Category: FDA Drug Safety Oversight
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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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Picato Recalls Continue with Canada and Denmark Being Most Recent, All Due to Risk of Skin Cancer
A Global Phase-out of Picato Sales by LEO Pharma Inc. Due to this Picato Safety Finding Expected by End of 2020 (Posted by Tom Lamb at DrugInjuryWatch.com) But first, we get…
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Ocaliva FDA Adverse Events Reports for Hepatobiliary System Cases: An Analysis as of October 2020
Lack of Warnings in Current Ocaliva Drug Label for Some Serious Side Effects Involving Liver, Gallbladder, Bile Ducts (Posted by Tom Lamb at DrugInjuryWatch.com) We are still wondering how the current FDA…
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Potential Ocaliva – Liver Disorder Safety Signal Being Investigated by FDA as Side Effects Risk
October 2020 News Report Reveals "New" Ocaliva Liver Safety Issue, Which Had Been Under the Radar Previously (Posted by Tom Lamb at DrugInjuryWatch.com) Ocaliva (obeticholic acid) was approved by the FDA in…
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Report on FDA Belviq Recall Decision Provides New Information About Excess Cancers Risks
Belviq Safety Data Review Found Higher Rates of Colorectal Cancer, Pancreatic Cancer, and Lung Cancer (Posted by Tom Lamb at DrugInjuryWatch.com) The FDA's decision to request that the pharmaceutical company Eisai recall…
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Drug Safety Issue: Elmiron Side Effects Risks for Eye and Vision Appear to be Greater Than Bladder Treatment Benefits
Patients Consider Whether Relief from Bladder Pain is Worth Possibility of Elmiron-Associated Maculopathy and Other Eye Problems (Posted by Tom Lamb at DrugInjuryWatch.com) Approved by the FDA way back in 1996, Elmiron…
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Vascular Endothelial Growth Factor (VEGF) Inhibitors: Increased Risk Of Aneurysm And Artery Dissection
New Warnings Added To Drug Labels For All VEGF Inhibitors By UK's MHRA Already; FDA Is Evaluating Need For Regulatory Action (Posted by Tom Lamb at DrugInjuryWatch.com) On July 31, 2020 the…
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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…