Category: FDA Drug Safety Oversight
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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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Padcev Skin Reaction Side Effects SJS and TEN: From No Warning to “Black Box” in Less Than 2 Years
Bladder Cancer Drug Padcev is Linked to Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) in 2021 (Posted by Tom Lamb at Drug Injury Watch) Padcev (enfortumab vedotin-ejfv), an injection drug for intravenous use, was…
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Xeljanz: FDA Warnings Updated: There are Higher Rates of Blood Clots and Deaths for Both Doses of Xeljanz, Now
JAK Inhibitors Xeljanz, Olumiant, and Rinvoq Get Drug Label Changes and Drug Use Limitations in September 2021 (Posted by Tom Lamb at Drug Injury Watch) On September 1, 2021, the FDA released this alerting news…
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Possible FDA Advisory Committee Meeting for Xeljanz, Rinvoq, and Other Janus Kinase (JAK) Inhibitors
Outside Experts Could Review All JAK Inhibitors Risk/Benefit Profiles as Regards Several Requested New Indications (Posted by Tom Lamb at Drug Injury Watch) A few months ago we wrote about a possible FDA Advisory Committee…
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Belviq Recall Aftermath: Further FDA Action in 2021 Means There Will Be No Belviq Generic Drugs
Belviq Was Withdrawn From Market Due to Increased Risk of Certain Cancers: Pancreatic, Colon, Rectal, And Lung (Posted by Tom Lamb at Drug Injury Watch) Recently we found some further FDA action…