Category: FDA Drug Safety Oversight
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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…
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A “Dear Doctor” Letter For Invokana Amputations Side Effect Was Sent September 2017 By Janssen In Canada
In US There Was A “Black-Box Warning” Added On Revised Drug Label Issued In July 2017 But Without Any Such Letter, It Seems (Posted by Tom Lamb at DrugInjuryWatch.com) The “FDA Drug…
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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,…
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Analysis Of FDA Adverse Event Reports Describes Extent And Nature of Invokamet / Invokana – Amputation Side Effect
This New Medical Research Was Published Just Before “Black-Box Warning” About Lower Limb Amputations Added To Drug Labels (Posted by Tom Lamb at DrugInjuryWatch.com) In the final week of July 2017, the…
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European Drug Regulator EMA Suspends Use Of MRI Drugs Magnevist, Omniscan, And OptiMARK In July 2017
The Drug Safety Concern Is That Use Of These Gadolinium Contrast Agents Can Leave Gadolinium Deposits In Brain Tissues (Posted by Tom Lamb at DrugInjuryWatch.com) The European Medicines Agency (EMA) recently announced…
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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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Keytruda, Opdivo, And Yervoy May Be Associated With Vision Loss And Retinal Detachment In Addition To Uveitis
In June 2017 The FDA Announced It Is Evaluating Possible Drug Label Changes And The Need For Other Regulatory Actions (Posted by Tom Lamb at DrugInjuryWatch.com) According to the document “Potential Signals…
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Despite The High Number Of Actemra – Pancreatitis Cases Reported To FDA, No Warning Added To Drug Label
June 2017 Investigative Article Published By STAT Calls Into Question FDA Oversight After Drugs Are Approved By Agency (Posted by Tom Lamb at DrugInjuryWatch.com) Actemra (tocilizumab) is approved by the FDA for…
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There Is Continuing Concern About Whether Victoza Is Associated With Pancreatic Cancer As A Possible Side Effect
The FDA Briefing Materials For A June 2017 Advisory Committee Meeting On Victoza Include A Discussion Of This Safety Issue (Posted by Tom Lamb at DrugInjuryWatch.com) On June 20, 2017 there will…
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Growing Concern About Reports Of Children Who Developed Neuro-Psychiatric Problems After Taking MiraLAX
FDA-Funded Study About The Use Of Polyethylene Glycol In The Pediatric Population Currently Underway At Children's Hospital Of Philadelphia (Posted by Tom Lamb at DrugInjuryWatch.com) MiraLAX is a popular over-the-counter laxative medicine…