Tag: label change
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Syfovre Update: New Warnings About Retinal Vasculitis and/or Retinal Vascular Occlusion After Syfovre Injections
November 2023 Syfovre Label Change Comes After Earlier Reports of Eye Inflammation and Severe Vision Loss (Posted by Tom Lamb at Drug Injury Watch) UPDATE: From this February 28, 2024, Fierce Pharma news report, "Apellis cites…
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Ozempic: Reports of Gastrointestinal Disorder Ileus Added to Drug Label in September 2023
Paralytic Ileus, the Slowing of Food Movement Through Digestive System, is Similar to Intestinal Obstruction (Posted by Tom Lamb at Drug Injury Watch) In September 2023 the Ozempic (semaglutide) drug label was updated to inform…
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Lyrica Associated With Higher Risk Of Major Birth Defects When Taken During First Trimester Of Pregnancy According To Recent European Medical Study
Animal Studies Have Lyrica Possibly Linked To Skeletal Malformations, Neural Tube Defects, And Other Abnormalities, But Safety Data On Lyrica Use During Human Pregnancy Are Scarce (Posted by Tom Lamb at DrugInjuryWatch.com) …
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Will There Be Another Drug Label Change For YAZ And Other Drospirenone (DRSP) Birth Control Pills, As FDA Required For Ortho Evra Years Ago
Since Bayer Revised YAZ Label In April 2012 There Has Been More Medical Evidence That DRSP Pills Increase Risks Of Blood Clot Side Effects Like DVT And PE (Posted by Tom Lamb at…
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Diabetes Drugs Kombiglyze And Onglyza: Heart Failure Side Effect Seems To Be Valid, And FDA Notes There Is A Possible Increased Risk Of All-Cause Mortality
As Analysis Did Not Reveal Causes Of The Increase In Death Incidents, FDA Asks Its Advisory Committee To Discuss This Safety Issue At April 2015 Meeting (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: "AstraZeneca, Takeda Diabetes Drugs…
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Topamax Taken During Pregnancy Associated With A Significant Increased Risk Of Cleft Lip For Infants Born To Those Mothers
Recently Revised Topamax Label Includes Data Of 2014 Annual Report From The North American Antiepileptic Drug (NAAED) Pregnancy Registry (Posted by Tom Lamb at DrugInjuryWatch.com) By means of an October 21, 2014 FDA letter to Janssen Pharmaceuticals,…
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Serious Nerve Damage Side Effect Peripheral Neuropathy Associated With Levaquin, Cipro, And Avelox May Be A Permanent Drug Injury
An August 2013 Label Change Mandated By The FDA For All Fluoroquinolone Antibiotics Was Intended To Raise The Profile Of This Relatively Unknown Risk (Posted by Tom Lamb at DrugInjuryWatch.com) _________________________________________________________________________ UPDATE: Fluoroquinolone Antibiotics…
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Is Plavix-Related Hemophilia Side Effect Significant Enough For Label Change In Europe But Not In U.S.
Sanofi Has Sent Out "Dear Doctor" Letters About The Association Of Plavix (Clopidogrel) Acquired Hemophilia There — Why Not Here, Too (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: This label revision regarding hemophilia…
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Multaq Associated Lung Disease And Pulmonary Toxicity Pointed Out By New Safety Warnings In September 2012 Revised Label
Heart Drug Multaq Can Cause Pulmonary Fibrosis And Pneumonitis; Symptoms Are Inflammation Of The Lungs, Including Scarring And Thickening (Posted by Tom Lamb at DrugInjuryWatch.com) Multaq (dronedarone) is a drug used to treat abnormal heart rhythm (atrial…
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April 2012 Yasmin / YAZ Label Change: FDA Warns About Increased Risk Of Blood Clots Possible Due To Drospirenone
Beyaz, Safyral, Ocella, Gianvi, Zarah, Loryna, Syeda, And Vestura OC Pills Contain DRSP Progestin Also (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: Bayer's "Dear Doctor" Letter about April 2012 label change (PDF) for its…