Drug Injury Watch

Elmiron Drug Safety-related Labeling Changes for Pigmentary Maculopathy Side Effect

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 following:

Changes in the retina of the eye (pigmentary maculopathy). Taking ELMIRON may be associated with pigment changes in the retina of the eye that may continue even after stopping treatment with ELMIRON. Tell your healthcare provider including your eye doctor right away if you have any vision changes including any of these symptoms:

• difficulty reading
• your vision takes longer to adjust to low
  or reduced light
• blurred vision

Throughout your treatment, regular eye examinations that include retinal examinations are suggested for early detection of retinal/macular changes....

This Elmiron Medication Guide mandated by the FDA Center for Drug Evaluation and Research (CDER) follows and reiterates the June 2020 Elmiron label change that added a new Warnings subsection, Retinal Pigmentary Changes, which starts with the following information:

Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON® (see ADVERSE REACTIONS). Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears to be a risk factor....

As background, before the June 2020 Elmiron label change adding this new warning about the pigmentary maculopathy Elmiron side effect, the Elmiron drug label had stated "Warnings: None".

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In February 2021 we posted an article, "Past Elmiron Use Linked to Pigmentary Maculopathy and Vision Loss, Again, by Two Recent Medical Studies", in which we reported:

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 a diagnosis of pigmentary maculopathy or macular degeneration.

As we have stated previously, the June 2020 Elmiron label change that finally added warnings concerning vision problems such as retinal pigmentary changes and pigmentary maculopathy was overdue from our perspective. Accordingly, there have been Elmiron lawsuits filed by patients who have suffered vision loss against the pharmaceutical companies responsible for Elmiron.

We are currently investigating possible Elmiron lawsuits for patients with past Elmiron use diagnosed with eye problems such as:

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

If we can be of assistance to you or someone you know with Elmiron-related eye damage, you can send an email to Tom Lamb or you can call us on our toll-free number: 800-426-9535. Or, if you prefer, simply submit an online Elmiron Case Evaluation Form -- it is free, confidential, and there is no obligation.

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)

Beovu Vision Loss Lawsuits Involve Serious Eye Problems due to Beovu Injections Reactions

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 are filed as individual cases and that there will not be any Beovu class actions for people who have experienced Beovu eye problems. Due to this situation, if a patient has vision loss or blindness after getting Beovu injections in their eyes, this person must contact a lawyer or law firm to handle their Beovu case in order to get legal compensation for the Beovu drug injury they have suffered.

Here are a few reasons why a person with a possible Beovu vision loss lawsuit might want to contact our law firm about handling their Beovu case for legal compensation.

First, we started investigating these Beovu eye problems soon after the American Society of Retinal Specialists (ASRS) issued a Beovu drug safety alert to its members in February 2020.  Therein the ASRS reported 14 cases of retinal vasculitis among patients who had Beovu injections administered in the several months after Beovu first became available in October 2019.

In fact, our February 27, 2020 article, "Beovu Side Effects Include Retinal Vasculitis, Eye Inflammation: Safety Issues For Macular Degeneration Drug", was one of the first articles written about these Beovu eye problems.

Second, during the past 13 months -- from February 2020 to March 2021 -- we have closely monitored this Beovu drug safety issue and written many more articles about the circumstances surrounding various Beovu eye injection reactions causing vision loss and blindness such as:

• Retinal Vasculitis
• Occlusive Retinal Vasculitis
• Retinal Artery Occlusion
• Retinal Vascular Occlusion

To learn more about these serious eye problems following Beovu injections you can look at the Beovu Side Effects page and the Beovu Timeline page over at our DrugInjuryLaw.com website.

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Third, the first three Beovu vision loss lawsuits filed in the US are for clients of our law firm. Each of those three women had their Beovu lawsuit filed as an individual case, which is indicated by this information for those Beovu lawsuits:

1. Harris v. Novartis Pharmaceuticals Corporation, et al.
2. Cohen v. Novartis Pharmaceuticals Corporation, et al.
3. Sundell v. Novartis Pharmaceuticals Corporation, et al.

The basic liability allegations in those Beovu lawsuits, as well as other Beovu cases concerning Beovu eye problems, are:

• Novartis misrepresented that Beovu was a safe treatment for age-related macular degeneration; and,
• Novartis failed to warn about Beovu eye injection reactions causing vision loss and blindness.

If we can be of assistance to you or someone else regarding a possible Beovu lawsuit for vision loss or blindness due to Beovu eye injection reactions, you can send an email to Tom Lamb or you can call us on our toll-free number: 800-426-9535.

Again, we point out these Beovu vision loss lawsuits are filed as individual cases and that there will be no Beovu class actions for Beovu eye problems. As such, people with Beovu eye injection reactions must contact a lawyer or law firm to have an individual Beovu lawsuit filed so they can get legal compensation from Novartis for their Beovu drug injury.

