Xeljanz Lawyers Review Cases Nationwide
Xeljanz (tofacitinib) is the first member of a new class of drugs, which has been approved for treatment of rheumatoid arthritis, psoriatic arthritis and ulcerative colitis. However, it now appears that the drug maker failed to adequately warn about the increased the risk of dangerous and potentially life-threatening blood clots in the lungs and other injuries.
The Xeljanz lawyers at Saiontz & Kirk, P.A. provide free consultations and claim evaluations to help individuals and families determine whether financial compensation may be available. All cases are pursued on a contingency fee basis, which means that there are never any out-of-pocket costs to hire a lawyer, and our attorneys only receive a fee or expenses if a settlement or recovery is obtained.
To learn more and find out whether you or a loved one may have a Xeljanz case, call 1-800-522-0102 or request a free case review.
Problems with Xeljaz/Xeljanz XR
Xeljanz and Xeljanz XR are part of a new class of rheumatoid arthritis drugs, known as Janus kinase (JAK) inhibitors, which work in a unique way deep inside the cell to disrupt cellular activities.
The drug was first introduced in 2012, as a second-line treatment for adults with severe rheumatoid arthritis. Approval was expanded to include treatment of active psoriatic arthritis (PsA) in 2017 and for treatment of ulcerative colitis in 2018.
Amid aggressive marketing by Pfizer, Xeljanz has quickly grown to become a “blockbuster” treatment, generating over $1 billion in annual sales. However, it appears that the drug maker knew or should have known about the link between Xeljanz and pulmonary embolism, yet failed to provide adequate warnings for users and the medical community.
Xeljanz Blood Clot Risk
Xeljanz is typically taken at a dose of either 5mg or 10mg twice daily. Although the higher dose has not been established as safe and effective for treatment of rheumatoid arthritis, many doctors have prescribed that double dose of Xeljanz since the manufacturer failed to disclose the potential blood clot side effects.
As part of the approval process, the FDA required Pfizer to conduct a post-marketing study, known as A3921133, which was designed to assess the risk of cardiovascular events. However, the early results from this Xeljanz study found that at higher doses users were more experience a blood clot the lungs, known as a pulmonary embolism, or wrongful death.
In February 2019, the FDA issued a Drug Safety Communication, providing the first public information about the potential Xeljanz pulmonary embolism risk.
According to preliminary findings of this study, comparing use of 10mg Xeljanz twice daily for rheumatoid arthritis to use of 5mg tablets twice daily and use of other rheumatoid arthritis drugs (Humira, Enbrel and other TNF inhibitors), researchers found:
- 5x higher risk of pulmonary embolism with higher dose of Xeljanz compared to TNF Inhibitors
- 3x higher risk of pulmonary embolism with 10mg dose when compared to 5mg Xeljanz for rheumatoid arthritis
- Higher risk of death from all causes with Xeljanz 10mg twice daily dose
In July 2019, the FDA announced that Pfizer was required to add a Xeljanz black box warning about the risk of blood clots and death among users of the higher dose. Users are now advised to seek immediate medical attention if they experience signs or symptoms of pulmonary embolism, and federal health officials are recommending that doctors closely monitor patients prescribed Xeljanz.
If earlier warnings and information about the Xeljanz blood clot risk had been provided by Pfizer, many individuals nationwide may have avoided a serious or fatal pulmonary embolism, deep vein thrombosis, stroke or other life-threatening injuries.
Timeline of Xeljanz Case
FDA approves Xeljanz for treatment of adults with rheumatoid arthritis.
Xeljanz sales rapidly grow to generate a new “blockbuster” drug for Pfizer, reaching $927 million in sales by 2016.
Expanded approval for treatment of active psoriatic arthritis (PsA).
Expanded approval for treatment of moderate to severe active ulcerative colitis.
Feb 19, 2019
Pfizer announces preliminary results of Study A3921133, which was required by FDA to evaluate heart risks.
Feb 25, 2019
FDA Safety Communication warns about risk of blood clots in the lungs when 10mg twice daily dose of Xeljanz used with rheumatoid arthritis.
March 2, 2019
European Medicines Agency (EMA) warns that overall incidence of pulmonary embolism with Xeljanz was 5-fold higher with 10mg twice daily dose, compared to other rheumatoid arthritis drugs.
July 26, 2019
The FDA required a new “Boxed Warning” for Xeljanz, which is the strongest label information a drug maker can be required to add.
- Sudden shortness of breath
- Chest pain
- Upper back pain
- Difficulty breathing
- Coughing up blood
- Excessive Sweating
- Clammy or blue colored skin
(Do not stop taking any drug or change dose without first speaking with your doctor)
Allegations Raised in Xeljanz Class Action Lawsuits
Pfizer had a duty to warn fully research their new-generation drug, and warn about potential Xeljanz risks, so that consumers and doctors could make an informed decision about whether to use the drug. According to allegations that will be raised in Xeljanz blood clot lawsuits, the pharmaceutical company has:
- Failed to properly research the Xeljanz side effects before introducing the drug;
- Failed to promptly follow through on studies to investigate the potential Xeljanz cardiovascular risks;
- Failed to disclose reports of pulmonary embolism, deep vein thrombosis, stroke and other blood clots on Xeljanz;
- Failed to provide accurate Xeljanz warnings for consumers and the medical community;
- Failed to issue a Xeljanz recall or safety warnings about the risks users face at certain doses;
No Fees or Expenses Unless You Receive a Xeljanz Settlement
Saiontz & Kirk, P.A. is a nationally known injury law firm that is focused exclusively on representing individuals, we do not represent corporations or insurance companies.
Over the course of more than 40 years, clients of our law firm have collected more than $1 billion in compensation in cases involving product liability, medical malpractice, automobile accidents and other personal injury lawsuits.
All Xeljanz injury lawsuits will be handled by our attorneys on a contingency fee basis, which means that there are never any out-of-pocket expenses to hire our law firm and we only receive an attorney fee if we secure compensation for our client.
Protect your family and find out if you or a loved one may be eligible for an Xeljanz settlement.