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...]
Possible Ukoniq Drug Recall Due to Increased Risk of Death
Ukoniq (umbralisib) was approved by the FDA in February 2021 to treat adults with two types of lymphoma cancer that have returned or it did not respond to prior treatment: Marginal Zone Lymphoma (MZL); and, Follicular Lymphoma (FL). Only a year later, however, there is a new FDA Ukoniq safety investigation after a so-called “safety signal” … [Read more...]
Xeljanz Safety Study Final Findings Presented in January 2022
The Xeljanz safety study final findings from the so-called “ORAL Surveillance” trial ordered by the FDA were examined in this January 26, 2022 article, “Trial Data Confirm Heightened Risks With JAK Inhibitor”, by medical news reporter John Gever for MedPage Today. That January 2022 MedPage Today news report provides a “snapshot” of the current … [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...]
Xeljanz Safety Alert for People Who Are (1) Older, (2) Current / Past Smokers, or (3) With Cardiovascular or Cancer Risk Factors
This excerpt from the “Advisory – Health Canada safety review finds link between the use of Xeljanz and Xeljanz XR (tofacitinib) and increased risk of serious heart-related issues and cancer” issued in January 2022 provides an overview of the Xeljanz drug safety issue, and how the Xeljanz side effects risks may also apply to Olumiant and … [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...]
Cancers, Blood Clots, Heart Problems, and Deaths Associated with Xeljanz, Olumiant, and Rinvoq
We continue to monitor the pharmaceutical regulatory sector as well as the medical literature for developments as regards the increased risks of cancers, blood clots, heart problems, and deaths associated with Xeljanz, Olumiant, and Rinvoq. In December 2021 there was another JAK inhibitors drug class safety development, with Xeljanz, Olumiant, … [Read more...]
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