Pfizer’s Xeljanz (tofacitinib) is a drug used to treat patients with arthritis and ulcerative colitis. Xeljanz helps to regulate immune system activity, which can provide relief to people suffering from chronic inflammatory conditions. The drug has been on the market since 2012 and continues to gain FDA approval for new uses.
But as the number of Xeljanz indications grows, so does knowledge about the drug’s dangerous side effects. Over the last couple of years, FDA safety alerts have warned that Xeljanz may increase the risk of blood clots, heart problems, cancer, and even death. These warnings may be too little, too late for the many patients who took Xeljanz without knowing about these risks. Some patients are now filing lawsuits against Pfizer, claiming that the company designed a defective drug and failed to adequately warn about the risks of serious, potentially-deadly side effects.
You may be eligible for a lawsuit if you took Xeljanz and were diagnosed with a malignancy, heart-related issue, or thrombosis. Our nationally-recognized dangerous-drug attorneys are reviewing these cases for free and accepting them on a contingency-fee basis. Schedule a complimentary case review using our online contact form.
What is Xeljanz Prescribed For?
Xeljanz has been prescribed for nearly 10 years since initial approval in 2012 for adults with rheumatoid arthritis. Xeljanz was approved to treat adults with psoriatic arthritis in 2017 and adults with ulcerative colitis in 2018. In 2020, Xeljanz was approved to treat children ages 2 and older with polyarticular juvenile idiopathic arthritis. According to the drug’s official website, Xeljanz is the first and only JAK inhibitor approved for three adult conditions.
How Does Xeljanz Work?
Tofacitinib, the main active ingredient of Xeljanz, works by decreasing immune system activity. An overactive immune system contributes to rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.
Xeljanz is a Janus kinase (JAK) inhibitor that decreases the amount of cytokines the body produces. Cytokines are signaling proteins involved in regulating immune system responses. The body occasionally increases its production of cytokines in response to infections. Inflammation is the body’s protective response against infection. But in people with chronic inflammatory conditions, such as rheumatoid arthritis and ulcerative colitis, the body may release excess cytokines.
Xeljanz inhibits, or blocks, the release of cytokines in the JAK signal pathway, reducing chronic inflammation and its symptoms. It’s typically prescribed to chronic inflammatory patients who have not experienced relief from other drugs that are normally given as a first line of defense.
How Much Does Pfizer Spend on Xeljanz Advertising?
Xeljanz has many competitors, particularly for the treatment of rheumatoid arthritis. The global market for RA drugs is expected to reach nearly $63 billion by 2027, up from an estimated $58 billion in 2019.
This strong competition for market share drives advertising spending. Pfizer spends over $100 million per year to advertise Xeljanz, including in digital, print, and national TV ads. In December 2020 alone, Pfizer spent $27.6 on Xeljanz TV ads, reports Fierce Pharma. That was just one month before the release of new safety data showing that Xeljanz may increase the risk of serious heart-related problems and cancer.
What Are the Most Common Xeljanz Side Effects?
Possible side effects of Xeljanz include:
- Upper respiratory tract infection (such as the common cold)
- High blood pressure
- Elevated cholesterol levels
- Serious infections
- Blood clots
- Cancer and immune system problems
- Cardiovascular problems
- Tears in the stomach or intestines
Why Did the FDA Issue Xeljanz Safety Warnings?
Drug safety testing doesn’t always end with premarketing clinical testing. Sometimes, after it approves a drug, the FDA orders “post-marketing” safety studies, or ongoing studies. Based on the results of this testing, the FDA may issue stronger product warnings to reflect the latest safety data.
When it first approved Xeljanz in 2012, the FDA required post-marketing studies to evaluate the risk of heart-related events, cancer, and infections. Specifically, the FDA wanted to compare the safety of Xeljanz to a TNF inhibitor (another type of anti-inflammatory drug). In February 2019, the FDA issued a Drug Safety Communication about Xeljanz because the postmarketing study found an increased risk of blood clots in the lungs and death. The FDA further investigated this issue and later approved a new boxed warning about these side effects.
Also in February 2021, new data from the post-marketing study prompted another FDA warning, this time about an increased risk of serious heart-related problems and cancer from Xeljanz. While the FDA has not yet issued a new boxed warning for these side effects, they are highly concerning to Xeljanz patients.
What Are the Risks of Xeljanz and Blood Clots?
Thrombosis—including pulmonary embolism (a blood clot that travels to the lungs), deep venous thrombosis (a blood clot in a deep vein, usually the legs), and arterial thrombosis (a blood clot in an artery)—have occurred in patients treated with Xeljanz.
The FDA notes that an analysis of the Xeljanz post-marketing study found an increased occurrence of blood clots in the lungs. The finding was for the 10 mg twice daily dose of Xeljanz. Many of the blood clots were serious and some resulted in death. Blood clots can also cause heart attack, stroke, and damage to the body’s organs.
What Are the Risks of Xeljanz and Cancer?
Lymphoma, melanoma, lung cancer, breast cancer, prostate cancer, pancreatic cancer, and other cancers have been observed in Xeljanz patients. Out of 4,362 test subjects in the post-marketing study, 164 developed malignancies. The FDA alerted the public to Xeljanz cancer risks in February, 2021.
What Are the Risks of Xeljanz and Cardiovascular Problems?
In February 2021, the FDA warned about serious heart related problems linked to Xeljanz. In a press release about the post-marketing study results, Pfizer calls these “major adverse cardiovascular events” (MACE). In the study, a total of 135 patients had MACE. Slightly more cardiovascular events occurred with the 10 mg dose than with the 5 mg dose. The most frequently reported event was a heart attack.
Other types of cardiovascular problems that could occur from Xeljanz include cardiac arrest, cardiovascular death, ischemic stroke, acute coronary syndrome, heart failure, and atrial fibrillation.
Am I Eligible for a Xeljanz Lawsuit?
Like other Xeljanz patients, you are probably wondering why Pfizer was ordered to study the drug’s deadly side effects after it was approved and available to the public. If the company was aware of such problems, shouldn’t it have provided warnings from the time it went on the market?
Our attorneys understand your concerns and are here to help. We have a long history of taking on the pharmaceutical industry and winning compensation for our clients. You may be eligible for a Xeljanz lawsuit if you took the drug and were diagnosed with cancer, a heart problem, or a blood clot.
A free consultation is the first step in the legal process. Use our contact form to provide your contact details and a brief case description, and a Xeljanz lawyer will get back to you soon. You can also call us now at 855 696 0024.