Category: FDA Drug Safety Oversight
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Byetta, Trulicity, Ozempic, and Adlyxin Linked to Gallbladder Disease Side Effects, Including Deaths
36 Cases of Acute Cholecystitis in Patients Taking Glucagon-like Peptide-1 (GLP-1) Receptor Agonists in FDA FAERS (Posted by Tom Lamb at Drug Injury Watch) A recent Research Letter written by three FDA employees with the…
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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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New FDA Regulatory Action for Ukoniq Recall First Announced by Drug Company in April 2022
June 2022 FDA Drug Safety Communication Makes Clear That Ukoniq Was Removed From Market Due to Safety Issues (Posted by Tom Lamb at Drug Injury Watch) On June 1, 2022, the FDA issued an update…
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Ukoniq Drug Recall in April 2022 Comes Soon After FDA Warning About Increased Risk of Death in February 2022
This "New" Lymphoma Drug Had Only Been on the Market Since February 2021, When Ukoniq Received FDA Accelerated Approval (Posted by Tom Lamb at Drug Injury Watch) In February 2022 we wrote about this Drug…
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Ukoniq FDA Advisory Committee Meeting in April 2022 Will Evaluate Ukoniq Drug Safety Findings
FDA Has Been Investigating Ukoniq for an Increased Risk of Death in Lymphoma Cancer Patients Treated With Ukoniq (Posted by Tom Lamb at Drug Injury Watch) UPDATE: Ukoniq Drug Recall in April 2022 Comes Soon After…
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How People Can Report Adverse Drug Reactions to the FDA, and What Happens to This Information Thereafter
From time to time we hear from people who want to know: (1) How they can report a serious prescription drug side effect, or adverse drug reaction, to the FDA; and, (2) What happens…
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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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December 2021 JAK Inhibitors Drug Class Label Changes: More Warnings and Use Restrictions
Risks of Cancers, Blood Clots, Heart Problems, and Deaths Associated with Xeljanz, Olumiant, and Rinvoq (Posted by Tom Lamb at Drug Injury Watch) As background, in September 2021 the FDA announced that it was requiring…
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Eli Lilly Attempts to Distance Olumiant From the Ominous JAK Inhibitors Drug Class Safety Issues Flagged by FDA
Xeljanz, Rinvoq, and Olumiant Are the Three Janus Kinase (JAK) Inhibitors Getting "Black-Box" Warnings Revisions, Soon (Posted by Tom Lamb at Drug Injury Watch) In September 2021 the FDA announced it was requiring revisions to…