Xeljanz and Xeljanz XR
Xeljanz and Xeljanz XR are Janus Kinase Inhibitors (JAKs)
that treat rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.
Xeljanz and Xeljanz XR work by suppressing the immune
system, this puts the body at risk for ailments and adverse side effects. One
side effect that Pfizer, the manufacturer of Xeljanz, fails to warn consumers
about is the increased risk for blood clots, which can ultimately prove fatal.
Common Problems Experienced with Xeljanz and Xeljanz XR
If you or a loved one have experienced the following
symptoms, contact VanDerGinst Law right away as you may qualify for
- Pulmonary embolism
- Pulmonary thrombosis
- Deep vein thrombosis
- Blood clot
FDA Black Box Warning
Xeljanz was first approved by the Food and Drug Administration
(FDA) in 2012. As of 2018, both Xeljanz and Xeljanz XR have garnered around
1.74 billion in sales.
A black box warning is the most severe warning that can be
put on a drug. On July 30, 2019, the FDA added a black box warning to Xeljanz
and Xeljanz XR (Tofacitinib). It warned that taking Xeljanz 10 mg twice daily
vs. 5 mg twice daily could increase the risk of death from any cause as well as
thrombosis in rheumatoid arthritis patients with at least one cardiovascular
risk factor. Thrombosis is when a blood clot forms in a blood vessel, which can
also be a fatal event. While patients taking the 10 mg twice daily dose do have
a higher risk of death and thrombosis, those on lower doses (for example, 5 mg
twice daily) are still at risk of suffering from these events as well.
Are Label Changes Enough?
Big label changes regarding dosage information were added to
the Xeljanz label following this black box warning. These included that Xeljanz
should only be used at the lowest effective dose and for the shortest duration
needed to achieve therapeutic response for ulcerative colitis. Additionally, it
added that patients with an increased risk of thrombosis should avoid the use
of Xeljanz. Lastly, it added that “the recommended dose for Xeljanz XR is 11 mg
once daily. A dosage of Xeljanz 10 mg twice daily or Xeljanz XR 22 mg once
daily is not a recommended regimen for the treatment of rheumatoid arthritis.”
Label changes are a common practice used by big pharmaceutical companies to
downplay the risks of a medication.
Have You Been Affected by Xeljanz or Xeljanz XR?
If you or loved one was being
treated for arthritis with Xeljanz or Xeljanz XR and has experienced pulmonary
embolism, pulmonary thrombosis, deep vein thrombosis, stroke, other blood
clots, or death due to the drug, you may be entitled to compensation. At
VanDerGinst Law, we have a team of experienced, knowledgeable attorneys ready
to help you every step of the way. If we don’t win, you don’t pay. Guaranteed.
Instead of trying to deal with big insurance companies, focus on getting better
and leave the rest to us. VanDerGinst Law has represented thousands of injury
victims and has recovered hundreds of millions of dollars on their behalf—we’ll
fight to get you the compensation you deserve. Contact VanDerGinst Law to set
up a free consultation to review your case.