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responsible for the lymphoma medicine Ukoniq (umbralisib), TG Therapeutics, indicated in April 2022 that Ukoniq was withdrawn from the market due to an increased risk of death in patients using Ukoniq.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...]
Health Canada Breast Implant Safety Review Shows High Risk of BIA-ALCL with Textured Implants
A recent Health Canada safety advisory comes following an updated safety review of breast implants and the associated risk of BIA-ALCL. According to the April 6, 2022 Health Canada advisory "Advisory - Updated safety review of breast implants underscores the continuing importance of monitoring for cancer; increased risk with highly textured … [Read more...]
Abemaciclib for Previously Treated Patients With p16ink4A-Deficient Mesothelioma
As reported in The Lancet Oncology by Dean A. Fennell, FRCP, and colleagues, a phase II trial (MiST2) showed the activity of [ Verzenio (abemaciclib) ] in previously treated patients with p16ink4A-deficient malignant mesothelioma. As stated by the investigators, “Genetically stratified therapy for malignant mesothelioma is unavailable. … [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...]
EPA rule would finally ban asbestos, carcinogen still in use
The Environmental Protection Agency [(EPA)] on Tuesday proposed a rule to finally ban asbestos, a carcinogen that is still used in some chlorine bleach, brake pads and other products and kills thousands of Americans every year. The proposal marks a major expansion of [ Environmental Protection Agency (EPA) ] regulation under a landmark 2016 law … [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...]
Early Clinical Activity With CDK4/6 Inhibitor in Pretreated Mesothelioma
[ Verzenio (abemaciclib), a drug that has proven effective in breast cancer, ] showed preliminary activity in its first-ever clinical trial in mesothelioma. The cyclin-dependent kinase (CDK) 4/6 inhibitor [ Verzenio (abemaciclib) ] achieved disease control at 12 weeks in 14 of 26 patients with progressive mesothelioma associated with a CDKN2A … [Read more...]
Biphasic Peritoneal Mesothelioma: A Lethal Clinical Entity
Abstract: Mesotheliomas are a rare malignancy of the serosal membrane. Mainly it affects the pleural surfaces followed by the second most common location, “peritoneum.” The disease follows an aggressive pattern of spread, and by the time the diagnosis is established, the condition significantly spreads to distant locations. Diagnosis of malignant … [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...]
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