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)

Past Elmiron Use Linked to Pigmentary Maculopathy and Vision Loss, Again, by Two Recent Medical Studies

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 a diagnosis of pigmentary maculopathy or macular degeneration.

Elmiron (pentosan polysulfate sodium, or PPS) was approved by the FDA way back in September 1996 for the treatment of painful bladder syndrome (interstitial cystitis). In recent years, however, cases of Elmiron-related eye damage have been reported.

It is important to know that a patient does not have to have been using Elmiron regularly right up until the time when their pigmentary maculopathy or macular degeneration was diagnosed in order for those conditions to be considered Elmiron-related eye damage.

The first article, "Pentosan Polysulfate and Vision: Findings from an International Survey of Exposed Individuals", was published in December 2020 by the Retina medical journal. From the Abstract for this article:

• Purpose: To investigate patient-reported visual function in individuals taking [Elmiron (pentosan polysulfate sodium, or PPS)] for interstitial cystitis.
• Results: ... Respondents in the highest [Elmiron (pentosan polysulfate sodium, or PPS)] exposure tertile were more likely to report difficulty with reading small print (adjusted OR 2.29, 95%CI 1.15-4.57) and to have a diagnosis of macular degeneration and/or pigmentary maculopathy (adjusted OR 2.41, 95%CI 1.44-4.03) than unexposed respondents.

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The second article, "Maculopathy Secondary to Pentosan Polysulfate Use: A Single-Center Experience", was published in February 2021 by the Clinical Ophthalmology medical journal. From the Abstract for this article:

• Aim: To investigate the prevalence of retinal pathology in patients with a history of exposure to [Elmiron (pentosan polysulfate sodium, or PPS)].
• Methods: Patients exposed to [Elmiron (pentosan polysulfate sodium, or PPS)] and seen in the ophthalmology clinic at Northwestern University during 1/1/2002 to 1/1/2019 were identified from electronic health records (EHR) by an electronic data warehouse (EDW) search. Visual acuity (VA), reasons for clinic visit, ocular conditions, and duration of exposure to [Elmiron (pentosan polysulfate sodium, or PPS)] were noted....
• Results: A total of 131 patients who were exposed to [Elmiron (pentosan polysulfate sodium, or PPS)] and seen at the Northwestern Ophthalmology clinic were identified in the EHR. Forty patients of 131 had imaging. Patients with imaging or fundus examination suspicious for [Elmiron (pentosan polysulfate sodium, or PPS)] maculopathy were placed into the suspect group. Of the 40 patients that had imaging, 5 (12.5%) had features suspicious for PPS maculopathy. Of the remaining 91, 5 (5.4%) had macular pigmentary changes described on fundus exam. Among the 10 patients in the suspect group, the average duration of [Elmiron (pentosan polysulfate sodium, or PPS)] use was 4.2 years... and the average cumulative dose was 380g....

We are currently investigating possible Elmiron lawsuits for patients with past Elmiron use diagnosed with eye problems such as:

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

If we can be of assistance to you or someone you know with Elmiron-related eye damage, you can send an email to Tom Lamb or you can call us on our toll-free number: 800-426-9535. Or, if you prefer, simply submit an online Elmiron Case Evaluation Form -- it is free, confidential, and there is no obligation.

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)

Beovu Side Effects Have Caused Eye Doctors to Avoid Beovu and Use Other Safer AMD Drugs Instead

In Addition, the Three New Beovu Lawsuits Filed for Patients with Vision Loss May Further Impact Novartis Market Share

 

(Posted by Tom Lamb at Drug Injury Watch)

 

Since being approved by the FDA in 2019, Beovu (brolucizumab) has been associated with vision loss and blindness due to occlusive retinal vasculitis, retinal artery occlusion, and intraocular inflammation. In turn, during 2020 these Beovu side effects caused some eye doctors to avoid using Beovu injections for treatment of neovascular (wet) age-related macular degeneration (AMD). Now, at the start of 2021, Beovu lawsuits have been filed against Novartis, the manufacturer of Beovu, alleging this drug company failed to adequately warn doctors and patients about serious Beovu side effects.

