Xeljanz Side Effects Linked To Pulmonary Embolism, DVT, Blood Clots and Wrongful Death

By Harvey Kirk
Posted July 26, 2019

ADD YOUR COMMENTS

Studies have found a link between Xeljanz and blood clots, including an increased risk of a serious and potentially life-threatening pulmonary embolism. As a result of the blood clot risk, the FDA now requires Pfizer to include a “black box” warning about this side effect of Xeljanz (tofacitinib) when higher doses are prescribed, advising doctors to be aware of reports involving pulmonary embolism, deep vein thrombosis (DVT), arterial thrombosis and death.

While this new information helps make patients aware of both the pulmonary embolism risk and the importance of seeking immediate medical attention if blood clot problems develop, many serious and devastating injuries may have been avoided if earlier warnings had been provided.

What Types of Blood Clots Are Caused by Xeljanz?

The product liability lawyers at Saiontz & Kirk, P.A. previously investigated Xeljanz blood clot lawsuits against Pfizer for individuals who suffered any of the following types of blood clots caused by Xeljanz side effects:

• Pulmonary Embolism
• Deep Vein Thrombosis
• Arterial Thrombosis
• Ischemic Stroke
• Hospitalization due to a Blood Clot Injury
• Wrongful Death

Xeljanz Blood Clot & Pulmonary Embolism Warnings Added to Label

In a safety alert, the FDA indicated that the strongest label warning possible will be added to Xeljanz and Xeljanz XR, containing information about blood clot risks.

Xeljanz is approved for the treatment of rheumatoid arthritis, psoriatic arthritis, and moderate to severe ulcerative colitis, often involves a twice daily 10mg dose that has been shown to increase the risk of blood clot in the lungs, known as a pulmonary embolism. Certain users may also face a risk of blood clots in the leg, thigh or pelvis, known as a deep vein thrombosis (DVT).

Should you stop taking Xeljanz?

Individuals taking Xeljanz should never stop taking the drug without first talking to their doctor. However, the new warnings now provide critical information that users should stop taking Xeljanz and seek immediate medical attention if they experience any signs of a blood clot or pulmonary embolism including:

• Shortness of breath
• Chest pain or back pain
• Coughing up blood
• Sweating
• Swelling of a leg or arm
• Bluish or clammy skin
• Leg pain or tenderness, or red/discolored skin

Blood Clot Side Effects of Xeljanz Particularly Linked to Higher Doses

When the FDA first approved Xeljanz in 2012, Pfizer was required to conduct a post-marketing clinical trial to evaluate the heart risks, cancer risks and infection risks. The trial involved evaluation of the 5mg twice daily dose, which is currently approved for rheumatoid arthritis, and a higher 10mg twice daily dose that is often used for ulcerative colitis and may be prescribed by some doctors.

Lawsuits alleged that Pfizer knew or should have known about the Xeljanz blood clot risk highlighted in this study much earlier. Yet, they failed to adequately research the potential Xeljanz side effects before the drug was ever introduced or approved.

If earlier warnings had been provided to users and the medical community about the importance of monitoring for signs or symptoms of a blood clot, many individuals may have avoided a pulmonary embolism, deep vein thrombosis, stroke or wrongful death.

In addition to blood clot risks, the FDA has issued an updated warning in February 2021 about the potential link between Xeljanz and cancer, heart attacks and other cardiovascular risks.