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...]
Elmiron and Maculopathy: Two Recent Medical Articles About an Elmiron Vision Side Effect
In this post, we look at some relatively recent research regarding the still-emerging drug safety issue of Elmiron and maculopathy, i.e., maculopathy is an Elmiron vision side effect. According to “Screening needed for pentosan polysulfate sodium-associated maculopathy”, published on September 2, 2021, by Ocular Surgery News: In most cases, … [Read more...]
Novartis Stops 3 Beovu Clinical Trials in May 2021, Wants a Beovu Label Change
In late May 2021, the latest study data concerning Beovu safety issues resulted in Novartis stopping three key clinical trials — MERLIN, RAPTOR, and RAVEN — as well as Novartis indicating there will be another Beovu label change. To see how Novartis is seeking to present the current status of its lingering Beovu safety issues as well as the next … [Read more...]
New Elmiron Medication Guide Points Out Retinal Pigmentary Eye Problems
The new Elmiron Medication Guide mandated by the FDA Center for Drug Evaluation and Research (CDER) in March 2021 follows and reiterates the June 2020 Elmiron label change that added warning about the pigmentary maculopathy Elmiron side effect. We point out that before the June 2020 Elmiron label change adding this new warning about the … [Read more...]
Beovu Lawsuits Lawyer / Law Firm Handles Individuals’ Cases, Not Beovu Class Actions
We want to clear up some possible confusion. If a patient has vision loss or blindness after getting Beovu injections in their eyes, this person must contact a lawyer or law firm to handle their Beovu case in order to get legal compensation for the Beovu drug injury they have suffered. That is because Beovu lawsuits are being filed as individual … [Read more...]
Elmiron Can Double the Risk of Pigmentary Maculopathy or Macular Degeneration
Elmiron (pentosan polysulfate sodium, or PPS) was approved by the FDA way back in September 1996 for the treatment of painful bladder syndrome (interstitial cystitis). Over the past several years, however, cases of Elmiron-related eye damage have been reported. Remarkably, according to a recent medical study, patients with high levels of Elmiron … [Read more...]