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Pfizer’s FDA-Mandated Xeljanz Safety Clinical Trial

In January 2021, Pfizer, the manufacturer of the rheumatoid arthritis drug Xeljanz®, announced the results of the safety clinical trial mandated by the U.S. Food and Drug Administration (FDA). The study analyzed the safety of tofacitinib, the active ingredient in Xeljanz, at two doses: 5 mg twice daily and 10 mg twice daily.

Patients taking Xeljanz at both doses were compared to patients taking another medication (TNF inhibitors) to treat their rheumatoid arthritis. The patients were all over 50 years old and had at least one additional cardiovascular health condition or factor. In total, there were 4,362 subjects and 135 subjects had major adverse cardiovascular events (MACE) and 164 had malignancies (the presence of cancerous cells). Pfizer revealed the most common MACE was heart attacks and the most common malignancy was lung cancer.

Both Xeljanz doses were determined to carry a larger risk of death, malignancies, and thrombosis (blood clotting in blood vessels) compared to the TNF inhibitor.

There was a dose-dependent increased risk of MACE, all-cause mortality, and thrombosis at both the 5 mg and 10 mg twice daily doses of Xeljanz compared to the TNF inhibitors. There was also a non-dose-dependent increased risk of malignancy excluding non-malignant skin cancer at both Xeljanz doses compared to TNF inhibitors. Lymphoma and other malignancies were also observed in the Xeljanz patients and were most likely to occur with the 10 mg twice daily dose.

Other malignancies observed in the studies included:

  • Lung cancer
  • Breast cancer
  • Melanoma
  • Prostate cancer
  • Pancreatic cancer
  • Non-metastatic skin cancer

Current and former smokers had an overall higher risk of cancer after taking Xeljanz. Thrombosis, including pulmonary embolisms, deep venous thrombosis, and arterial thrombosis also occurred in the Xeljanz patients.

FDA Response to the Trial Results

In September 2021, the FDA responded to the safety clinical trial results with regulations and recommendations. The FDA reviewed the results and concluded that there is an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with Xeljanz use.

Specifically, the FDA concluded there is a higher rate of blood clots and death seen in both the 5 mg twice daily and the 10 mg twice daily doses of Xeljanz compared to the alternative TNF blocker medication. There is a higher rate of lymphomas observed in Xeljanz patients in addition to a higher rate of lung cancer in Xeljanz patients who are current or past smokers.

Due to the results, the FDA is now requiring updated Black Box warnings about the risk of serious heart-related events, cancer, blood clots, and death for Xeljanz and two other arthritis medicines in the same class: Olumiant and Rinvoq.

The FDA also updated their recommendations for Xeljanz, Olumiant, and Rinvoq in light of the study’s results. The medications are only to be used by patients who are not treated effectively or experience serious side effects with TNF blockers. The FDA recommends patients taking these medications notify their healthcare providers immediately, especially if they are a current or past smoker, had a heart attack, or have another heart problem like strokes or blood clots.

Heart Attack Symptoms

If you are experiencing potential heart attack, stroke, or blood clot symptoms, dial 911.

If you take Xeljanz, Olumiant, or Rinvoq, then you should be closely aware of heart attack symptoms. Pay attention to your own health and take immediate action to get emergency medical care if you start showing symptoms.

Common symptoms of a heart attack include:

  • Centralized chest discomfort that lasts for minutes, or that worsens and recedes in cycles.
  • Sharp chest, throat, neck, or jaw pressure, pain, tightness, or heaviness.
  • Arm, back, neck, jaw, or stomach pain or discomfort.
  • Sudden shortness of breath, not necessarily accompanied by chest discomfort.
  • Sudden breakout of cold sweat.
  • Nausea, vomiting, or lightheadedness spell.
  • Unexplained weakness on one side of the body or affecting one body part.
  • Slurred speech, especially when it occurs suddenly.
  • Droopiness to one side of the mouth.
  • Leg or arm swelling, tenderness, or red discoloration.

How GoldenbergLaw Can Help

If you or a loved one experienced heart problems, a stroke, or blood clots after taking Xeljanz, contact our Minnesota Xeljanz attorneys of GoldenbergLaw. Our team has more than 35 years of experience holding manufacturers accountable for dangerous drugs and getting justice for our clients. Contact us today!

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