Do the JAK Inhibitors Rinvoq and Olumiant Also Have an Increased Risk of These Adverse Drug Events and Side Effects?
(Posted by Tom Lamb at Drug Injury Watch)
In February 2021 this FDA Drug Safety Communication, "Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)"' was released. Since then, that FDA alert about Xeljanz-associated heart problems and possible Xeljanz-related cancers has raised concerns about whether all Janus kinase (JAK) inhibitors share these adverse drug events and side effects risks.
Specifically, besides Xeljanz there are two other JAK inhibitors approved by the FDA:
- Olumiant (baricitinib) from Eli Lilly & Co.; and,
- Rinvoq (upadacitinib) from AbbVie.
As such, besides just watching for new information about Xeljanz-associated heart problems and possible Xeljanz-related cancers, are looking for any developments concerning Olumiant and Rinvoq that may have a connection to the February 2021 Xeljanz FDA Drug Safety Communication.
Recently we came across such a development that was reported in this March 18, 2021, BioPharma news report, "AbbVie's approval delay raises further concerns about JAK drugs". From the "Dive Brief" section of that BioPharma news report we get the following:
The Food and Drug Administration may take up to three months longer to review an application from AbbVie to get Rinvoq, its marketed medicine for rheumatoid arthritis, also approved to treat active psoriatic arthritis. The company now expects a decision toward the end of the second quarter.
AbbVie gave few details about the reasons for the delay in a Wednesday statement, noting only that the FDA had requested new information on the drug's benefits and risks in psoriatic arthritis patients. But after speaking with the company, Vamil Divan, an analyst at Mizuho Securities, learned the requests were for long-term safety data similar to what Pfizer recently showed for Xeljanz, a rival drug that works like Rinvoq.
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Just last month we posted these two articles about Xeljanz-associated heart problems and possible Xeljanz-related cancers:
- "Xeljanz FDA Drug Safety Communication in February 2021 Puts Heightened Scrutiny on Pfizer" (February 11, 2021); and,
"Xeljanz Has A New Drug Safety Issue, We Just Don't Know How Significant It Is, Yet" (February 17, 2021).
Our law firm is investigating Xeljanz lawsuits filed against Pfizer, the pharmaceutical company responsible for Xeljanz, with a focus on these adverse drug events and side effects related to Xeljanz:
Myocardial Infarction (MI)
Strokes — Ischemic / due to a blood clot
Deep Vein Thrombosis (DVT)
Pulmonary Embolism (PE)
Of course, we will be watching for further information from the Xeljanz safety clinical trial that showed Xeljanz-associated heart problems and possible Xeljanz-related cancers and which is the basis for the February 2021 Xeljanz FDA Drug Safety Communication. In addition, for the reasons stated above, we will monitor the safety profile of the JAK inhibitors Rinvoq and Olumiant going forward.
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