Xeljanz, Rinvoq, and Olumiant as Treatments for Inflammatory Disorders Have Been Under Scrutiny by FDA in the US
(Posted by Tom Lamb at Drug Injury Watch)
In December 2021 there was a notable JAK inhibitors drug class safety development in the US, with Xeljanz, Olumiant, and Rinvoq getting revised drug labels with more side effects warnings and more drug use restrictions. These December 2021 JAK inhibitors label changes were “new” but anticipated because back in September 2021 the FDA announced that it was requiring revisions to the “Black-Box” warnings already on the drug labels for Xeljanz, Olumiant, and Rinvoq “to include more information about the risks of serious heart-related events, cancer, blood clots, and death.”
Now the issue of JAK inhibitors drug class safety is coming up in Europe, as indicated by this European Medicines Agency (EMA) February 11, 2022, news item, "EMA starts safety review of Janus kinase inhibitors for inflammatory disorders".
Consistent with the December 2021 JAK inhibitors label changes mandated by the FDA here in the US, Xeljanz, Rinvoq, and Olumiant as treatments for inflammatory disorders are the subject of this JAK inhibitors safety review announced by the EMA in February 2022.
From the above-referenced EMA news item:
The review was prompted by the final results from a clinical trial (study A3921133) of the JAK inhibitor Xeljanz (tofacitinib). The results showed that patients taking Xeljanz for rheumatoid arthritis and who were at risk of heart disease were more likely to experience a major cardiovascular problem (such as heart attack, stroke or death due to cardiovascular disease) and had a higher risk of developing cancer than those treated with medicines belonging to the class of TNF-alpha inhibitors....
In addition, preliminary findings from an observational study involving another JAK inhibitor, Olumiant (baricitinib), also suggest an increased risk of major cardiovascular problems and VTE in patients with rheumatoid arthritis treated with Olumiant compared with those treated with TNF-alpha inhibitors.
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During this past 12 months, to the day, we have written these 12 earlier Drug Injury Watch articles which are relevant to Xeljanz, Rinvoq, and Olumiant, given that they are about JAK inhibitors drug class safety and JAK inhibitors label changes:
- Xeljanz FDA Drug Safety Communication in February 2021 Puts Heightened Scrutiny on Pfizer (February 11, 2021)
- Xeljanz Has A New Drug Safety Issue, We Just Don't Know How Significant It Is, Yet (February 17, 2021)
- Possible Ramifications of Recent FDA Alert About Xeljanz Heart Problems and Xeljanz-related Cancers (March 23, 2021)
- Xeljanz and Other JAK Inhibitors: Drug Safety Concerns Indicated by Recent FDA Actions (April 15, 2021)
- Possible FDA Advisory Committee Meeting for Xeljanz, Rinvoq, and Other Janus Kinase (JAK) Inhibitors (July 6, 2021)
- Xeljanz: FDA Warnings Updated: There are Higher Rates of Blood Clots and Deaths for Both Doses of Xeljanz, Now (September 1, 2021)
- Xeljanz: Drug-induced Peripheral Neuropathy as Possible Xeljanz Side Effect in 2 RA Patients (September 29, 2021)
- Xeljanz Risks of Cardiovascular Events, as well as Cancers, Cause More Xeljanz Use Limitations (October 12, 2021)
- Eli Lilly Attempts to Distance Olumiant From the Ominous JAK Inhibitors Drug Class Safety Issues Flagged by FDA (November 29, 2021)
- December 2021 JAK Inhibitors Drug Class Label Changes: More Warnings and Use Restrictions (December 9, 2021)
- Xeljanz Link to Cancers, Heart Attacks, Strokes, and Cardiovascular Deaths is Confirmed by Health Canada in January 2022 (January 14, 2022)
- Xeljanz Safety Study Final Data Details the Increased Risks of Cancers and Major Adverse Cardiovascular Events (January 31, 2022)
Our law firm is investigating possible drug injury lawsuits involving Xeljanz, Rinvoq, and Olumiant for patients who have suffered serious side effects or adverse drug reactions. Feel free to contact us if you or someone you know might have a Xeljanz, Rinvoq, or Olumiant drug injury case.
To learn more, you can visit the Xeljanz | Rinvoq | Olumiant Side Effects page on our Drug Injury Law website.
And, of course, we will continue to watch for future developments related to JAK inhibitors drug class safety and JAK inhibitors label changes, as we have done during the past 12 months.
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