Tag: drug injury
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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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First Monotherapy Ocrevus PML Case Report: Patient Used Ocrevus for 2 Years Without Prior Immunotherapy
Compare 9 Earlier Cases of PML in MS Patients After Ocrevus Treatments: Those Involved Previous Tysabri and/or Gilenya Use (Posted by Tom Lamb at Drug Injury Watch) Pharmaceutical company Genentech knew about the first monotherapy…
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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Belviq Was Withdrawn From Market Due to Increased Risk of Certain Cancers: Pancreatic, Colon, Rectal, And Lung (Posted by Tom Lamb at Drug Injury Watch) Recently we found some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…
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Xeljanz FDA Drug Safety Communication in February 2021 Puts Heightened Scrutiny on Pfizer
One wonders how the FDA might react to this continued “direct to consumer” advertising for Xeljanz which Pfizer is (still) sponsoring after the February 2021 FDA Xeljanz Drug Safety Communication about Xeljanz causing heart…
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Elmiron Maculopathy Secondary to Pentosan Polysulfate (PPS) Toxicity: Medical Journal Article
New Elmiron Study Suggests Established Maculopathy Patients Should be Asked About Possible Elmiron Use (Posted by Tom Lamb at Drug Injury Watch) Elmiron maculopathy secondary to pentosan polysulfate (PPS) toxicity was first…
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Gilenya Liver Injury Risk Warnings Are Increased, Again, This Time in Canada
Similar Gilenya Drug Label Changes Were Made in Europe and UK During Past Few Months (Posted by Tom Lamb at Drug Injury Watch) On January 18, 2021 Health Canada posted a Gilenya…