Category: Drug Safety Alerts
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Valtrex Associated With Serious Skin Reaction DRESS Side Effect That Can Be Fatal, Says Health Canada
Canadian Product Monograph for Valtrex Now Warns About Risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) (Posted by Tom Lamb at Drug Injury Watch) Valtrex (valacyclovir) is a long-established treatment for cold sores,…
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Tepezza Hearing Side Effects Include Deafness, Sound Sensitivity, and Tinnitus, Resulting in Tepezza Drug Injury Lawsuits
Tepezza Linked to Hypoacusis, Hyperacusis, Autophony, Other Hearing Problems Which May be Irreversible and Permanent (Posted by Tom Lamb at Drug Injury Watch) Tepezza is a relatively new treatment for Thyroid Eye Disease, approved by…
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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…
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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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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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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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Multiple Sclerosis (MS) Drugs Gilenya and Ocrevus Associated With a Higher Likelihood of Melanoma Skin Cancer
Other MS Treatments Such as Lemtrada and Mayzent May Have an Increased Risk of Basal Cell Carcinoma and Squamous Cell Carcinoma (Posted by Tom Lamb at Drug Injury Watch) An analysis of skin cancers reported…