Category: FDA Drug Safety Oversight
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Veozah Liver Injury Drug Safety Communication Issued by FDA in September 2024
August 2024 Veozah Drug Label Change Adds Warnings About Liver Toxicity and Abnormal Liver Tests (Posted by Tom Lamb at Drug Injury Watch) UPDATE: January 2025 Dear Healthcare Professional letter sent by Astellas Pharma Ltd. in…
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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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Prolia Increased Risk Of Hypocalcemia In Patients With Chronic Kidney Disease (CKD) Can Be 20-Times Higher Than Pills
Prolia "Black Box" Warning: Harm From Severe Hypocalcemia Ranges From Hospitalization For Life-threatening Events To Death (Posted by Tom Lamb at Drug Injury Watch) A January 2024 JAMA Original Investigation article, "Severe Hypocalcemia With Denosumab…
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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 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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Trulicity Recall Due to Dose Labeling Error Back in 2021 May Still be Drug Safety Issue Today
Thousands of Trulicity Autoinjector Devices Labeled as 0.75 mg Might Contain 1.5 mg (i.e., a “double-dose”) (Posted by Tom Lamb at Drug Injury Watch) A Trulicity recall back in August – September 2021 by Eli…
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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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Delsam Pharma’s Artificial Eye Ointment Recalled, Weeks After Artificial Tears Products Withdrawal
Updates About Bacterial Contamination Problem for These Over-The-Counter (OTC) Eye Products Given by FDA and CDC (Posted by Tom Lamb at Drug Injury Watch) On February 21, 2023, and February 22, 2023, there were updates…
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Artificial Tears Eye Drops Recall Involving EzriCare and Delsam Pharma’s Products in February 2023
Serious Infections Causing Vision Loss Have Been Linked to the Use of EzriCare Artificial Tears Lubricant Eye Drops (Posted by Tom Lamb at Drug Injury Watch) Today we pick up where our article from last…
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Copiktra Risk-Benefit Profile Update Following the Recent September 2022 FDA Advisory Committee Meeting
Issue: Whether Copiktra Risk-Benefit Profile is Still Favorable as a Third-Line CLL/SLL Cancer Treatment; Final Vote: "No" (Posted by Tom Lamb at Drug Injury Watch) We concluded our July 5, 2022 article, "Using Copiktra for…