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...]
Drug Regulator MHRA Imposes More Xeljanz Use Limitations in October 2021
In this Drug Safety Update document, “Tofacitinib (Xeljanz▼): new measures to minimise risk of major adverse cardiovascular events and malignancies”, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) took new regulatory action regarding the Xeljanz risk of cardiovascular events as well as the Xeljanz risk of cancers, or … [Read more...]
Possible New Xeljanz Side Effect: Peripheral Neuropathy
As reported in this Letters to the Editor item, “Tofacitinib and Risk of Peripheral Neuropathy? Experience of 2 Cases in Patients With Rheumatoid Arthritis”, patients treated with Xeljanz (tofacitinib) for their rheumatoid arthritis (RA) may be at risk of neurological adverse events, such as Xeljanz-related peripheral neuropathy. That item about … [Read more...]
Xeljanz: Heart Attacks, Strokes, Cancers, Blood Clots, and Deaths – Updated FDA Warnings 2021
On September 1, 2021, we saw new FDA Xeljanz warnings about the increased risks of heart attacks, strokes, cancer, blood clots, and deaths. These Xeljanz drug safety problems have been associated with all doses of Xeljanz (5 mg tablet and 10 mg tablet) and Xeljanz XR (11 mg tablet and 22 mg tablet). This September 2021 document, “FDA requires … [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...]
Some Information About Our Monthly Law Firm Newsletter
The Lamb Law Office Newsletter is a monthly communication from our law firm to help keep you up to date with some of the cases that we are working on for clients at the present time. In addition, we provide at least one information resource item per month, which you or someone you know might find helpful from time to time. Past … [Read more...]