Olumiant (baricitinib), Xeljanz (tofacitinib), and Rinvoq (upadacitinib) are the three 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. … More
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Recent News & Case Reports
Two Padcev-induced TEN / SJS Cases Where Patient Died From Their Padcev Side Effects
We continue to monitor the medical literature for any Padcev skin reaction case report involving toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS). In this post, we cover two Padcev-induced TEN / SJS cases where the patient died from their Padcev side effects. We start with a … 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 … More
Imbruvica Heart-Related Side Effects and Cardiotoxicity Safety Issues
In this article, we point out a few of the medical news reports about heart-related Imbruvica side effects that have been published in the past 12 months. First, there is this November 2020 Healio article, "Link between ibrutinib-related hypertension, heart problems necessitates close … 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 … More
Padcev Linked to SJS and TEN: From No Warning to “Black Box” in Less Than 2 Years
We are going to look at how the Padcev drug label went from having no warning about Padcev skin side effects Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) when approved by the FDA in December 2019 to the Padcev drug label having a "Black-Box" warning about the SJS and TEN skin … More