Tag: safety signal
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Syfovre Retinal Vasculitis And Severe Intraocular Inflammation Cases Reported By Ophthalmologists
A July 2023 "Dear Doctor" Letter From Apellis Acknowledges This Developing Syfovre Safety Signal Situation (Posted by Tom Lamb at Drug Injury Watch) UPDATE: From this February 28, 2024, Fierce Pharma news report, "Apellis cites current…
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Ozempic Side Effects: Gallbladder Diseases, Thyroid Cancer, And Suicidal ThoughtsÂ
Diabetes and Weight-Loss Drug Ozempic Getting Scrutiny From European Drug Safety Regulator EMA ***See also: Ozempic Severe Gastric Side Effects Include Stomach Paralysis, Gastroparesis, And Intestinal Blockages (Posted by Tom Lamb at Drug Injury Watch)…
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Prolia – Hypocalcemia Side Effect Safety Signal May Draw Regulatory Action by FDA
"Risk of severe hypocalcemia" in Patients on Dialysis Receiving Osteoporosis Drug Prolia (denosumab) (Posted by Tom Lamb at Drug Injury Watch) The FDA is in the process of evaluating the osteoporosis drug Prolia (denosumab) to…
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Ukoniq Lymphoma Drug Safety Investigation Started In February 2022 to Examine Increased Risk of Death
FDA Oncologic Drugs Advisory Committee Meeting in Near Future May Consider Possible Ukoniq Drug Recall (Posted by Tom Lamb at Drug Injury Watch) UPDATE: Ukoniq Drug Recall in April 2022 Comes Soon After FDA Warning…
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Possible FDA Advisory Committee Meeting for Xeljanz, Rinvoq, and Other Janus Kinase (JAK) Inhibitors
Outside Experts Could Review All JAK Inhibitors Risk/Benefit Profiles as Regards Several Requested New Indications (Posted by Tom Lamb at Drug Injury Watch) A few months ago we wrote about a possible FDA Advisory Committee…
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How Electronic Medical Records Review Might Help FDA Identify Unsafe Drugs Sooner
Study Says Using Such Data Would Have Resulted In Faster Safety Signal Detection For Increased Risk Of Heart Attacks With Avandia Use (Posted by Tom Lamb at DrugInjuryWatch.com) A recent medical journal article suggests…