Category: FDA Drug Safety Oversight
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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…
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Zantac Recall In April 2020 Comes 7 Months After The Zantac FDA Warning In September 2019
Level Of Chemical NDMA In Zantac Pills Can Cause Cancers: Pancreatic, Stomach, Colon, Rectal, Bladder, Kidney (Posted by Tom Lamb at DrugInjuryWatch.com) On April 1, 2020, the FDA announced that it was…
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Picato Skin Cancer Risk Findings Are Confirmed By European Drug Safety Panel In April 2020
FDA Investigation Of This Picato Drug Safety Issue Seems To Be Still Ongoing, Despite Picato Recall In Europe (Posted by Tom Lamb at DrugInjuryWatch.com) A European drug safety panel announced in April…
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Beovu Vision-Related Side Effects Warnings Label Change Request By Novartis: News Report
This Is A Reversal Of March 2020 Novartis Position That Current Beovu Drug Label Provided Sufficient Warnings (Posted by Tom Lamb at DrugInjuryWatch.com) According to an April 2020 news report, Novartis has…
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Lemtrada Cardiovascular Reactions Can Occur Within 1-3 Days Of Infusions In People Without Any Identifiable Risk Factors
Unpredictable And Potentially Fatal Immune-Mediated Reactions Can Occur Within Months And Up To At Least 4 Years After Lemtrada Treatments (Posted by Tom Lamb at DrugInjuryWatch.com) The UK Medicines and Healthcare Products…
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Beovu Side Effects Include Retinal Vasculitis, Eye Inflammation: Safety Issues For Macular Degeneration Drug
News Reports: There Have Been 11 Cases Of Beovu-Associated Occlusive Retinal Vasculitis, Which Can Lead To Blindness (Posted by Tom Lamb at DrugInjuryWatch.com) Several late February 2020 news articles report that the…
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Belviq Recall: FDA Warning Cancer Risks Of Diet Drug Belviq Outweigh Benefits — February 2020
Excess Cases Of Pancreatic Cancer, Colon Cancer, Rectal Cancer, And Lung Cancer Observed In Belviq Safety Clinical Trial (Posted by Tom Lamb at DrugInjuryWatch.com) On February 13, 2020 the FDA requested Eisai…
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Picato Skin Cancer Risk Investigation By European Drug Regulator Prompts Sales Suspension In Europe
January 2020 News Report: FDA “is gathering data and information to investigate the safety concern related to Picato” (Posted by Tom Lamb at DrugInjuryWatch.com) UPDATE: The UK’s Medicines and Health products Regulatory…
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Are Zantac NDMA Levels Increased By Heat Exposures During Shipping And Storage?
This Theory Would Explain Why NDMA Was Not Found To Be A Problem At Zantac Manufacturing Sites (Posted by Tom Lamb at DrugInjuryWatch.com) The fact that Zantac contains NDMA (nitrosamine impurity called…