From this June 30, 2022, FDA Drug Safety Communication, "FDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib)", we get the following: To evaluate the long-term safety of Copiktra, we required the drug manufacturer, Secura Bio, to submit the … More
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Recent News & Case Reports
Xalkori Side Effects: Children Suffering Ocular Toxicity and Severe Visual Loss
A June 14, 2022, European Pharmaceutical Review (EPR) article about the most recent meeting of EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) reports a new drug safety issue involving Xalkori-related vision disorders found in clinical trials for pediatric patients treated with … More
Ukoniq Death Risk is Reason for Ukoniq Drug Recall Says FDA
This June 1, 2022 document, "Drug Safety Communication: FDA approval of lymphoma medicine Ukoniq (umbralisib) is withdrawn due to safety concerns", makes clear it is the Ukoniq death risk that was behind the recent Ukoniq drug recall: Due to safety concerns, the U.S. Food and Drug Administration … More
Drug Injury Research: FDA Resources Online Available for Patients
In order to make sure that you are using credible sources if and when you want to do some drug injury research, there is an FDA information site and an FDA database that is searchable which we want you to know are available online. (1) Drug Safety Communications This webpage was developed to … More
Ukoniq Was Pulled From Market Due to Increased Risk of Patient Deaths
The drug company responsible for the lymphoma medicine Ukoniq (umbralisib), TG Therapeutics, indicated in April 2022 that Ukoniq was pulled from the market due to an increased risk of death in patients using Ukoniq. This April 15, 2022 Dow Jones piece, "TG Therapeutics Pulls Sole Product Ukoniq … More
MS Drugs Ocrevus and Gilenya Linked to Melanoma, Other Skin Cancers
Multiple sclerosis (MS) drugs Ocrevus and Gilenya have been linked to melanoma, with Gilenya linked to squamous cell carcinoma and basal cell carcinoma, also. These new drug safety findings come from an analysis of skin cancers reported to the FDA Adverse Event Reporting System (FAERS) for patients … More