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Increased Risk for This New Vision/Eyes Side Effect Highest in Elderly Patients and Chronic Kidney Disease Patients   (Posted by Tom Lamb at Drug Injury Watch)   In June 2021 it was reported that Invokana, Farxiga, and Jardiance, as well as other drugs in the Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors class, are associated with an increased risk of retinal vein occlusion. This new SGLT2 inhibitors side effect was the subject of a presentation at the…
Outside Experts Could Review All JAK Inhibitors Risk/Benefit Profiles as Regards Several Requested New Indications   (Posted by Tom Lamb at Drug Injury Watch)   A few months ago we wrote about a possible FDA Advisory Committee meeting for Xeljanz, Rinvoq, and other Janus kinase (JAK) inhibitors in this April 15, 2021 post, “Xeljanz and Other JAK Inhibitors: Drug Safety Concerns Indicated by Recent FDA Actions“. And recently the FDA delayed its…
For Patients with Polyester-based Polyurethane (PE-PUR) Exposures, Potential Health Risks Include Cancers and Organ Failures   (Posted by Tom Lamb at Drug Injury Watch)   In June 2021, the healthcare technology company Royal Philips issued a products recall for certain Philips Bi-Level PAP, CPAP, and Mechanical Ventilator devices due to possible toxic exposures from the polyester-based polyurethane (PE-PUR) sound abatement foam component in these Philips products.  From our perspective,  a few cancers and some…
New Jersey Tasigna Multi-county Litigation (MCL), Federal Court Tasigna Multidistrict Litigation (MDL)   (Posted by Tom Lamb at Drug Injury Watch)   In early June 2021, the New Jersey Supreme Court consolidated Tasigna drug injury lawsuits filed against Novartis Pharmaceuticals Corp. before one judge for pretrial proceedings as part of a New Jersey state court multi-county litigation (MCL). And in July 2021 the U.S. Judicial Panel on Multidistrict Litigation (JPML) is expected to hear…
And Novartis “has yet to identify the root cause behind Beovu’s safety problem”, According to a News Report   (Posted by Tom Lamb at Drug Injury Watch)   Starting back in February 2020, when the American Society of Retinal Specialists (ASRS) issued a note to members about 14 cases of retinal vasculitis, Beovu vision loss side effects have handed Novartis setbacks in its efforts to capture market share from Eylea. And in late May…
May 2021 FDA Drug Safety Communication: Ocaliva Label Change: Prescribing Information Will be Adding and Updating Warnings    (Posted by Tom Lamb at Drug Injury Watch)   Ocaliva (obeticholic acid) was listed on the “April – June 2020 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)” report for “Liver disorder”, and the status as of June 12, 2020, was “FDA is evaluating the…
We Take a 2021 Look at the Findings on Increased Risk of Elmiron-associated Pigmentary Maculopathy   (Posted by Tom Lamb at Drug Injury Watch)   At the 2021 Southeastern Educational Congress of Optometry (SECO) meeting in Atlanta GA, Nate Lighthizer, OD, FAAO, stated what is rather well known by now, that long-term use of Elmiron, a drug used to treat interstitial cystitis, has been linked to pigmentary maculopathy. During his SECO presentation about the…
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…