The Firm You Go to When the 
Stakes Are High

FDA Warns of New Dangers Associated with JAK Inhibitors

The Food and Drug Administration (FDA) has published new warnings about several medications for the treatment of arthritis and other inflammatory conditions. These medications, known as Janus kinase (JAK) inhibitors, are used to suppress an over-reactive immune system to reduce joint pain and swelling and prevent long term damage to joints. JAK inhibitors belong to a class of medications known as DMARDs, or disease-modifying antirheumatic drugs. The FDA granted approval to three medications for the treatment of rheumatoid arthritis: baricitinib (Olumiant), tofacitinib (Xeljanz) and upadacitinib (Rinvoq).

New Warnings Following Results of Safety Clinical Trial for Xeljanz and Xeljanz XR

LK previously alerted readers to warnings issued by the FDA concerning Xeljanz and Xeljanz XR (tofacitinib), which are used to treat rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. In February, 2019, the FDA reported that there is an increased risk of blood clots and death in patients who are taking Xeljanz for the treatment of rheumatoid arthritis. The FDA then issued another alert in February, 2021 to inform patients that preliminary results of a clinical trial indicated that serious heart conditions and cancer are associated with the use of Xeljanz.

Now the FDA has published the results of a large randomized safety clinical trial and concluded that Xeljanz and Xeljanz XR pose an increased risk of serious cardiovascular conditions. This may include heart attack, stroke, cancer, blood clots, and death. In its clinical trial, the FDA reviewed the side effects and complications of Xeljanz and Xeljanz XR as compared to another medication for the treatment of rheumatoid arthritis known as tumor necrosis factor (TNF) blockers. In addition, lower doses of Xeljanz were linked to an increased risks of blood clots and death contrary to previous results showing that serious conditions and death were associated only with higher doses of the medication.

Updated Warnings Also Required for Two Other JAK Inhibitor Drugs

The FDA also notified the public about updated warnings for two other JAK inhibitors that belong to the same class of drugs as Xeljanz. These medications- Olumiant and Rinvoq- may present similar health risks as Xeljanz, although they have not been evaluated in large scale clinical trials. Because these JAK inhibitors work in the same way as Xeljanz, patients are warned that they may also have an increased risk of serious cardiovascular conditions. Finally, two other JAK inhibitors- Jakafi and Inrebic- were not included in the FDA warning since they are not used for the treatment of arthritis and other inflammatory diseases.

Contact our lawyers to review whether you or a family member may be entitled to financial compensation as a result of serious health conditions associated with taking JAK inhibitors. Levy Konigsberg LLP is currently accepting cases in all 50 states.

If you or a loved one has suffered complications from Xeljanz or other JAK inhibitors, you may be entitled to a cash award and compensation for medical expenses. For a free confidential consultation with lawyers at our law firm, please call (800) 315-3806 or submit an email inquiry.


Find out whether you have a case by speaking to one of our experienced lawyers via our 24/7 toll-free hotline or by submitting an email inquiry. Our attorneys will be quick to respond to you and happy to answer all of your questions.

Know the Difference

Committed to Doing What's Right
  • Over $3 Billion Won

    We have represented numerous individuals and groups of workers, winning for them multi-million-dollar settlements and verdicts.

  • There's No Case Too Big

    Our team has achieved groundbreaking victories in highly complex cases and has gone up against some of the toughest defendants in the country.

  • Trial Attorneys

    Our attorneys excel in the courtroom and are not afraid to bring a case in front of a jury if a fair settlement for the client has not been reached.

  • A Thought Leader in the Industry

    Our firm's knowledge and experience are in high demand, and many news outlets have asked us to share our legal expertise.

  • Access to World Class Resources

    Our experienced attorneys use cutting-edge technology and highly regarded experts to help us achieve the best possible result for our clients.

  • Changing the World for Good

    We not only want to achieve the best possible results for our clients, but we also strive to prevent future harm by changing public health policies.

Thousands of Clients Helped

Hear What They Have to Say
  • Professional, responsive and very good at their jobs.

    “From the first visit to my home, to my last visit to the office to collect my settlement, I was very happy with the services provided by this firm. They are professional, very responsive and very good ...”

    - Lisa Ross
  • They have truly gone above and beyond.

    “I have been beyond pleased how Levy Konigsberg is handling my matter. They answer my questions in a timely matter and when warranted, ease my worries and concerns. They have truly gone above and ...”

    - Anne Fahey
  • I put my Faith and Trust into Corey Stern!

    “Selecting a Law firm to represent me was one of the biggest decisions I've had to make in my life. I put my Faith and Trust into Corey Stern, and he exceeded all my expectations.”

    - Dennis McGowan
  • With this team on my side we came out on top.

    “Levy Konigsberg and team are a group of men and women that give their all, down to the receptionist. I had a case that was almost unbeatable but with this team on my side we came out on top. They keep ...”

    - Angie Garrido
  • Very happy with our settlement.

    “My husband and I were VERY happy with our experience with this firm. They were always caring and really helped us go through this in a very hard time in our lives .We continue to be in touch with the ...”

    - Lori Rosa
  • Wow is all I can say.

    “It has been a few years now but I needed to post this. My dad suffered so much from Mesothelioma. My brother looked into the law and our rights. Unfortunately he died also before anything was done. It ...”

    - Carol N.
  • Their dedication to receive the highest results for their clients was amazing.

    “Working with Levy Koningsberg LLP was a very positive experience. Their professionalism and curiosity was outstanding. I was a pleasure working with this firm. Their dedication to receive the highest ...”

    - Emily DeRogatis
  • Such a great team!

    “The whole team at Levy, Konigsberg LLP have been extremely professional and kind during our most difficult time. They keep you informed during the process, check in often asking if there are any ...”

    - Kevin Kober
  • We definitely got the right law firm!

    “Levy Konigsberg represented my daughter Linda, who was diagnosed with mesothelioma at 16 years old. She endured many surgeries and chemotherapy including HIPEC. She traveled the country seeking ...”

    - Mark Wells
  • Levy Konigsberg continued to help my family fight for the justice my father deserves.

    “Levy Konigsberg was there for my father as soon as he was diagnosed with mesothelioma they helped him get medical treatment in another state that specializes in his condition and even provided housing ...”

    - Stephanie Vitale


Start with a FREE Consultation
  • Please enter your first name.
  • Please enter your last name.
  • Please enter your phone number.
    This isn't a valid phone number.
  • Please enter your email address.
    This isn't a valid email address.
  • Please make a selection.
  • Please enter a message.