Xeljanz Blood Clot Risk: FDA’s Final Warning

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Xeljanz: Increased Risk of Blood Clots and Death

Pfizer’s drug Xeljanz (tofacitinib), prescribed as a treatment for patients with Rheumatoid Arthritis, Psoriatic Arthritis and Ulcerative Colitis, now carries the FDA’s strictest and final warning before a drug is taken off the market: The Black Box Warning. Pfizer was first warned by the FDA about Xeljanz risks of serious injury back in February 2019 after a clinical trial revealed an increased risk of blood clots in patients taking 10 mg doses twice a day.

The FDA issued a new safety communication on July 26 informing patients and doctors about the new Black Box Warning as a major change to its labeling. This comes roughly five months after the FDA first warned about the drug’s risks. 

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“Increased risk of death in people 50 years of age and older with rheumatoid arthritis who have at least 1 heart disease (cardiovascular) risk factor”

Now, the FDA is warning patients taking the 10 mg dose for ulcerative colitis may also be at increased risk of blood clots and death. As a result, the agency limited the drug’s use in certain populations, and approved a boxed warning for the Xeljanz label. 

Black box warnings are the FDA’s strictest warnings for drugs and indicate that there is a serious risk of injury or death related to the drug. It is the final warning before a drug is taken off the market.  

Patients taking a higher dosage of Xeljanz have reported life-threatening blood clots that have led to:

  • Heart attack
  • Stroke
  • Arterial Thrombosis
  • Deep Vein Thrombosis
  • Pulmonary Embolism
  • Death

The FDA’s July 26 safety communication provides more information about the new boxed warning. The initial February safety communication can be found here

Xeljanz Blood Clot Lawsuits

Patients who took Xeljanz and developed blood clots in the lungs and other serious side effects are filing lawsuits against the maker of the drug, pharmaceutical giant Pfizer. 

Xeljanz side effects to look out for include:

  • Sudden shortness of breath
  • Difficulty breathing
  • Chest pain
  • Back pain
  • Coughing up blood
  • Excessive sweating
  • Clammy skin
  • Bluish colored skin

Arthritis and ulcerative colitis patients who have been experiencing any of these symptoms while taking the medication Xeljanz, you may want to contact your doctor or a medical professional immediately.

If you or someone you love was injured after taking Xeljanz, you may be entitled to financial compensation. Call the experienced Xeljanz attorneys at Schmidt National Law Group today at 1-800-631-5656 to see if you qualify for a Xeljanz Blood Clot Lawsuit