The FDA approved Xeljanz® and Xeljanz XR® (generically known as tofacitinib) in 2012 to treat rheumatoid arthritis (RA), psoriatic arthritis (PSA), and ulcerative colitis (UC). However, questions about the drug’s safety recently came to light after a clinical trial found elevated risks of severe side effects in people who took a 10 mg dosage twice a day, including deadly blood clots, heart problems and cancer.
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.
Contact a Xeljanz attorney
If you developed blood clots, a serious heart related problem, or cancer after taking Xeljanz, or if a loved one died from complications caused by the drug, you may reach medical drug attorney 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 side effects
Potential complications of Xeljanz 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
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.
Always consult a medical professional before stopping or changing any medication.