatoid arthritis. It is made from the active ingredient tofacitinib and was approved by the U.S. Food and Drug Administration (FDA) to treat rheumatoid arthritis in November 2012, psoriatic arthritis in December 2017, and ulcerative colitis in May 2018. Xeljanz XR is the extended-release version of the medication.
Xeljanz and Xeljanz XR work by slowing down Janus kinase (JAK) enzymes. These enzymes are responsible for DNA transcription which triggers cell growth. If there are problems in this process, unwanted tissue growth in the joints can occur. The tissue can then harm the bone structure and cartilage that are immensely important for joint function, and the extra tissue can cause inflammation and pain which is compounded when the body’s immune system attacks the tissue. The result of this inflammation and pain is rheumatoid arthritis.
Xeljanz is intended to slow down JAK enzymes thereby preventing this chain of events and treating rheumatoid arthritis.
Xeljanz Dosing and Administration
Xeljanz is mostly commonly administered orally, in pill form.
Two Types of Xeljanz Medication:
- Xeljanz– the standard medication that comes in 5 mg and 10 mg doses
- Xeljanz XR– the extended release version of Xeljanz which comes in 11 mg pills that delay the release of the medication throughout the day
On July 26, 2019, the U.S. Food and Drug Administration (FDA) announced a Black Box Warning for Xeljanz 10 mg twice daily due to the increased risk of blood clots and death. As a result, the FDA recommended that Xeljanz be reserved for patients with ulcerative colitis whose condition is not being effectively treated with tumor necrosis factor (TNF) blockers.
The FDA instructed patients to not stop taking Xeljanz without discussing it with their medical provider. Healthcare providers were advised to weigh the risks and benefits when deciding whether to prescribe or continuing patients on Xeljanz.
The current Xeljanz recommendations are based on preliminary results from a clinical study; the final results have yet to be released. The FDA said that it is working with Xeljanz’s manufacturer, Pfizer, to review the final results as they become available.
Serious complications from Xeljanz can include:
Xeljanz Lawsuit FAQs
Do I Have A Xeljanz Lawsuit?
If you or a loved one has taken Xeljanz and been diagnosed with a heart-related injury or cancer, you may have a case against the manufacturers. Contact GoldenbergLaw today for a free case evaluation.
Should I Continue Taking Xeljanz?
The FDA recommends that patients currently taking Xeljanz speak with their healthcare providers before making any changes. The agency warns that patients who stop taking Xeljanz without first consulting their providers may worsen their condition.
What Did The FDA's Safety Clinical Trial of Xeljanz Find?
The FDA’s safety clinical trial of Xeljanz recently concluded. Initial results show that patients taking Xeljanz are at a higher risk of experiencing heart-related problems or developing cancer than patients taking a TNF inhibitor. Final results of the study have not been released. The FDA has announced it will communicate its final recommendations once it has completed its review of the study.
What Compensation Am I Entitled To In A Xeljanz Lawsuit?
If you or a loved one has been diagnosed with cancer or a heart-related injury after taking Xeljanz, you may be entitled to compensation for your injuries. Contact GoldenbergLaw for a free Xeljanz lawsuit consultation and to learn more about the Xeljanz litigation.
Why Choose GoldenbergLaw?
Our team of Xeljanz attorneys has the experience and expertise required to successfully litigate your claim. We have over 35 years of experience representing victims harmed by defective medications like Xeljanz, let us deliver the Gold standard of advocacy you deserve.