Category: European Medicines Agency (EMA)
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Current FDA Safety Investigation: NAION With Mounjaro, Zepbound, and Other GLP-1 RAs
Evaluating Glucagon-like Peptide-1 (GLP-1) Receptor Agonists for Possible Risk of NAION Side Effects (Posted by Tom Lamb at Drug Injury Watch) The FDA has been investigating "potential signals" of non-arteritic anterior ischemic optic neuropathy (NAION)…
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Depo-Provera Drug Label Warnings in US Do Not Include Increased Risk of Intracranial Meningioma
While European Union (EU) and United Kingdom (UK) Drug Labels Have Warned About Meningioma for Many Years (Posted by Tom Lamb at Drug Injury Watch) Drug injury lawsuits that involve the contraceptive injection Depo-Provera being linked to…
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Novo Nordisk Semaglutide Drug Ozempic Linked to Vision Loss, Doubling the Risk: December 2024 Update
European Drug Regulators Are Investigating Semaglutide-Related NAION Cases Presented in Two Danish Studies (Posted by Tom Lamb at Drug Injury Watch) According to this December 18, 2024, Reuters news report, "Novo Nordisk's Ozempic faces EU…
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Syfovre Safety-Benefit Assessment by Europe’s Drug Regulator Differs From FDA
EMA’s CHMP Does Not Approve Syfovre for a Second Time, Citing "significant risk of adverse events" (Posted by Tom Lamb at Drug Injury Watch) There seems to be some disagreement about the Syfovre safety-benefit assessment…
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Ozempic Side Effects: Gallbladder Diseases, Thyroid Cancer, And Suicidal Thoughts
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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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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JAK Inhibitors Safety Review by European Drug Regulator EMA Announced in February 2022
Xeljanz, Rinvoq, and Olumiant as Treatments for Inflammatory Disorders Have Been Under Scrutiny by FDA in the US (Posted by Tom Lamb at Drug Injury Watch) In December 2021 there was a notable JAK inhibitors…
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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…