Drug Injury Watch

Elmiron-associated Retinopathy Risks Increased by (1) Longer Duration Use and (2) Higher Cumulative Dosage

Elmiron Lawsuits Filed Because Drug Company Failed to Warn Before June 2020 About Elmiron-related Vision Loss Side Effects

 

(Posted by Tom Lamb at Drug Injury Watch)

 

We are handling Elmiron lawsuits for patients who have developed Elmiron-associated retinopathy, retinal pigmentary changes, or pigmentary maculopathy due to their past use of Elmiron. These Elmiron lawsuits are filed against the drug companies responsible for Elmiron. This is because — despite a growing number of Elmiron-related vision loss case reports in the medical literature over the years — it was not until June 2020 that any warning about these eye problem side effects was included in the Elmiron drug label here in the US.

Both before and after that Elmiron label change in June 2020, there have been various medical studies about the association between Elmiron and serious eye problems such as retinal pigmentary changes or pigmentary maculopathy. We have written several earlier Drug Injury Watch posts, starting back in 2020, covering some of the medical journal articles reporting on those Elmiron side effects studies.

In this post, we draw your attention to the latest such Elmiron study report article, "Pentosan Polysulfate Sodium-Associated Pigmentary Retinopathy: Risk Factors and Fundus Findings", which was published just days ago (December 24, 2021) by the Clinical Ophthalmology medical journal.

From the Abstract we get a summary of this December 2021 medical journal article about Elmiron:

• Purpose: To evaluate the risk factors and fundus findings of patients with potential [Pentosan Polysulfate Sodium / Elmiron]-associated retinopathy.
• Patients and Methods: A retrospective chart review was performed of patients exposed to [Pentosan Polysulfate Sodium / Elmiron] who had a dilated fundus examination at a large retina-only practice from 2018– 21. Multimodal images were evaluated by masked reviewers.
• Results: A total of 148 patients were included, of whom 33 (22%) had [Pentosan Polysulfate Sodium / Elmiron]-associated retinopathy, and 115 (78%) did not. The mean age was 60.3 years old, and the mean follow-up was 11.8 months. The [Pentosan Polysulfate Sodium / Elmiron]-associated retinopathy group had higher mean cumulative doses of [Pentosan Polysulfate Sodium / Elmiron] (1600g± 849 vs 864g± 852, P < 0.0001, Mann–Whitney test) and longer duration of [Pentosan Polysulfate Sodium / Elmiron] use (13.6 years vs 7.48, P < 0.0001). There was no statistically significant difference based on a history of kidney or liver disease or the dosage per day for the weight, body mass index, body surface area, or lean body weight. Of the patients with [Pentosan Polysulfate Sodium / Elmiron]-associated retinopathy whose genetic results were available, 15 of 16 (93%) were heterozygous for variants of uncertain significance.
• Conclusion: A longer duration of [Pentosan Polysulfate Sodium / Elmiron] use and higher cumulative dosage of [Pentosan Polysulfate Sodium / Elmiron] were associated with an increased risk of developing [Pentosan Polysulfate Sodium / Elmiron]-associated pigmentary retinopathy. The role of genetic mutations in patients exposed to [Pentosan Polysulfate Sodium / Elmiron] is still to be determined.

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For some important details about Elmiron-associated retinopathy, we point out this excerpt from the Discussion part of that Clinical Ophthalmology medical journal

Some patients with [Pentosan Polysulfate Sodium / Elmiron]-associated retinopathy may unfortunately experience difficulty with dark adaptation, reading, contrast sensitivity, and changes in mesopic microperimetry. In the current study, the [Pentosan Polysulfate Sodium / Elmiron]-associated retinopathy group was more likely to have complaints of difficulty with their visual field, reading, dark adaptation, and visual acuity....

There is currently no treatment for [Pentosan Polysulfate Sodium / Elmiron]-associated maculopathy, and the retinopathy can progress even after discontinuing [Pentosan Polysulfate Sodium / Elmiron]. In a multicenter study of 11 patients who had discontinued [Pentosan Polysulfate Sodium / Elmiron], 77% continued to experience progression, with the RPE atrophy growing at a rate of 0.32mm per year, and 9% developing worsening vision over 12 months.... [footnotes omitted]

We are currently investigating possible Elmiron lawsuits for patients diagnosed with Elmiron-associated retinopathy as well as these other serious Elmiron side effects:

• Maculopathy (retinal or pigmentation)
• Retinal Pigmentary Endothelium Injury (RPE)
• Pigmentation Maculitis
• Macular Degeneration (pigmentation or dry)
• Vision Loss / Blindness

It is important to know that our Elmiron lawsuits for patients who have suffered any of these Elmiron side effects are filed only against the pharmaceutical companies responsible for Elmiron — not the doctors who prescribed the Elmiron as a treatment for their bladder diseases.

