FDA Cracks Down on JAK Inhibitor Drug Class for Increased Risk of Serious Heart-Related Events, Cancer, and Death
Written by: Lauren Schwab, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
As mentioned previously in our blog post "December 2021 JAK Inhibitors Drug Class Label Changes: More Warning and Use Restrictions", the Food and Drug Administration (FDA) has been keeping a close eye on Xeljanz, Rinvoq, and Olumiant for adverse events, and has already implemented several label changes.
As background, here are links to the "new" drug label for Xeljanz, Olumiant, and Rinvoq:
- Current Prescribing Information for Xeljanz (Revised: 12/2021)
- Current Prescribing Information for Olumiant (Revised: 12/2021)
- Current Prescribing Information for Rinvoq (Revised: 12/2021)
A December 2021 article, "FDA adds strict safety warnings on arthritis drugs from Pfizer, AbbVie and Lilly", addresses the FDA's decision to add a new black box warning to Xeljanz and other drugs within the JAK inhibitors class.
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Since the addition of the revised "Black-Box" warning to the respective drug labels, Pfizer's Xeljanz, AbbVie's Rinvoq, and Lilly's Olumiant are now being recommended for use only in patients who did not have a positive treatment response when using one of the medicines that are part of the TNF blockers drug class.
According to this December 2021 article, "FDA adds strict safety warnings on arthritis drugs from Pfizer, AbbVie and Lilly", the revised "Black-Box" warnings on Xeljanx, Rinvoq, and Olumiant address the increased risks of serious side effects associated with these JAK inhibitors:
The Food and Drug Administration's boxed warnings on the labels of Rinvoq , Xeljanz and Lilly's Olumiant flags the risk of cardiovascular death and stroke in high-risk patients who are aged 50 and above, and are current or past smokers.
Additional information about the risk of some types of cancer and death was also added to their labels.
At the present time, our law firm is investigating Xeljanz, Rinvoq, and Olumiant lawsuits for patients using a JAK inhibitor then developing heart problems such as heart attacks, strokes, pulmonary embolism (PE), and deep vein thrombosis (DVT), as well as lymphoma, lung cancer, and other cancers. Please feel free to contact us if we can help you or someone you know with a Xeljanz, Rinvoq, or Olumiant drug injury case.
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