Risks of Cancers, Blood Clots, Heart Problems, and Deaths Associated with Xeljanz, Olumiant, and Rinvoq
As background, 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." (See: "FDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions")
Before going into some commentary found in news reports about the effects of this December 2021 JAK inhibitors drug class safety development, 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)
Xeljanz is a Pfizer drug, Rinvoq is an AbbVie drug, and Olumiant is an Eli Lilly drug. As we wrote about in this recent article, "Eli Lilly Attempts to Distance Olumiant From the Ominous JAK Inhibitors Drug Class Safety Issues Flagged by FDA", the pharmaceutical companies AbbieVie and Eli Lilly have attempted to distinguish the safety profile of their respective JAK inhibitors drug product from the various adverse drug reactions that have been observed in the Xeljanz clinical trial that have driven the FDA regulatory actions driving these December drug label changes.
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One pharmaceutical industry commentator thinks that AbbVie may have an advantage in "market share" going forward as regards the three JAK inhibitors drugs approved for the treatment of rheumatoid arthritis, given some details of the new drug label for Rinvoq. From this December 6, 2021, Fierce Pharma news report, "AbbVie's Rinvoq, Pfizer's Xeljanz and Lilly's Olumiant slapped with new FDA warnings amid JAK safety crackdown", we get the following:
Rinvoq appears to have got what [SVB Leerink analyst Geoffrey Porges] called “milder language” on the risks. The new Rinvoq boxed warning specifies that the higher rates of the safety problems over TNF blockers are observed in another JAK inhibitor. What’s more, there were no restrictions on how long a patient can take Rinvoq.
The somewhat better-than-expected wording will “make a modest difference” only to new physicians or those who aren’t familiar with JAKs, he said in a Monday note.
Nevertheless, Porges believes Rinvoq is in a better position than the other two JAK inhibitors “given the strength of the data and AbbVie’s well-entrenched position in immunology.” Plus, no other drug regulators outside the U.S. have posted similar restrictions, he noted.
For a similar viewpoint, we move to this December 6, 2021, Evaluate Vantage piece, "New label warnings raise hopes for Jak safety closure", which also indicates that this December 2021 JAK inhibitors drug class FDA regulatory action could have been worse:
The full fallout from the FDA’s safety review of the Jak inhibitors remains unknown, amid concerns about moves to curb these drugs’ use drastically. But two label updates that emerged late Friday are raising hopes that draconian measures are off the table. Abbvie and Pfizer announced new boxed warnings for their respective products, Rinvoq and Xeljanz. These black boxes now highlight the higher rate of major adverse cardiac events seen versus anti-TNF agents in the Oral Surveillance trial of Xeljanz. As expected, both have also had rheumatoid arthritis indications scaled back, with patients required to have failed at least one TNF blocker. Analysts believe that Abbvie has come off as well as could be expected, with the label wording making it clear that the [major adverse cardiovascular events (MACE)] signal was seen with “another Jak inhibitor”, and no restrictions on duration of use; some were expecting harsher action from the regulator.
We will continue to monitor the pharmaceutical regulatory sector as well as the medical literature for future developments as regards the increased risks of cancers, blood clots, heart problems, and deaths associated with Xeljanz, Olumiant, and Rinvoq.
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