Law Offices of Thomas J. Lamb, P.A.

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Legal Cases Involve Elmiron Causing Eye Damage and Retinal Injury Such as Atypical or Pigmentary Maculopathy   (Posted by Tom Lamb at Drug Injury Watch)   On December 15, 2020, the Judicial Panel on Multidistrict Litigation (JPMDL) granted a plaintiffs’ motion to centralize all currently filed federal court lawsuits involving the bladder drug Elmiron and assigned that multidistrict litigation (MDL) to the U.S. District Court for the District of New Jersey. This Elmiron MDL …
Key Events for Beovu 2019 – 2020: FDA Approval, Safety Alerts and Warnings, Drug Label Changes, Novartis Investigation   (Posted by Tom Lamb at Drug Injury Watch)   Leading up to launch of Beovu in October 2019, Novartis was hoping its new age-related macular degeneration (AMD) drug would compete with Avastin, Eylea, and Lucentis, which were more established AMD drugs here in the US. But then came the unwanted Beovu adverse drug reactions and…
New Medical Article Describes How to Identify, Image, and Diagnose Pigmentary Maculopathy Caused by Elmiron Use   (Posted by Tom Lamb at Drug Injury Watch)   On December 15, 2020 a Dear Healthcare Professional Letter titled, “ELMIRON (pentosan polysulfate sodium) and the Risk of Pigmentary Maculopathy“, was issued in Canada by Janssen, Inc. and Health Canada.  Its key messages were: (1) Cases of Elmiron pigmentary maculopathy have been reported with long-term use…
Woman Had Severe Vision Loss with Retinal Occlusive Vasculitis, Worsening Intraocular Inflammation; Due to Beovu, Lucentis, or Both?   (Posted by Tom Lamb at Drug Injury Watch)   In the December 2020 edition of American Journal of Ophthalmology Case Reports, there is a “unique scenario” where a 76-year-old woman was treated with three injections of Beovu resulting in retinal vasculitis and intraocular inflammation one week after the Beovu third injection. About one month later…
Potentially Life-Changing Beovu Side Effects, Root Cause Remains Uncertain, Medical Management Methods Being Developed   (Posted by Tom Lamb at DrugInjuryWatch.com)   From a December 1, 2020 Ocular Surgery News article, “Retina specialists receptive but cautious regarding use of Beovu“, we get this snapshot view of the still-developing safety issue of significant vision loss following Beovu injections: “[Beovu (brolucizumab)] is, at this stage, a risk-benefit question,” Nancy M. Holekamp, MD, said…. “The…
November 2020 Report: Beovu Eye Side Effects Risks Higher for Beovu Patients with Prior Intraocular Inflammation and/or Vascular Occlusion   (Posted by Tom Lamb at DrugInjuryWatch.com)   We have known since early 2020 that Beovu treatments may be associated with intraocular inflammation, with or without retinal vasculitis, which can lead to Beovu patients developing vision loss. In mid-November 2020 Novartis announced the initial findings of a “coalition” established by Novartis to examine the root…
European Medicines Agency (EMA) and Novartis Issue Dear Doctor Letter About Gilenya Label Change   (Posted by Tom Lamb at DrugInjuryWatch.com)   A recent periodic review of Gilenya safety data by the European Medicines Agency (EMA) has turned up cases of Gilenya-related liver failure and drug-induced liver injury associated with Gilenya.  That new Gilenya safety information was presented in this EMA periodic safety update report, “Gilenya (fingolimod): Updated recommendations to minimise the risk
Beovu Legal Cases Involve Retinal Artery Occlusion, Retinal Vasculitis, Intraocular Inflammation, Other Eye Problems   (Posted by Tom Lamb at DrugInjuryWatch.com)   Beovu (brolucizumab) is prescribed for the treatment of neovascular (wet) age-related macular degeneration (AMD). Since being approved by the FDA in late 2019, Beovu has been associated with vision loss and blindness due to occlusive retinal vasculitis, retinal artery occlusion, intraocular inflammation, and other serious eye problems. In turn, it is likely…
A Global Phase-out of Picato Sales by LEO Pharma Inc. Due to this Picato Safety Finding Expected by End of 2020   (Posted by Tom Lamb at DrugInjuryWatch.com)   On October 27, 2020 Health Canada announced a Picato recall due to a the Picato safety finding “that there may be a link between PICATO and an increased risk of non-melanoma skin cancer”, as explained in this document: “PICATO (ingenol mebutate gel, 0.015% and
Stelara-Associated Acute Coronary Syndrome, Stroke, and Unstable Angina Seen in Recent Stelara French Medical Study   (Posted by Tom Lamb at DrugInjuryWatch.com)   Stelara (ustekinumab) was approved by the FDA in 2009, initially for Crohn’s Disease and Psoriatic Arthritis, then Ulcerative Colitis in October 2019 and Psoriasis in July 2020. Now, despite these recent additional treatment indications, there is an emerging drug safety issue for Stelara. In particular, Stelara-associated cardiovascular events were reported in…