Tag: FDA Drug Safety Communication
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Tavneos Liver Injury Drug Safety Communication Issued by FDA in Late March 2026
Just 2 Months Earlier, Amgen Refused an FDA Request to Withdraw Tavneos; Will There Be a Tavneos Recall Soon? (Posted by Tom Lamb at Drug Injury Watch) On March 31, 2026, the FDA issued a Tavneos liver…
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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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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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Using Copiktra for Leukemia or Lymphoma May Increase Risks of Serious Side Effects and Death
Future FDA Advisory Committee Meeting Will Discuss Whether Copiktra Should be Used as CLL or SLL Treatment (Posted by Tom Lamb at Drug Injury Watch) As background, Copiktra (duvelisib) was approved by the FDA in…
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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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Xeljanz FDA Drug Safety Communication in February 2021 Puts Heightened Scrutiny on Pfizer
One wonders how the FDA might react to this continued “direct to consumer” advertising for Xeljanz which Pfizer is (still) sponsoring after the February 2021 FDA Xeljanz Drug Safety Communication about Xeljanz causing heart…
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Lemtrada Review By European Drug Regulatory Agency Covers Various Serious Side Effects In MS Patients
EMA Will Investigate Reports Of Associated Conditions Beyond Those That Were In November 2018 FDA Drug Safety Communication (Posted by Tom Lamb at DrugInjuryWatch.com) We recently learned by means of this April…