Tag: drug safety warnings
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Xalkori Vision Side Effects for Pediatric Patients in Clinical Trials Were Seen at an Alarming Rate, Says EMA
Drug Safety Warning: Xalkori-Related Ocular Toxicity and Severe Visual Loss are Difficult to Detect in Children (Posted by Tom Lamb at Drug Injury Watch) Xalkori (crizotinib) is approved by the FDA for the treatment of:…
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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…
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European Medicines Agency (EMA) Warns Xeljanz Increases Risk Of Pulmonary Embolism (PE) And Deep Vein Thrombosis (DVT)
Recommends That Xeljanz Should Be Used With Caution In Patients At High Risk Of Blood Clots As Well Aa In Patients Older Than 65 Years Of Age (Posted by Tom Lamb at DrugInjuryWatch.com)…
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Uloric Use By Patients With Major Cardiovascular Disease Associated With Higher Risk Of Deaths
New Drug Safety Warning: Uloric Should Be Avoided When There Is Prior Myocardial Infarction, Stroke, Or Unstable Angina (Posted by Tom Lamb at DrugInjuryWatch.com) From this Drug Safety Update issued July 17,…
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June 2019 Actemra Label Change Adds Warnings About Increased Risks Of Liver Injury After Months Or Years Of Use
Serious Cases Of Hepatic Injury Some Of Which Have Resulted In Liver Transplant Or Death Reported As Side Effects (Posted by Tom Lamb at DrugInjuryWatch.com) On May 21, 2019 we posted this…
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Risk Of Actemra Associated Liver Injury Being Assessed By Health Canada, With Drug Label Change Likely To Follow
Drug-Induced Liver Injuries Reported In Patients Using Actemra, Including Cases Of Acute Liver Failure Requiring A Transplant (Posted by Tom Lamb at DrugInjuryWatch.com) In May 2019 we learned that Actemra has been…
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Uloric Drug Safety Update: A Significantly Higher Risk Of Death Among Patients Using Gout Drug Uloric As Opposed To Allopurinol
Recent Findings Come From The CARES Trial, A Postmarketing Safety Study Requested By FDA Back When Uloric Was Approved In 2009 (Posted by Tom Lamb at DrugInjuryWatch.com) At the recent American College…
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Drug-Induced Liver Injury Warning Added To OFEV Label In Canada As Done Earlier In US
This Relatively New Idiopathic Pulmonary Fibrosis (IPF) Pill Is Clearly On The Radar Of Drug Safety Regulators (Posted by Tom Lamb at DrugInjuryWatch.com) OFEV (nintedanib) capsules were approved by the FDA in 2014…
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Invokana – Amputation Side Effect Gets “Black-Box Warning” On Revised Drug Label Issued In July 2017
This Label Change Was Previewed In A May 2017 FDA Drug Safety Communication About Increased Risk Of Leg And Foot Amputations (Posted by Tom Lamb at DrugInjuryWatch.com) A June 2017 article, “Invokana…
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Pending Motion Requests Multidistrict Litigation (MDL) For Farxiga And Xigduo XR Lawsuits Filed In Federal Court
These New Diabetes Drugs Have Increased Risks Of Serious Side Effects Such As Diabetic Ketoacidosis (DKA) And Acute Kidney Injury (Posted by Tom Lamb at DrugInjuryWatch.com) Farxiga (dapagliflozin) and Xigduo XR (dapagliflozin…