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

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Lack of Warnings in Current Ocaliva Drug Label for Some Serious Side Effects Involving Liver, Gallbladder, Bile Ducts   (Posted by Tom Lamb at DrugInjuryWatch.com)   We are still wondering how the current FDA investigation of an Ocaliva safety signal — said to be involving a potential liver disorder risk — was able to fly below the radar for five months before first being reported in early October 2020. Remarkably, the first mention of…
October 2020 News Report Reveals “New” Ocaliva Liver Safety Issue, Which Had Been Under the Radar Previously   (Posted by Tom Lamb at DrugInjuryWatch.com)   Ocaliva (obeticholic acid) was approved by the FDA in 2016 for the treatment of a rare chronic liver disease, primary biliary cholangitis (PBC). Specifically, Ocaliva is FDA-approved for use in combination with ursodeoxycholic acid (UDCA) in adult PBC patients with an inadequate response to UDCA, or as monotherapy in…
New Beovu Warnings for Endophthalmitis and Retinal Detachment as well as Retinal Vasculitis, Retinal Vascular Occlusion   (Posted by Tom Lamb at DrugInjuryWatch.com)   In June 2020 Novartis revised the Prescribing Information for Beovu to add new warnings about some vision-related side effects linked to Beovu. In this earlier article, “Beovu Label Change: Warnings About Possible Permanent Vision-Loss Side Effects Added In June 2020“, about that Beovu label change we focused on…
Numerous Case Reports of Occlusive Retinal Vasculitis and Vision Loss in Patients Following Beovu Injections   (Posted by Tom Lamb at DrugInjuryWatch.com)   As early as May 2020 it was suggested by the authors of an Editorial piece published online by the American Journal of Ophthalmology that the use of Beovu injections should be suspended until the underlying cause of Beovu-associated inflammation is discovered. But the sale and use of Beovu continues to date…
Recent Bevou Label Change in Europe Adds Information About Retinal Vasculitis and Retinal Vascular Occlusion   (Posted by Tom Lamb at DrugInjuryWatch.com)   In mid-September 2020 Novartis announced the results of a Phase 3 head-to-head study comparing its relatively new eye medicine Beovu to Eylea, a more well-established competing eye drug product from Regeneron. According to Novartis, this study shows that after one year of treatment Beovu matched Eylea in terms of the best-corrected…
Belviq Safety Data Review Found Higher Rates of Colorectal Cancer, Pancreatic Cancer, and Lung Cancer   (Posted by Tom Lamb at DrugInjuryWatch.com)   The FDA’s decision to request that the pharmaceutical company Eisai recall its oral weight-loss drugs Belviq and Belviq XR (lorcaserin) earlier this year has been more fully explained in a new medical journal article written by FDA staff. This FDA Belviq recall decision came after a careful analysis of Belviq postmarketing…
Patients Consider Whether Relief from Bladder Pain is Worth Possibility of Elmiron-Associated Maculopathy and Other Eye Problems   (Posted by Tom Lamb at DrugInjuryWatch.com)   Approved by the FDA way back in 1996, Elmiron (pentosan polysulfate sodium / “PPS”) is prescribed for treatment of interstitial cystitis (“IC”), also known as “bladder pain syndrome” or “painful bladder syndrome”. However, in the past few years, there are case reports of Elmiron causing eye problems such as…
Medical Studies Find Elmiron “significantly increased odds of having atypical maculopathy” Such as Pigmentary Maculopathy   (Posted by Tom Lamb at DrugInjuryWatch.com)   Elmiron (pentosan polysulfate sodium) was approved by the FDA in 1996 for the treatment of interstitial cystitis (“IC”), also known as “bladder pain syndrome” or “painful bladder syndrome.”. In recent years, however, there have been reports of current as well as past Elmiron users developing vision loss due to Elmiron-related maculopathy.…
New Warnings Added To Drug Labels For All VEGF Inhibitors By UK’s MHRA Already; FDA Is Evaluating Need For Regulatory Action   (Posted by Tom Lamb at DrugInjuryWatch.com)   On July 31, 2020 the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued this Drug Safety Update, “Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection“, which began as follows: Before initiating systemic vascular endothelial growth factor (VEGF) pathway…
Woman Developed Acute And Severe Loss Of Visual Acuity Following Her Second Beovu Injection   (Posted by Tom Lamb at DrugInjuryWatch.com)   Beovu (brolucizumab) was approved by the FDA in 2019 for the treatment of neovascular (wet) age-related macular degeneration (AMD).  Since then there have been reports of Beovu-associated vision loss and blindness due to occlusive retinal vasculitis, retinal artery occlusion, and intraocular inflammation.  For example, we point out a Beovu retinal vasculitis case…