Xeljanz Complications: Drug commonly used to treat Rheumatoid Arthritis leads to blood clots and pulmonary embolism

Product Liability attorneys are investigating claims by Rheumatoid Arthritis (RA) patients who have developed severe Xeljanz complications like paraplegia or limb paralysis after taking the drug.

There are also reports of Xeljanz complications linked to blood clots, deep vein thrombosis and pulmonary embolism. The U.S. Food and Drug Administration (FDA) has received multiple adverse event reports for patients taking Xeljanz or Xeljanz XR, and in 2017 warned the public of certain risks.

At that time the FDA approved labeling changes for Xeljanz that printed warnings for new risks of appendicitis, interstitial lung disease, pancreatic cancer, and disseminated varicella zoster vaccine virus infection. Risks for lung cancer, breast cancer, melanoma, and prostate cancer were also added to the black box warning.

The FDA first approved Xeljanz in 2012 to treat moderate to severe active rheumatoid arthritis, one of the most common and disabling types of autoimmune arthritis, affecting more than 1.3 million people in the U.S. RA results in pain and swelling in the joints of the hands and feet, and can also affect the eyes, skin, or lungs.

Joe Lyon is a highly-rated Ohio product liability lawyer representing plaintiffs nationwide in a wide variety of civil litigation claims against pharmaceutical companies

Xeljanz Injury

The US Food and Drug Administration (FDA) has newly added a warning to tofacitinib (Xeljanz and Xeljanz XR) stating an increased risk for pulmonary embolism, and possible and death. The FDA warns that patients taking a 10-mg twice-daily dose of Xeljanz, recommended for patients with ulcerative colitis, could present an added blood clot risk.

Also, the FDA has limited the use of Xeljanz for ulcerative colitis to only patients who are treated inadequately or experience severe adverse effects with alternative drugs. The Xeljanz risk warnings follow a review of data from a post-marketing safety study of tofacitinib (Xeljanz) in patients with rheumatoid arthritis. Higher doses of the drug presented an added risk of pulmonary embolism.

The safety study found an increased occurrence of blood clots when patients are treated with 10 mg twice daily compared with patients treated with 5 mg twice daily. The 10-mg dose of tofacitinib is not approved for rheumatoid arthritis or psoriatic arthritis, only approved for ulcerative colitis.

The FDA stated in the recent warning: “While the increased risks of blood clots and of death were seen in patients taking this dose for RA, these risks may also apply to those taking tofacitinib for ulcerative colitis.” The FDA first warned about the Xeljanz risk in February 2019.

Xeljanz Complications & Blood Clots

Pfizer and the FDA have warned adult patients with moderate to severe rheumatoid arthritis as well as doctors of the irregularities in dosage risks. The report underscores the longstanding issue with marketing and selling drugs to the public before such trials can be studied for short and long-term health risks like pulmonary embolism, deep vein thrombosis and other serious complications.

Xeljanz works by decreasing the activity of a patient’s immune system. It was first approved to treat adult RA patients who did not respond well to methotrexate. In 2017, the FDA approved the medicine to treat patients with psoriatic arthritis who did not respond well to non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

In 2018, the FDA approved tofacitinib to treat ulcerative colitis, a chronic, inflammatory bowel disease. During the most recent safety trial, researchers found an increased occurrence of blood clots in the lungs when patients are treated with tofacitinib 10 mg twice daily. The study results identified 19 cases of Pulmonary Embolism and 45 deaths.

Health care professionals and clinical trial researchers are still in the process of studying the drug safety risks of Xeljianz and other rheumatoid arthritis medications.

Serious Xeljanz side effects or complications that may be associated with the drug include:

  • Blood Clots
  • Deep vein thrombosis (DVT)
  • Pulmonary embolism
  • Paraplegia
  • Limb paralysis
  • Perforations the stomach or intestines
  • Lymphoma
  • Liver damage
  • Non-melanoma skin cancers

Xeljanz Pulmonary Embolism

Pulmonary embolism occurs when material, most often a blood clot, gets wedged into an artery in the lungs, commonly coming from the deep veins of your legs, a condition known as deep vein thrombosis.

About one-third of people with undiagnosed and untreated pulmonary embolism die. When the condition is diagnosed and treated promptly, the prognosis is much improved.

There are complications that may include the development of pulmonary hypertension, a condition where the blood pressure in the lungs and in the right side of the heart is too high.

Pulmonary embolism symptoms can vary and depend mostly on how much of the lung is compromised, the size of the blood clots, and the presence of underlying lung or heart disease. Pulmonary embolism can be life-threatening. Common signs and symptoms may include:

  • Shortness of breath—worse with physical exertion
  • Severe chest pain
  • Cough—possible blood-streaked sputum
  • Leg pain or swelling
  • Clammy skin or skin discoloration
  • Fever
  • Excessive sweating
  • Rapid or irregular heartbeat (arrhythmia)
  • Lightheadedness or dizziness

Ohio Xeljanz Attorney

Following any drug injury incident, whether it is a blood clot or pulmonary embolism, kidney or liver damage, plaintiffs may choose to seek compensation. Defective drugs may be the cause of an illness and injury, and drug manufacturers may be held liable for damages.

The Lyon Firm has experience engaging large drug companies in complex drug injury litigation. Large settlements are likely for injured plaintiffs if there is evidence that the company failed to properly test their product or failed to warn consumers of the potential health risks and complications.

What is Rheumatoid Arthritis?

Rheumatoid arthritis (RA) is the most common and disabling types of autoimmune arthritis. It affects more than 1.3 million people in the U.S., most of them (75 percent) women. RA is caused by an ineffective immune system and results in pain and swelling of the wrist and small joints of the hands and feet.

Rheumatoid arthritis is a chronic inflammatory disorder that can affect more than just your joints. In some people, the condition also can damage a wide variety of body systems, including the skin, eyes, lungs, heart and blood vessels.

Rheumatoid arthritis affects the lining of your joints, causing a painful swelling that can eventually result in bone erosion and joint deformity. Common signs of RA include loss of energy, low-grade fevers, reduced appetite, a dry mouth associated with Sjogren’s syndrome, and rheumatoid nodules that form beneath the skin.

RA presents typically with tender, warm, swollen, stiff joints, usually worse in the mornings and after inactivity. As the disease progresses, symptoms can spread to the wrists, knees, ankles, elbows, hips and shoulders. In most cases, symptoms occur in the same joints on both sides of your body. Rheumatoid arthritis symptoms may vary in severity and come and go with increased disease activity, called flares.

Rheumatoid arthritis occurs when an immune system attacks the synovium, the lining of the membranes surrounding joints. The inflammation thickens the synovium, which can eventually destroy the cartilage and bone. Tendons and ligaments that hold a joint together weaken and stretch, and the joint loses its shape and alignment.

Risk factors for rheumatoid arthritis include gender (women are more likely to have RA), age, family history, obesity, smoking, and environmental exposures. Exposures to asbestos or silica may increase the risk for developing rheumatoid arthritis.

If you or a loved one has suffered a blood clot or pulmonary embolism due to Xeljanz use, and have questions about the legal remedies available to improve quality of life and medical care in Ohio, contact The Lyon Firm at (800) 513-2403.

You will speak directly with Mr. Lyon, and he will help you answer critical questions regarding Xeljanz complications, blood clots and pulmonary embolism.