Tag: FDA
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New FDA Regulatory Action for Ukoniq Recall First Announced by Drug Company in April 2022
June 2022 FDA Drug Safety Communication Makes Clear That Ukoniq Was Removed From Market Due to Safety Issues (Posted by Tom Lamb at Drug Injury Watch) On June 1, 2022, the FDA issued an update…
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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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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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Picato May Increase The Risk Of Skin Cancer As Side Effect, Says Drug Regulator Health Canada In July 2020
Picato Skin Cancer Risk Has Been Confirmed By European Drug Regulator; The FDA Is Still Investigating This Picato Safety Issue (Posted by Tom Lamb at DrugInjuryWatch.com) The topical gel drug Picato (ingenol…
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Beovu Label Change: Warnings About Possible Permanent Vision-Loss Side Effects Added In June 2020
Beovu Use Increased Risks Of Retinal Vasculitis And Retinal Vascular Occlusion, Which Can Lead To Blindness (Posted by Tom Lamb at DrugInjuryWatch.com) In early June 2020, the FDA approved a label update…