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What to Know?
There has been a lot of buzz circulating lately about serious health risks associated with the popular arthritis medication Xeljanz (tofacitinib) and about patients potentially filing lawsuits as a result. Sometimes, this kind of information overload can unfortunately raise more questions than it answers.
To help make sense of it all, TheLawFirm.com has put together this primer summarizing the problems with Xeljanz and describing what factors are at play in determining who might qualify to bring a lawsuit against Xeljanz-maker Pfizer.
The Problems with Xeljanz
Dating back to 2019, the United States Food and Drug Administration (FDA) has issued a series of increasingly urgent warnings regarding the drug Xeljanz (tofacitinib), culminating in a February 2021 Drug Safety Communication announcing that preliminary results from a mandatory safety trial had found an increased risk of both serious heart-related problems and cancer in those taking Xeljanz.
“The FDA is alerting the public that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with the arthritis and ulcerative colitis medicine Xeljanz,” the safety communication said.
The announcement followed a previous communications in February 2019 warning that the same study had found an increased risk of blood clots in the lungs and death in those taking Xeljanz.
Following the February announcement, in July 2019, the FDA announced that it had approved the use of its “most prominent Boxed Warning, after reviewing interim data from an ongoing safety clinical trial of tofacitinib in patients with rheumatoid arthritis.” The use of the agency’s most prominent warning indicates the high level of seriousness the FDA ascribed to the health risks posed by Xeljanz.
Further, the FDA at that time took steps to curb the use of Xeljanz for the treatment of ulcerative colitis except in limited circumstances, given the risks.
“In addition, the approved use of tofacitinib for ulcerative colitis will be limited to certain patients who are not treated effectively or who experience severe side effects with certain other medicines,” the FDA’s July 26 announcement stated.
What is Xeljanz?
Developed by pharmaceutical giant Pfizer in conjunction with the National Institutes of Health (NIH), tofacitinib first was investigated as a means of suppressing the immune system in order to prevent a patient’s body from rejecting a donated kidney.
However, in the course of the research, it was demonstrated that Xeljanz—then known simply as tofacitinib—also had a beneficial impact on those experiencing rheumatoid arthritis, particularly those for whom other treatments had proven ineffective.
Based on these promising results, Xeljanz initially was approved by the US FDA in 2012. However, the drug was rejected by the European Union’s regulatory authority the following year, with the EU’s Committee for Medicinal Products for Human Use (CHPM) concluding that the data submitted by Pfizer did not sufficiently demonstrate a consistent benefit from Xeljanz. Additionally, the CHPM expressed concerns over the drug’s safety.
Undeterred, Pfizer reapplied, and ultimately Xeljanz—in combination with methotrexate (MTX)—was approved in 2017 for use in Europe as a treatment for moderate or severe active rheumatoid arthritis. In 2018, the combination was approved for the treatment of active psoriatic arthritis, and, that same year, the CHPM approved Xeljanz with MTX for the treatment of ulcerative colitis, as well.
(By comparison, Xeljanz was approved in the US in 2012 for the treatment of rheumatoid arthritis in adults. In 2017, the approval was extended to include the treatment of psoriatic arthritis, which also is a condition characterized by joint pain and swelling. In 2018, the US FDA approved Xeljanz as a treatment for ulcerative colitis.)
Xeljanz Lawsuits – Who Qualifies?
As scientific evidence continues to mount about the very serious—and potentially deadly—side effects of Xeljanz, patients and the representatives of deceased loved ones are exploring using the legal system as a means of pursuing justice.
Similarly, lawyers who represent the victims of dangerous pharmaceuticals and defective medical devices have been investigating Xeljanz and have begun to develop questionnaires or intake forms that will help them to determine the strength of a potential client’s case.
Questions that lawyers are likely to ask when considering whether or not to take on a Xeljanz case cover everything from the potential client’s level of exposure to Xeljanz to the specific physical ailments he or she blames on Xeljanz. For example, attorneys are likely to ask how long the patient took Xeljanz for, how many times per day it was taken, and what the dosage was.
Additionally, an attorney likely will ask whether a potential client has been diagnosed with one of the three categories of serious side effects associated with Xeljanz: blood clots, cardiovascular events (cardiac arrest, heart failure, ischemic stroke), or cancer.
If so, the attorney likely will want to know more about the nature of the condition, its seriousness and duration, and whether or not the potential client was ever hospitalized as a result. While it can sometimes feel uncomfortable to share detailed medical information with someone who is not your doctor or a close loved one, it is necessary for your lawyer to have as much information about your case as possible, so as to gauge its strengths and weaknesses.
If you or a loved one has suffered from blood clots, heart attack, heart failure, stroke, or cancer after taking Xeljanz, contact TheLawFirm.com today for a free legal consultation!
United States Food and Drug Administration (FDA). (4 February 2021). Xeljanz, Xeljanz XR (tofacitinib): Drug Safety Communication – Initial Safety Trial Results Find Increased Risk of Serious Heart-related Problems and Cancer with Arthritis and Ulcerative Colitis Medicine
United States Food and Drug Administration (FDA). (25 February 2019). Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanx XR) in rheumatoid arthritis patients; FDA to investigate
United States Food and Drug Administration (FDA). (26 July 2019). FDA approves Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR)
Medical News Today. (25 April 2013). Pfizer’s Arthritis Drug Xeljanz (tofacitinib) Receives A Negative Opinion In Europe.
Pfizer. (1 August 2018). Xeljanx (tofacitinib citrate) receives marketing authorization in the European Union for moderately to severely active ulcerative colitis. Press Release
LaMattina, John. (10 May 2012). A Brief History of Tofacitinib. Forbes