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 … More
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Recent News & Case Reports
New Xeljanz Warnings From FDA in 2021; Are Other JAK Inhibitors Next?
After the January 2021 release of limited data from a Xeljanz safety trial which often goes by its short name, ORAL Surveillance, some experts raised the possibility that there may consequences for other drugs in the Janus kinase (JAK) inhibitors class of drugs. Specifically, some have asked whether … More
Xeljanz 2021 FDA Warnings: Xeljanz Causing Heart Problems and Xeljanz Causing Cancer
The Xeljanz safety issues of Xeljanz causing heart problems and Xeljanz causing cancer were already "highlighted" by means of the Xeljanz Black Box Warning added back in 2019. But in February 2021 the FDA pointed out these Xeljanz side effects again in this FDA Drug Safety Communication, "Initial … More
Beovu Side Effects and Beovu Lawsuits for Patients Complicate Future for Beovu
Given the serious nature and number of Beovu side effects reported to date, together with the Beovu lawsuits filed against Novartis for patients with severe vision loss, it seems fair to say that things look a bit grim for Beovu and Novartis at the start of 2021. So what does the path forward look … More
Maculopathy Patients Should be Asked About Any Elmiron Use in Past
A new Elmiron medical study about cases of macular toxicity related to PPS exposure suggests that established maculopathy patients should be questioned regarding any Elmiron use in the past. This will help eye doctors determine whether this person may have Elmiron maculopathy secondary to pentosan … More
Gilenya Label Change with New Liver Injury Risk Warnings in Canada
In the final two months of 2020, we saw a Gilenya label change adding new liver risk warnings announced by drug regulators in Europe, first, and the United Kingdom (UK), later. Next, in January 2021, Health Canada posted a Gilenya drug safety alert about patients developing Gilenya-associated liver … More