September 10, 2021 — San Diego, CA. The US FDA has issued a new drug safety warning for Janus Kinase (JAK) inhibitors.
Xeljanz heart-related problems and blood clot risks are prompting lawsuits in all 50 states and in Canada, this is an ongoing class action lawsuit.
This is the fourth time that the FDA has issued concerns over this drug used to treat arthritis and ulcerative colitis, the first drug safety warning was on February, 2019. This drug has an FDA Black-Box Warning – the highest level warning from the FDA.
What is the new Xeljanz warning about?
According to the FDA’s MedWatch website the FDA is requiring revisions to the Boxed Warning Label (the FDA’s most serious warning) for Xeljanz/Xeljanz XR (tofacitinib), Olumiant (baricitinib) and Rinvoq (upadacitinib) to include information about the risks of serious heart-related events, cancer, blood clots, and death.
This new warning is based on a large clinical trial and the FDA found the following:
“There is an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with the arthritis and ulcerative colitis medicines Xeljanz and Xeljanz XR. This trial compared Xeljanz with another type of medicine used to treat arthritis called tumor necrosis factor (TNF) blockers in patients with rheumatoid arthritis. The trial’s final results also showed an increased risk of blood clots and death with the lower dose of Xeljanz.”
FDA’s new recommendation for smokers taking Xeljanz/Xeljanz XR.
Directly from the FDA: “Patients who aretaking Xeljanz/Xeljanz XR, Olumiant, or Rinvoq should tell their health care professional if they are a current or past smoker, or have had a heart attack, other heart problems, stroke, or blood clots in the past as these may put them at higher risk for serious problems with the medicines. Patients starting these medicines should also tell their health care professional about these risk factors. Patients should seek emergency help right away if they have any symptoms that may signal a heart attack, stroke, or blood clot. Treatment with these medicines is associated with an increased risk of certain cancers including lymphoma and lung cancer. Patients should also talk to their health care professional if they have any questions or concerns.”
History of problems with Xeljanz.
Xeljanz was approved by the U.S. Food and Drug Administration (FDA) in 2012 to treat people with rheumatoid arthritis (RA), who didn’t respond well to traditional RA treatments. The first drug of its kind on the market, Xeljanz was touted as an easy-to-take treatment for patients suffering from the painful effects of RA.
Since its release to the market, Xeljanz has been associated with serious adverse effects, including the risk of deadly infections and even cancer. Now, the FDA is warning about an increased risk of blood clots in the lungs and death when taking a high dose of Xeljanz. Patients taking the drug should be aware of these risks and talk with their doctors if they believe they are at increased risk for side effects.
The most common side effects of Xeljanz include:
Other potential serious side effects of RA and PA patients include:
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.
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.
New FDA Alert for Xeljanz/Xeljanz XR – Cancer, Blood Clots, Death Page updated on September 10, 2021