Significantly, it is not necessary for the patient to have been using Elmiron regularly right up until the time when their Elmiron-related vision loss was diagnosed in order to file an Elmiron lawsuit. That is, unlike most other drug injury cases, the patient could have stopped using Elmiron months before a medical doctor was able to diagnose their eye problem.

For possible Elmiron lawsuits, we encourage you to submit an Elmiron Case Evaluation Form online – it is free, confidential, and there is no obligation. Or, if you prefer, call our toll-free number, (800) 426-9535, to speak directly to attorney Tom Lamb.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

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Beovu Safety Developments Presented by JAMA Ophthalmology Medical Journal in November 2021

Meanwhile, Still Waiting for the Anticipated Beovu Label Change That Was Previewed by Novartis Back in May 2021

 

(Posted by Tom Lamb at Drug Injury Watch)

 

As the year 2021 draws to an end, we point out some Beovu safety developments which were presented last month by the JAMA Ophthalmology medical journal. We have been tracking Beovu safety issues since February 2020, when we posted this article, "Beovu Side Effects Include Retinal Vasculitis, Eye Inflammation: Safety Issues For Macular Degeneration Drug".

We begin our latest article about Beovu safety issues with this Original Investigation item published November 24, 2021, by the medical journal JAMA Ophthalmology, "Safety Outcomes of Brolucizumab in Neovascular Age-Related Macular Degeneration".

From the Abstract for this November 2021 JAMA Ophthalmology article, we point out these selected parts:

• Importance:  Limited data exist on the real-world safety outcomes of patients with neovascular age-related macular degeneration treated with brolucizumab (Beovu).
• Objective:  To determine the real-world incidence of intraocular inflammation (IOI), including retinal vasculitis (RV) and/or retinal vascular occlusion (RO), for patients with neovascular age-related macular degeneration who underwent [Beovu (brolucizumab)] treatment. Additionally, potential risk factors associated with these adverse events were evaluated.
• Conclusions and Relevance:  The incidence rate of IOI and/or RO was approximately 2.4%. Patient eyes with IOI and/or RO in the 12 months prior to first [Beovu (brolucizumab)] injection had the highest observed risk rate for IOI and/or RO in the early months after the first [Beovu (brolucizumab)] treatment. However, given study limitations, the identified risk factors cannot be used as predictors of IOI and/or RO events, and causality with [Beovu (brolucizumab)] cannot be assessed.

The full text of that JAMA Ophthalmology medical journal article ends as follows:

In conclusion, data from the IRIS Registry and Komodo Healthcare Map provided insights into the safety of patients with neovascular AMD who initiated [Beovu (brolucizumab)]. Patient eyes with IOI and/or RO in the 12 months prior to the first [Beovu (brolucizumab)] injection had the highest estimated incidence rate for an event of any form of IOI and/or RO in the 6 months after first [Beovu (brolucizumab)] treatment. Similar findings were observed among patients with RV and/or RO events. Additional studies with longer follow-up intervals are needed to assess the long-term safety of [Beovu (brolucizumab)] treatment. These results represent early findings that explore potential risk factors for inflammation-associated AEs that may occur following real-world treatment with [Beovu (brolucizumab)]. However, because of study limitations, the identified risk factors cannot be used as predictors of IOI and/or RO events and the causality with [Beovu (brolucizumab)] cannot be assessed.

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Next, there is an Invited Commentary piece related to the above medical journal article which was also published November 24, 2021, by the medical journal JAMA Ophthalmology titled "Risk Factors for Intraocular Inflammation After Brolucizumab Treatment", written by Caroline R. Baumal, MD, of the New England Eye Center, at Tufts Medical Center.

Dr. Baumal's JAMA Ophthalmology piece concludes with this statement:

Looking to the future, there are recently completed and ongoing studies evaluating [Beovu (brolucizumab)] (ClinicalTrials.gov, term brolucizumab) to treat retinal disorders that can be combined to provide further information on the incidence, safety, risk factors, and treatment strategies. The patient should be educated about the potential safety issues, therapeutic options, and symptoms of IOI. Clinicians should maintain heightened awareness for RO and/or RV with IOI after [Beovu (brolucizumab)] and be familiar with diagnostic imaging protocols especially widefield fluorescein angiography and recommended treatment algorithms. Based on the current literature, same-day bilateral [Beovu (brolucizumab)] injections should be avoided and [Beovu (brolucizumab)] is contraindicated in eyes with active IOI or a history of IOI related to [Beovu (brolucizumab)]. Based on the study from Khanani and colleagues, a recent history of IOI and/or RO should be considered as another potential risk factor for [Beovu (brolucizumab)]-related IOI.

