This excerpt from the “Advisory – Health Canada safety review finds link between the use of Xeljanz and Xeljanz XR (tofacitinib) and increased risk of serious heart-related issues and cancer” issued in January 2022 provides an overview of the Xeljanz drug safety issue, and how the Xeljanz side effects risks may also apply to Olumiant and … [Read more...]
Cancers, Blood Clots, Heart Problems, and Deaths Associated with Xeljanz, Olumiant, and Rinvoq
We continue to monitor the pharmaceutical regulatory sector as well as the medical literature for developments as regards the increased risks of cancers, blood clots, heart problems, and deaths associated with Xeljanz, Olumiant, and Rinvoq. In December 2021 there was another JAK inhibitors drug class safety development, with Xeljanz, Olumiant, … [Read more...]
Olumiant or Xeljanz: Is One of These JAK Inhibitor Drugs Safer?
Olumiant (baricitinib) and Xeljanz (tofacitinib) are the two Janus kinase (JAK) inhibitors currently approved by the FDA for the treatment of arthritis and other inflammatory conditions. In September 2021 the FDA announced a JAK inhibitors drug class label change. Specifically, the FDA is requiring revisions to the “Black-Box” warnings for Olumiant … [Read more...]
FDA Advisory Committee Meeting Could Review Risk/Benefit Profiles for All JAK Inhibitors
The FDA has delayed its decision for Abbvie’s applications to have Rinvoq approved for the additional indications of psoriatic arthritis and ankylosing spondylitis, apparently due to possible new JAK inhibitors heart side effects and cancer risks issues identified in connection with a Xeljanz safety signal. From this June 25, … [Read more...]
Possible FDA Advisory Committee Meeting for Xeljanz, Olumiant, and Rinvoq in Future
Based on these several recent developments, we expect that there will be an FDA Advisory Committee Meeting for Xeljanz, Olumiant, and Rinvoq in the months to come. The focus of such will likely be these adverse drug events and side effects related to the JAK inhibitors class of drugs: Heart AttacksMyocardial Infarction (MI)Strokes — Ischemic / … [Read more...]
Are Heart Problems and Cancers JAK Inhibitors Drug Class Safety Issues?
Since the February 2021 FDA alert about Xeljanz-associated heart problems and possible Xeljanz-related cancers was issued, we have been watching for any related drug safety developments concerning Olumiant and Rinvoq. The reason being there has been some concern that those adverse drug events and side effects risks may apply to those other two … [Read more...]