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 and vision loss found in clinical trials for pediatric patients treated with Xalkori. In relevant part from this EPR article about the EMA’s PRAC … [Read 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This June 1, 2022 document, “Drug Safety Communication: FDA approval of lymphoma medicine Ukoniq (umbralisib) is withdrawn due to safety concerns”, makes clear it is the Ukoniq death risk that was behind the recent Ukoniq drug recall: Due to safety concerns, the U.S. Food and Drug Administration (FDA) has withdrawn its approval for the cancer … [Read more...]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 provide the public with easy access to important drug … [Read more...]
Ukoniq Withdrawn From Market Due to Increased Risk of Patient Deaths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responsible for the lymphoma medicine Ukoniq (umbralisib), TG Therapeutics, indicated in April 2022 that Ukoniq was withdrawn from the market due to an increased risk of death in patients using Ukoniq.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 Amid Increased Death Risk”, summarizes why … [Read 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 cancer cases reported to the FDA Adverse Event Reporting System (FAERS) for patients receiving certain multiple sclerosis (MS) … [Read more...]
Fosamax Lawsuits Dismissed Again by March 2022 Preemption Ruling
There are about 500 women who used Fosamax, suffered femur fractures, and then filed a product liability lawsuit against Merck. Their lawsuit had been pending in the federal court Fosamax MDL for ten years or more. In an unfortunate but not altogether unexpected development, in March 2022 their Fosamax lawsuits were dismissed a second time as a … [Read more...]
April 2022 FDA Advisory Committee Meeting For Ukoniq Risk of Death
We first learned from this March 10, 2022 press release item, “TG Therapeutics Announces Scheduling of Planned Oncologic Drug Advisory Committee Meeting”, that the Ukoniq FDA Advisory Committee meeting will be held on April 22, 2022. This development relates back to a Drug Safety Communication, “FDA investigating possible increased risk of death … [Read more...]
Beovu Label Change: Novartis Adds Information, Increases Safety Warnings in February 2022
We had been watching for a second Beovu label change since May 2021, when Novartis stopped three Beovu clinical trials for safety reasons, and, at the same time, said it would update the Beovu drug label. Finally, in February 2022, Novartis added information and increased safety warnings about various Beovu eye-related side effects, such as retinal … [Read more...]
How People Can Report Adverse Drug Reactions to the FDA MedWatch Program
MedWatch is an FDA program for reporting “serious reactions” resulting from a prescription medication. The FDA is particularly interested in those drug injury events which resulted in any of the following outcomes: Patient's Death: an adverse reaction to a drug is the suspected cause of death Life-Threatening Condition: a serious … [Read more...]
Xeljanz, Rinvoq, and Olumiant Safety Review by European Drug Regulator EMA
The JAK inhibitors drug class safety issue has landed in Europe, as indicated by this European Medicines Agency (EMA) February 11, 2022, news item, “EMA starts safety review of Janus kinase inhibitors for inflammatory disorders”. This Xeljanz, Rinvoq, and Olumiant safety review by the EMA follows a December 2021 JAK inhibitors drug class safety FDA … [Read more...]
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