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American College of Gastroenterology Requested a Group of Experts to Develop New Guidelines for DILI   (Posted by Tom Lamb at Drug Injury Watch)   This medical journal article, “ACG Clinical Guideline: Diagnosis and Management of Idiosyncratic Drug-Induced Liver Injury“, appeared in The American Journal of Gastroenterology (AJC) May 2021 edition. From the Abstract for this article, we get this overview: Idiosyncratic drug-induced liver injury (DILI) is common in gastroenterology and hepatology…
Compare 9 Earlier Cases of PML in MS Patients After Ocrevus Treatments: Those Involved Earlier Tysabri and/or Gilenya Use   (Posted by Tom Lamb at Drug Injury Watch)   Pharmaceutical company Genentech knew about the first monotherapy Ocrevus PML case no later than October 2019, but important details about the subject patient and its ramifications in terms of Ocrevus drug safety just came to light in March 2021. The reasons for this delay in…
Possible FDA Advisory Committee Meeting for Xeljanz, Olumiant, and Rinvoq Mentioned by Commentators   (Posted by Tom Lamb at Drug Injury Watch)   Drug safety observers are watching the effects a recent FDA alert about Xeljanz-associated heart problems and possible Xeljanz-related cancers has had on other Janus kinase (JAK) inhibitors in the past few weeks.  And this has caused some to mention a possible FDA Advisory Committee Meeting for Xeljanz, Olumiant, and Rinvoq, which…
Belviq Was Withdrawn From Market Due to Increased Risk of Certain Cancers: Pancreatic, Colon, Rectal, And Lung   (Posted by Tom Lamb at Drug Injury Watch)   Recently we found some further FDA action regarding Belviq related to the 2020 Belviq recall which was due to an increased risk of cancer.  In the March 4, 2021 edition of the Federal Register, there was this February 26, 2021 Notice item, “Determination That BELVIQ (Lorcaserin
Do the JAK Inhibitors Rinvoq and Olumiant Also Have an Increased Risk of These Adverse Drug Events and Side Effects?   (Posted by Tom Lamb at Drug Injury Watch)   In February 2021 this FDA Drug Safety Communication, “Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)“‘ was released. Since then, it has been noted that this FDA…
March 2021: New Elmiron Medication Guide for Patients Points Out Retinal Pigmentary Eye Problems   (Posted by Tom Lamb at Drug Injury Watch)   By means of a March 12, 2021, Supplemental Approval letter for Elmiron (pentosan polysulfate sodium) capsules, the FDA announced that certain patient labeling information about Elmiron was being converted to a new Elmiron Medication Guide. In particular, as regards the pigmentary maculopathy Elmiron side effect, this Medication Guide includes the…
People Need to Know These Beovu Lawsuits are Individual Cases; No Beovu Class Actions for Beovu Eye Problems   (Posted by Tom Lamb at Drug Injury Watch)   Starting in January 2021 Beovu lawsuits have been filed for patients alleging Novartis failed to warn doctors and patients about Beovu eye injection reactions which can lead to severe vision loss and blindness. It is important for people to know that these Beovu vision loss lawsuits…
Patients with High Levels of Elmiron Use Have More Than a 2-Times Increased Risk of Developing Serious Eye Problems   (Posted by Tom Lamb at Drug Injury Watch)   Two new medical journal articles provide further support for the fact that past Elmiron use is associated with pigmentary maculopathy and vision loss. Remarkably, according to one medical study, patients with high levels of Elmiron use have more than a 2-times increased risk for getting…
February 2021 FDA Warning: Xeljanz Increased Risks for Serious Heart-related Problems and Cancers    (Posted by Tom Lamb at Drug Injury Watch)   During the past few years, there have been some Xeljanz drug safety alerts issued by the FDA based on a post-marketing safety clinical trial ordered by the FDA when it first approved Xeljanz (tofacitinib) in 2012. That clinical trial often goes by its short name, ORAL Surveillance, instead of its full…
Apparently, the Xeljanz Black Box Warning Added in July 2019 Was Not Enough; Is a Xeljanz Recall Coming Next?   (Posted by Tom Lamb at Drug Injury Watch)   In early February 2021 the FDA doubled-down on these two Xeljanz safety issues: (1) Xeljanz causing heart problems; and (2) Xeljanz causing cancer. This FDA Drug Safety Communication, “Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and