We will continue to watch for Beovu safety developments which are presented in medical journals or addressed in medical news reports, as well as an anticipated Beovu label change previewed by Novartis back in May 2021 (see: "Beovu Vision Loss Side Effects Continue to Plague Novartis, Ending 3 Key Clinical Trials in May 2021").

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

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December 2021 JAK Inhibitors Drug Class Label Changes: More Warnings and Use Restrictions

Risks of Cancers, Blood Clots, Heart Problems, and Deaths Associated with Xeljanz, Olumiant, and Rinvoq

 

(Posted by Tom Lamb at Drug Injury Watch)

 

As background, in September 2021 the FDA announced that it was requiring revisions to the "Black-Box" warnings already on the drug labels for Xeljanz, Olumiant, and Rinvoq "to include more information about the risks of serious heart-related events, cancer, blood clots, and death." (See: "FDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions")

Before going into some commentary found in news reports about the effects of this December 2021 JAK inhibitors drug class safety development, here are links to the "new" drug label for Xeljanz, Olumiant, and Rinvoq:

• Current Prescribing Information for Xeljanz (Revised: 12/2021)
• Current Prescribing Information for Olumiant (Revised: 12/2021)
• Current Prescribing Information for Rinvoq (Revised: 12/2021)

Xeljanz is a Pfizer drug, Rinvoq is an AbbVie drug, and Olumiant is an Eli Lilly drug. As we wrote about in this recent article, "Eli Lilly Attempts to Distance Olumiant From the Ominous JAK Inhibitors Drug Class Safety Issues Flagged by FDA", the pharmaceutical companies AbbieVie and Eli Lilly have attempted to distinguish the safety profile of their respective JAK inhibitors drug product from the various adverse drug reactions that have been observed in the Xeljanz clinical trial that have driven the FDA regulatory actions driving these December drug label changes.

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One pharmaceutical industry commentator thinks that AbbVie may have an advantage in "market share" going forward as regards the three JAK inhibitors drugs approved for the treatment of rheumatoid arthritis, given some details of the new drug label for Rinvoq. From this December 6, 2021, Fierce Pharma news report, "AbbVie's Rinvoq, Pfizer's Xeljanz and Lilly's Olumiant slapped with new FDA warnings amid JAK safety crackdown", we get the following:

Rinvoq appears to have got what [SVB Leerink analyst Geoffrey Porges] called “milder language” on the risks. The new Rinvoq boxed warning specifies that the higher rates of the safety problems over TNF blockers are observed in another JAK inhibitor. What’s more, there were no restrictions on how long a patient can take Rinvoq.

The somewhat better-than-expected wording will “make a modest difference” only to new physicians or those who aren’t familiar with JAKs, he said in a Monday note.

Nevertheless, Porges believes Rinvoq is in a better position than the other two JAK inhibitors “given the strength of the data and AbbVie’s well-entrenched position in immunology.” Plus, no other drug regulators outside the U.S. have posted similar restrictions, he noted.

For a similar viewpoint, we move to this December 6, 2021, Evaluate Vantage piece, "New label warnings raise hopes for Jak safety closure", which also indicates that this December 2021 JAK inhibitors drug class FDA regulatory action could have been worse:

The full fallout from the FDA’s safety review of the Jak inhibitors remains unknown, amid concerns about moves to curb these drugs’ use drastically. But two label updates that emerged late Friday are raising hopes that draconian measures are off the table. Abbvie and Pfizer announced new boxed warnings for their respective products, Rinvoq and Xeljanz. These black boxes now highlight the higher rate of major adverse cardiac events seen versus anti-TNF agents in the Oral Surveillance trial of Xeljanz. As expected, both have also had rheumatoid arthritis indications scaled back, with patients required to have failed at least one TNF blocker. Analysts believe that Abbvie has come off as well as could be expected, with the label wording making it clear that the [major adverse cardiovascular events (MACE)] signal was seen with “another Jak inhibitor”, and no restrictions on duration of use; some were expecting harsher action from the regulator.

We will continue to monitor the pharmaceutical regulatory sector as well as the medical literature for future developments as regards the increased risks of cancers, blood clots, heart problems, and deaths associated with Xeljanz, Olumiant, and Rinvoq.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)