The FDA approved Xeljanz® and Xeljanz XR® (generically known as tofacitinib) in 2012 to treat rheumatoid arthritis (RA); the FDA later approved for treatment of psoriatic arthritis (PSA), ulcerative colitis (UC) and juvenile idiopathic arthritis (JIA). However, questions about the drug’s safety were raised after an FDA required clinical trial found elevated risks of severe side effects including blood clots, heart problems, cancer and even death.
Currently the 5mg tablet once or twice daily is approved for rheumatoid arthritis, but a 10mg twice daily dose is approved for moderate to severe ulcerative colitis.
The FDA required a boxed warning, the agency’s most prominent warning, for Xeljanz warning of the potential for deadly effects. On Sept. 1, 2021, the FDA announced that it was revising a previous warning and that it includes two additional drugs, Olumiant® and RinvoqTM, which share a mechanism of action with Xeljanz and are also required to include the new boxed warning
Contact a medical drug attorney
If you developed blood clots, a serious heart related problem, or cancer after taking Xeljanz, Olumiant or Rinvoq, or if a loved one died from one of these diagnoses or related complications caused by the drug, you may reach medical drug attorneys Kimberly Barone Baden or Ann E. Rice Ervin by email or call 1.800.768.4026 for more information or to discuss a potential claim.
If you believe you have a claim, contact an attorney as soon as possible. A statute of limitations (SOL) may limit the time you have to file a claim. If you do not file your claim within the SOL, you may lose it forever.
Xeljanz, Olumiant, Rinvoq (JAK Inhibitors) side effects
Potential complications of Xeljanz, Olumiant and Rinvoq include:
- Blood clots, such as a pulmonary embolism (PE) or a deep vein thrombosis (DVT)
- Serious heart-related problems, such as a heart attack or stroke
- Cancer, including blood cancers such as lymphoma or lung cancer
Xeljanz boxed warning background
In 2019, interim results of a required post-marketing safety study conducted by Pfizer, Study ID Number A3921133, showed an increased risk of blood clots and death with the higher 10mg twice daily dosage. As a result of this safety study, the FDA approved the addition of boxed warnings for blood clots and death on the drug’s label in July 2019.
The FDA then alerted the public in February 2021 that preliminary results from a safety clinical trial also showed an increase risk of serious heart related problems and cancer compared to another type of medicine. Further studies of the drug’s effects are ongoing.
Our medical drug litigation experience
Motley Rice medical attorneys have experience litigating for patients alleging they were hurt by dangerous prescription and over-the-counter drugs, and our attorneys hold leadership roles in multiple medical drug and device cases.
We understand that as a patient or family member, what you know about the medicines you or your loved one take and the health risks of the medicine may be limited. If you believe a medicine made you sick or hurt you, our attorneys have the resources needed to thoroughly investigate and:
- Identify potentially harmful medicines,
- Determine if the medicine hurt you,
- Review the medicine manufacturer’s compliance with FDA regulations,
- Confirm if the manufacturer adequately warned you about potential side effects,
- Identify anything the manufacturer did wrong or illegal concerning your medicine, and
- Recognize other issues that could affect your potential claim.
Do not stop taking a prescribed medication without first consulting with your doctor. Discontinuing a prescribed medication without your doctor's advice can result in injury or death.