We continue to monitor the medical literature for developments relevant to the important drug safety issue of drug-induced liver injury (DILI). This medical journal article, "ACG Clinical Guideline: Diagnosis and Management of Idiosyncratic Drug-Induced Liver Injury", appeared in The American … More
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Recent News & Case Reports
Ocrevus PML Case Report: Patient Used Ocrevus, Only, Without Prior Tysabri or Gilenya Use
The primary source for this Ocrevus PML case report is a JAMA Neurology Brief Report item dated March 16, 2021, "Progressive Multifocal Leukoencephalopathy in a Patient With Progressive Multiple Sclerosis Treated With Ocrelizumab Monotherapy". From the Abstract for that medical journal article we … More
Possible FDA Advisory Committee Meeting for Xeljanz, Olumiant, and Rinvoq in Future
Based on these several recent developments, we expect that there will be an FDA Advisory Committee Meeting for Xeljanz, Olumiant, and Rinvoq in the months to come. The focus of such will likely be these adverse drug events and side effects related to the JAK inhibitors class of drugs: Heart … More
There Will Be No Belviq Generic Drugs After Belviq Drug Recall in 2020
There has been some further FDA action regarding Belviq which is related to the 2020 Belviq drug recall that was due to an increased risk of cancer. This further FDA action means there will be no Belviq generic drugs after the Belviq drug recall in 2020. This February 26, 2021 Notice item, … More
Are Heart Problems and Cancers JAK Inhibitors Drug Class Safety Issues?
Since the February 2021 FDA alert about Xeljanz-associated heart problems and possible Xeljanz-related cancers was issued, we have been watching for any related drug safety developments concerning Olumiant and Rinvoq. The reason being there has been some concern that those adverse drug events and … 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 … More