Xeljanz is a drug manufactured by Pfizer to treat rheumatoid arthritis. In 2019, the U.S. Food and Drug Administration warned the public about an increased risk of pulmonary embolism and death in patients taking Xeljanz and Xeljanz XR in higher than 10mg doses. Due to this risk of potentially fatal blood clots in the lungs, the FDA does NOT approve a 10mg dose of Xeljanz for rheumatoid arthritis patients.


Patients who developed blood clots and other related injuries, such as deep vein thrombosis and pulmonary embolism, while taking Xeljanz have sued Pfizer claiming that the drugmaker was negligent in failing to warn them of the risks.


Showard Law Firm is currently investigating cases of patients who took Xeljanz at 5mg or 10mg dose and suffered serious complications, including death, as a result of the drug’s proven dangerous side effects. The number of Xeljanz lawsuits being filed across the country continues to grow, with plaintiffs seeking damages for medical expenses related to their injuries, as well as compensation to cover lost wages at work and diminished quality of life. In some cases, plaintiffs may seek punitive damages against Pfizer, to send a loud and clear message to the drug manufacturer that putting profits over patient safety will come at great cost to its bottom line.


If you or a loved one have been hurt from Xeljanz, you may be entitled to substantial financial compensation. The statute of limitations in your state governs how long you have to file a lawsuit, so please contact Showard Law Firm today to discuss your legal options and to see if filing a lawsuit is the right next step for you and your family. All initial case reviews are free of charge, and you will owe no fees whatsoever unless damages are recovered on your behalf.


Xeljanz Side Effects


Xeljanz (tofacitinib) is commonly prescribed for the treatment of rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. This orally-administered class of drugs is known as Janus Kinase Inhibitors, which decrease immune system activity. According to RX List, 4% of Xeljanz patients discontinue the drug due to side effects.


The most problematic Xeljanz side effects include:


Xeljanz Blood Clots

When blood changes from a liquid to a semi-solid gel, it can prevent you from losing too much blood after an injury. However, when a clot forms inside a vein and won’t dissolve on its own, it can obstruct vital blood flow to and from the heart, which can lead to sudden death.


Xeljanz Deep Vein Thrombosis

When a blood clot forms in a deep vein of the thigh or lower leg, blocking blood flow, it is called deep vein thrombosis. If the deep vein thrombosis breaks loose, it can cause a pulmonary embolism. From 2012 to March 2019, there were 99 reported cases of deep vein thrombosis linked to Xeljanz and Xeljanz XR in the FDA database.


Xeljanz Pulmonary Embolism

Pulmonary embolism occurs when a blood clot gets wedged into a lung artery.


Xeljanz Death

One study of nearly 4,000 patients found there were nearly twice as many deaths (45 vs. 25) among patients taking high dose of tofacitinib versus patients taking TNF blockers.


Other side effects listed on the Xeljanz label include: respiratory infections, perforations of the stomach or intestines, lymphoma cancer, liver problems, non-melanoma skin cancer, and hypersensitivity reactions.


Who Manufactures Xeljanz?


Xeljanz is made by Pfizer Inc. It proved to be a blockbuster drug for Pfizer with aggressive marketing. The company spent more than $160 million to advertise Xeljanz in the first year, with sales jumping 170% from 2013-2014 to $308 million. By 2019, Xeljanz sold $423 million in the first quarter, up 34% year-over-year.


According to the Milwaukee Journal-Sentinel, Pfizer paid for a 2014 study of Xeljanz that was authored by 12 “experts” – all who had personal financial ties to the company. Not surprisingly, this panel found Xeljanz to be the “top treatment” for rheumatoid arthritis. Their studies compared Xeljanz to methotrexate alone, even though treatment experts typically prescribed methotrexate along with a low-dose steroid.


“Comparing the new treatment to a treatment that we already know is not good enough proves nothing,” said John Kirwan, emeritus professor of rheumatic disease at the UK’s University of Bristol. “You can’t help thinking that the company designed their study this way just to make their new treatment look good,” he told newspaper reporters.


Lawsuits against Pfizer charge the company with failures in design, manufacturing, and warnings.


What Do the FDA and European Medicines Agency Say About Xeljanz?


Xeljanz was first approved for marketing and distribution in the United States on November 6, 2012. Overseas, tofacitinib was not initially approved by the European Medicines Agency due to concerns over efficacy and safety. Animal studies showed some mutagenesis, fertility impairment, and carcinogenesis.


The European Commission finally approved Xeljanz in 2018, but only at the low dose for rheumatoid arthritis and not in new patients with ulcerative colitis. They are continuing to assess the rate of pulmonary embolism and mortality based on clinical data, deciding whether to alter their stance on the drug.


In February 2019, the U.S. Food and Drug Administration alerted the public to a clinical safety trial, which found an increased risk of blood clots in the lungs and death when patients take a 10 mg twice daily dose of Xeljanz for rheumatoid arthritis. The FDA has only approved this dose for the treatment of ulcerative colitis. They advise doctors to keep RA patients on a low 5 mg dose and monitor for signs of blood clot, such as sudden shortness of breath, excessive sweating, coughing up blood, bluish-colored skin, and chest pain.


In July 2019, the FDA approved a black box warning to indicate the increased risk of blood clots and death in people with rheumatoid arthritis who are over 50 years old and have at least one cardiovascular risk factor. People who use the drug for ulcerative colitis may also be at risk, as these studies are still ongoing.


Xeljanz Multidistrict Litigation, Class Actions, and Lawsuits


Arkansas resident Marilyn Stube filed a lawsuit against Pfizer, claiming that the drug she took for arthritis caused her to develop sepsis, resulting in the removal of all four of her limbs. After taking Xeljanz for four years, she developed a fever, nausea, and excessive pain. Doctors treated her for septic shock, multiple organ failure, gangrene, and Group A Streptococcus infection. The suit contends that elderly patients and those with a past history of infections like shingles are at increased risk of developing a serious infection while prescribed Xeljanz for an extended period. Pfizer knew of these risks and failed to warn the public, according to the claim.


Xeljanz lawsuits are being filed across the country. As of September 2019, there have been no Xeljanx lawsuit settlement amounts or jury awards.


The statute of limitations for personal injury lawsuits differs by state but ranges from one year in Louisiana to six years in Maine. In most states, plaintiffs have about two years to file a lawsuit. There may be extenuating circumstances in some cases if injured patients only recently discovered that Xeljanz could be the cause of their injuries. Contacting a qualified personal injury attorney is the best way to know for sure if you have a valid claim.


Contact a Xeljanz Lawyer


Since 1996, we’ve offered compassionate, yet aggressive, legal representation to patients harmed by the negligence of big pharmaceutical companies that put profits over people. Contact us for a free consultation today – you owe no fees unless we recover money on your behalf!