Tag: drug injury
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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 Safety Developments Presented by JAMA Ophthalmology Medical Journal in November 2021
Meanwhile, Still Waiting for the Anticipated Beovu Label Change That Was Previewed by Novartis Back in May 2021 (Posted by Tom Lamb at Drug Injury Watch) As the year 2021 draws to an end, we…
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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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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:…
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Xeljanz: Drug-induced Peripheral Neuropathy as Possible Xeljanz Side Effect in 2 RA Patients
Reports of Rheumatoid Arthritis Patients on Xeljanz Experiencing Secondary Neurological Adverse Events (Posted by Tom Lamb at Drug Injury Watch) As we have written about previously, according to the FDA, some of the generally recognized…