Here is the most recent information from the US Centers for Disease Control and Prevention (CDC) about the EzriCare and Delsam products recall for case reports associated with bacterial contamination: As of March 1, 2023, CDC, in partnership with state and local health departments, identified 64 patients in 13 states (CA, CO, CT, FL, IL, NJ, NM, … [Read more...]
EzriCare and Delsam Pharma’s Eye Drops Products Recall
In early February 2023 there was an artificial tears lubricant eye drops products recall involving EzriCare and Delsam Pharma’s Artificial Tears. As a standard practice, when a drug company announces a recall, market withdrawal, or safety alert, the FDA posts the company’s announcement as a public service. Here is the Global Pharma Healthcare … [Read more...]
EzriCare Artificial Tears Eye Infections Warnings
There is detailed information about the in this Centers for Disease Control and Prevention (CDC) Outbreak and Patient Notifications article, “Outbreak of Extensively Drug-resistant Pseudomonas aeruginosa Associated with Artificial Tears”, including this fact: As of January 31, 2023, CDC, in partnership with state and local health departments, … [Read more...]
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 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...]
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...]
Beovu Drug Label Revised December 2021 Was Issued in Europe, But Not in the US
A “new” Beovu drug label which was revised in December 2021 sets forth some additional information about the vision-related Beovu side effects intraocular inflammation, retinal vasculitis, and retinal vascular occlusion. We point out, however, that there was no similar 2021 Beovu label change issued by Novartis in the US. From this Drug Safety … [Read more...]
Elmiron-associated Retinopathy and Other Elmiron Eye Problem Side Effects
For some important details about Elmiron-associated retinopathy and other Elmiron eye problem side effects, we point out this excerpt from the Discussion part of this recent Clinical Ophthalmology medical journal article, ” “Pentosan Polysulfate Sodium-Associated Pigmentary Retinopathy: Risk Factors and Fundus Findings”, which was published on … [Read more...]
Beovu: Rates of Intraocular Inflammation and Retinal Vascular Occlusion
A November 2021 article published by the medical journal JAMA Ophthalmology, “Safety Outcomes of Brolucizumab in Neovascular Age-Related Macular Degeneration”, provides new information about the incidence rates of intraocular inflammation and retinal vascular occlusion associated with Beovu (brolucizumab). This is our 19th article about Beovu … [Read more...]