Tag: label changes
-
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…
-
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…
-
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…
-
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…
-
Newer Diabetes Drugs Side Effect: Fournier’s Gangrene, Serious Infection Of Genital Area
FDA Mandates Label Changes With New Warnings For Invokana, Farxiga, Jardiance, Other SGLT2 Inhibitors (Posted by Tom Lamb at DrugInjuryWatch.com) In late August 2018 the FDA warned doctors and patients that cases…
-
Rexulti Warnings For Compulsive Behavior And Impulse Control Problems Added To Drug Label
FDA: Patients Using Rexulti At Risk For Experiencing Intense Urges For Gambling And Inability To Control Conduct (Posted by Tom Lamb at DrugInjuryWatch.com) Rexulti® (brexpiprazole) was initially approved by the FDA in…
-
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…
-
New Heart Failure Drug Entresto Apparently Has Safety Signal For Hypotension (Low Blood Pressure) Side Effect
Will Recent ISMP QuarterWatch Report Prompt FDA Regulatory Action, Including Possible Drug Label Change By Novartis? (Posted by Tom Lamb at DrugInjuryWatch.com) The FDA approved Entresto™ (sacubitril and valsartan) tablets in July…
-
Will Ocaliva Get Black-Box Warning For Liver Injury Side Effects After September 2017 FDA Report?
19 Patients Have Died While Using This New Liver Disease Drug, Some When Prescribed Higher-Than-Recommended Doses (Posted by Tom Lamb at DrugInjuryWatch.com) UPDATE: “FDA adds Boxed Warning to highlight correct dosing of Ocaliva…
-
August 2017 ED Drugs Label Change Warns That Some Users Of Cialis, Levitra, And Viagra Have Developed NAION Vision Loss
There Is An Approximate Two Times Increased Risk Of NAION According To Recent Medical Study, Which Is Consistent With Some Earlier Medical Research (Posted by Tom Lamb at DrugInjuryWatch.com) As reported previously,…