UPDATE: (June 26, 2019) – The U.S. Food & Drug administration has issued new “Black-Boxed” warnings about the increased risk of blood clots and death associated with the 10mg dose of Xeljanz and Xeljanz XR, advising that a 10mg twice daily dosage is not approved or recommended for treatment of rheumatoid or psoriatic arthritis and is only for initial treatment for ulcerative colitis and for long-term use in limited situations.
In addition, an Arkansas woman recently sued Phizer alleging the company failed to warn her and other Xeljanz users in the United States that the drug could cause one to develop sepsis, which sadly resulted in her having to undergo quadruple amputation. Although the label for Xeljanz in Europe, Canada and other countries does warn against the risk of sepsis, the U.S. label/packaging Xeljanz does not. Notably, an arthritis drug Pfizer previously sold (Enbrel) did have a warning regarding the risk of developing sepsis on the U.S. and other countries labels/packaging.
Xeljanz is a drug made by Pfizer to treat moderate to severe rheumatoid arthritis inflammation. The drug, first approved in 2012, works by blocking certain enzymes and suppressing a user’s immune system. An “extended release” form of the drug, Xeljanz XR was approved for treatment of active psoriatic arthritis in 2017. Pfizer made about $1.7 billion off Xeljanz and Xeljanz XR in 2018 alone.
Last February the U.S. Food & Drug Administration issued a warning about an increased risk of developing a Pulmonary Embolism in Xeljanz users – preliminary results from ongoing clinical studies indicated individuals taking 10mg of Xeljanz twice a day were 3 to 5 times more likely to develop a blood clot in the lungs compared to individuals using alternative arthritis medications. Between 2013 and 2018, the FDA received over 40,000 adverse event reports concerning Xeljanz and Xeljanz XR, almost 1,000 of which were deaths.
A pulmonary embolism is a life-threatening condition that occurs when a blood clot occurs in an artery in the lungs. The condition constitutes a medical emergency that requires immediate treatment. Blood clots can form in or travel to the blood vessels in the brain, heart, kidneys, lungs, arms and legs. This can lead to a heart attack, stroke, damage to the body’s organs, or death. Even Pfizer has admitted that Xeljanz users have a significantly higher risk of developing blood clots than other comparable drugs.
We are investigating cases where individuals prescribed 10mg doses of Xeljanz or Xeljanz XR twice a day for rheumatoid or psoriatic arthritis suffered a stroke, Pulmonary Embolism or died, or took the drug and developed sepsis. Contact us online or call us at 1-866-252-3535 for a free consultation.
Do not stop taking any medication without consulting your healthcare provider.