Xeljanz can cause pulmonary embolisms, according to one post-market study conducted by the manufacturer of Xeljanz, Pfizer. It was only in July of 2019 that the FDA required the drug’s warning label to be updated to disclose this risk.
As a result, numerous Xeljanz lawsuits have been filed against Pfizer for this particular side effect of the drug, claiming that Pfizer did not uphold its legal obligation to warn doctors and patients of the risks associated with taking Xeljanz.
The defective drug lawyers at the Shouse Law Office are representing victims who have taken Xeljanz and suffered a pulmonary embolism. In this article, they discuss:
- 1. What is Xeljanz?
- 2. Side effects of Xeljanz
- 3. What is a pulmonary embolism?
- 4. Post-marketing study finds Xeljanz increases the risk of a pulmonary embolism
- 5. Xeljanz lawsuits against Pfizer for pulmonary embolisms
1. What is Xeljanz?
Xeljanz is the brand name for the drug tofacitinib. This drug treats rheumatoid arthritis and ulcerative colitis by inhibiting Janus kinase enzymes. These enzymes dictate how cells transcribe DNA. If there are problems during this process, it can lead to joint inflammation and damage, causing arthritis.
Tofacitinib was created by Pfizer, the manufacturer of Xeljanz. It was first approved by the U.S. Food and Drug Administration (FDA) in November 2012, as a treatment for rheumatoid arthritis.1 Later on, in May 2018, the FDA extended the approved uses of Xeljanz to include treatment of ulcerative colitis.2
Since then, Xeljanz has become incredibly popular as a rheumatoid arthritis drug because it can be taken orally in pill form. Earlier rheumatoid arthritis medications had to be injected.
2. Side effects of Xeljanz
However, Xeljanz comes with numerous side effects, including:
- Sinus infections,
- Upper respiratory tract infections,
- Sore throat,
- Runny nose and nasal congestion, and
Xeljanz can also cause some far more severe side effects, including Liver damage,
- Cancer, and
- Pulmonary embolisms.
3. What is a pulmonary embolism?
A pulmonary embolism is an obstruction, often a blood clot, that travels to the lungs and blocks an artery.
Pulmonary embolisms can be fatal, with a controversial medical study finding that 26% of the people suffering from a pulmonary embolism who were given a placebo died from the condition.3 Another medical study estimated that around 50,000 people die of a pulmonary embolism in the U.S. every year.4
Even if they do not directly cause a fatality, pulmonary embolisms can cause serious medical complications that can also be fatal or extremely debilitating, including:
- Heart attack,
- Pulmonary infarction, or the death of lung tissue, and
- Recurring pulmonary embolism.
3.1 Symptoms of a pulmonary embolism
The symptoms of a pulmonary embolism can vary widely, depending on the extent of the blockage and how much of the lungs are compromised. However, most people suffering from one experience:
- A sudden shortness of breath,
- Intense chest pain, especially when you take a deep breath,
- Coughing, which can produce blood,
- Leg swelling, often in the calf,
- Heart arrhythmia,
- Fainting, or
- Lightheadedness or dizziness.
4. Post-marketing study finds Xeljanz increases the risk of a pulmonary embolism
A post-marketing study found that Xeljanz drastically increased the likelihood of someone suffering a pulmonary embolism.
Post-marketing studies are often required by the FDA when they have suspicions or concerns that a specific drug is going to have certain adverse effects on the people who take it. The FDA can require that pharmaceutical companies conduct post-marketing trials as a condition of the FDA’s approval of their drug. This allows the drug to enter the market and benefit patients and make a profit for the drug company, while still obtaining important safety information for the FDA.
In the case of Xeljanz, the FDA approved the drug for use as a treatment for rheumatoid arthritis on the condition that its manufacturer, Pfizer, conduct a post-marketing study. This study was to compare how well Xeljanz performed against a tumor necrosis factor inhibitor drug. In particular, the FDA wanted to know if Xeljanz had cardiovascular risks for people over 50 who already had a history or propensity for heart conditions like heart disease or a heart attack.5
The resulting post-marketing study was Study A3921133.6 It began on March 14, 2014, is scheduled to end on March 3, 2020, and covers 4,400 participants.
Preliminary results from Study A3921133 were so disturbing that Pfizer had to step in to prevent further damage. People who were taking 10 milligram doses of Xeljanz twice every day were having pulmonary embolisms five times as often as study participants in the control arm of the study who were taking a tumor necrosis factor inhibitor drug.7 Patients taking 10 milligrams of Xeljanz twice every day were also having pulmonary embolisms three times as often as the group taking 5 milligrams of Xeljanz twice a day.
As of July 2019, the FDA ordered Pfizer to put a black box warning on the drug.8
5. Xeljanz lawsuits against Pfizer for pulmonary embolisms
Hundreds of people have filed mass tort lawsuits against Pfizer for the losses they have suffered after taking Xeljanz and suffering a pulmonary embolism. These lawsuits claim that Pfizer failed to warn doctors and patients of the risks of taking their drugs.
Pharmaceutical companies like Pfizer have a legal duty to tell doctors about the dangers and the side effects related to the drugs they manufacture. Doctors rely on these disclosures to prescribe drugs to their patients to treat their medical conditions. Patients also rely on these disclosures to make an informed decision about their health. However, pharmaceutical companies understand that disclosing all of the risks and side effects related to their products can undercut their profits by deterring doctors and patients.
The law, however, requires drug companies to make reasonable discloses. The lawsuits against Pfizer claim that the company failed to uphold this legal duty when it comes to the risks of Xeljanz causing a pulmonary embolism.
These lawsuits seek compensation for a victim’s losses, including:
- Medical expenses,
- Pain and suffering,
- Professional setbacks, including lost wages and reduced earning capacity, and
- Loss of consortium for the victim’s family.
Many Xeljanz claims also seek punitive damages to hold Pfizer accountable for its conduct.
While all of these Xeljanz lawsuits are currently moving through the legal system on their own, it seems likely that they will be consolidated into multidistrict litigation, or MDL, in the near future because they involve hundreds of similar victims suing a defendant for a single course of conduct.
- FDA Approval Letter for Xeljanz (November 6, 2012).
- FDA Approval Letter for Xeljanz to Treat Ulcerative Colitis (May 30, 2018).
- Barritt DW, Jordan SC, “Anticoagulant Drugs in the Treatment of Pulmonary Embolism,” The Lancet 275(7138):1309-12 (June 18, 1960).
- See Rahimtoola A, Bergin JD, “Acute pulmonary embolism: an update on diagnosis and management,” Current Problems in Radiology 30(2):61-114 (February 2005).
- See Press Release, “Increased risk of pulmonary embolism and mortality in rheumatoidarthritis patients receiving 10mg twice daily in a clinical trial,” Pfizer (March 26, 2019).
- ClinicalTrials.gov Identifier No. NCT02092467, “Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis.”
- See note 5.
- See note 5; Allison Prang, “FDA Requires Box Warnings for Pfizer Drug Xeljanz Patients taking 10-milligram dose twice a day could experience a higher risk of blood clots or death,” Wall Street Journal (July 26, 2019).