Category: Drug Safety Alerts
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JAK Inhibitors Safety Review by European Drug Regulator EMA Announced in February 2022
Xeljanz, Rinvoq, and Olumiant as Treatments for Inflammatory Disorders Have Been Under Scrutiny by FDA in the US (Posted by Tom Lamb at Drug Injury Watch) In December 2021 there was a notable JAK inhibitors…
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Ukoniq Lymphoma Drug Safety Investigation Started In February 2022 to Examine Increased Risk of Death
FDA Oncologic Drugs Advisory Committee Meeting in Near Future May Consider Possible Ukoniq Drug Recall (Posted by Tom Lamb at Drug Injury Watch) UPDATE: Ukoniq Drug Recall in April 2022 Comes Soon After FDA Warning…
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Xeljanz Safety Study Final Data Details the Increased Risks of Cancers and Major Adverse Cardiovascular Events
January 2022 Medical Journal Article Presents Full Set of Findings for the Xeljanz "ORAL Surveillance" Trial Which Started in 2014 (Posted by Tom Lamb at Drug Injury Watch) One year ago Pfizer released some preliminary…
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Beovu Drug Label Change in December 2021 Adds More Information About Vision Loss Side Effects
Provides "risk factors and possible mechanism" for Beovu-related Retinal Vasculitis and Retinal Vascular Occlusion (Posted by Tom Lamb at Drug Injury Watch) Update: "Novartis Finally Issues Revised Beovu Prescribing Information for US in February 2022"…
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December 2021 JAK Inhibitors Drug Class Label Changes: More Warnings and Use Restrictions
Risks of Cancers, Blood Clots, Heart Problems, and Deaths Associated with Xeljanz, Olumiant, and Rinvoq (Posted by Tom Lamb at Drug Injury Watch) As background, in September 2021 the FDA announced that it was requiring…
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Eli Lilly Attempts to Distance Olumiant From the Ominous JAK Inhibitors Drug Class Safety Issues Flagged by FDA
Xeljanz, Rinvoq, and Olumiant Are the Three Janus Kinase (JAK) Inhibitors Getting "Black-Box" Warnings Revisions, Soon (Posted by Tom Lamb at Drug Injury Watch) In September 2021 the FDA announced it was requiring revisions to…
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Two Padcev SJS / TEN Case Reports Published Before March 2021 Padcev Label Change About These Skin Reactions
When Astellas Pharma First Knew About SJS / TEN Side Effects Is A Key Fact In This Still Developing Padcev Drug Safety Issue (Posted by Tom Lamb at Drug Injury Watch) About a month ago,…
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Xeljanz Risks of Cardiovascular Events, as Well as Cancers, Cause More Xeljanz Use Limitations
October 2021 UK’s MHRA Xeljanz Action Follows September 2021 FDA Xeljanz Drug Safety Communication Update (Posted by Tom Lamb at Drug Injury Watch) On September 1, 2021, we posted this article, “Xeljanz: FDA Warnings Updated:…