We start with a "snap-shot" of where things stood a month ago for Beovu, before the three recently filed Beovu drug injury lawsuits. From this December 15, 2020 news article, "Beovu's success in Kestrel is unlikely to fly in the real world", by reporter Lisa Urquhart for Evaluate Vantage, we get the following:

Novartis is now two for two with its pivotal trials of Beovu in diabetic macular oedema, following positive results from the Kestrel study. In the 571-patient trial a 6mg dose of the single-chain antibody fragment was non-inferior to 2mg of Regeneron/Bayer's Eylea in terms of baseline changes in best corrected visual acuity. The trial confirms the results seen in the Kite study, and also showed that Beovu could be used with a three-month dosing schedule. However, Novartis’s success here is unlikely to turn the tide on Beovu’s disappointing launch. The product, which is marketed for wet age-related macular degeneration, has been beset by serious safety concerns including severe intraocular inflammation and sight-threatening occlusive retinal vasculitis that has seen not only a revision to its label, but several class action lawsuits. Beovu’s side-effects have caused physicians to avoid the drug for safer options and sales forecasts to crash. Any chances of Novartis capturing market share are also likely to be further impacted by the patent expiry of Lucentis, expected next year, while the market is also bracing for Eylea biosimilars in 2024.

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A possible indication of the Novartis strategy for battling back from this less-than-ideal current posture can be found in a "Novartis Fourth Quarter and Full Year 2020 Condensed financial report – Supplementary Data" document:

Post marketing cases termed as “intraocular inflammation.” and/or “retinal vascular occlusion” that may result in severe vision loss, typically associated with intraocular inflammation and the current COVID-19 situation had an unfavorable impact on sales. Novartis has a comprehensive plan, in strong collaboration with leading external global experts to educate the retina community about the positive benefit / risk profile of Beovu.   [See p. 12 of the 70-page PDF.]

We presume this Novartis plan to resurrect Beovu and get it back on its intended path of being a so-called "blockbuster" drug for Novartis in terms of sales involves its external safety review committee (SRC). In the past, Novartis has implied that this panel of experts was set up to provide an independent review of the Beovu side effects case reports. We reported on the most recent Novartis SRC findings made available to the public in this November 17, 2020 article, "Novartis Update on Patients Suffering from Retinal Vasculitis and/or Retinal Vascular Occlusion After Beovu Injections".

But one wonders what effect new Beovu lawsuits filed on behalf of individual patients who suffered severe loss of vision after receiving Beovu injections will have on eye doctors and AMD patients, alike. The first three of those Beovu lawsuits against Novartis (of which we are aware, at least) were filed during the past couple of weeks, with more to follow.

Given the serious nature and number of Beovu side effects reported to date, together with the Beovu lawsuits filed against Novartis for patients with vision loss, it seems fair to say that things look a bit grim for Beovu and Novartis at the present time.

Our law firm is investigating possible Beovu lawsuits for patients who have suffered vision loss or blindness due to Beovu side effects. If we can be of assistance to you or someone else regarding a Beovu drug injury case, you can send an email to Tom Lamb or you can call us on our toll-free number: 800-426-9535.

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)

 

 

Elmiron Maculopathy Secondary to Pentosan Polysulfate (PPS) Toxicity: Medical Journal Article

New Elmiron Study Suggests Established Maculopathy Patients Should be Asked About Possible Elmiron Use

 

(Posted by Tom Lamb at Drug Injury Watch)

 

Elmiron maculopathy secondary to pentosan polysulfate (PPS) toxicity was first reported in this 2018 Ophthalmology medical journal article, "Pigmentary Maculopathy Associated with Chronic Exposure to Pentosan Polysulfate Sodium".  Now a new Elmiron medical study about cases of macular toxicity related to PPS exposure suggests that established maculopathy patients should be questioned regarding any Elmiron use in the past.

This new study was a retrospective case series of four patients with pigmentary maculopathy, and its findings are presented in this article, "New Insights Into Pentosan Polysulfate Maculopathy", posted on January 21, 2021, by the medical journal Ophthalmic Surgery, Lasers and Imaging Retina, or OSLI Retina.

From that January 2021 medical journal article about Elmiron maculopathy we get this background information set forth in its Introduction section:

Macular toxicity secondary to pentosan polysulfate sodium (PPS) (Elmiron; Janssen Pharmaceuticals, Beerse, Belgium) was first reported in 2018. PPS is the only U.S. Food and Drug Administration (FDA)-approved oral treatment for interstitial cystitis (IC), a painful urological condition affecting approximately 45 in 100,000 women and eight in 100,000 men globally. Pearce et al. initially described six patients with PPS exposure (approximately 400 mg/day, average of 15 years) presenting with pigmentary maculopathies characterized by paracentral hyperpigmentation and nodular excrescences on optical coherence tomography (OCT) at the level of the retinal pigment epithelium (RPE) with negative genetic testing.

Subsequent articles investigated the strength of the association, described the phenotypic range of presentation, and generated screening recommendations. Diagnostic criteria described include: 1) bilateral pathology centered on the fovea, 2) paracentral macular hyperpigmented spots, 3) dense array of hyper- and hypoautofluorescent spots and reticular fundus autofluorescence (FAF) abnormalities, and 4) foci of nodular RPE enlargement on OCT corresponding to hyperreflectance on near-infrared reflectance imaging. Humphrey visual fields (HVF) ranged from normal to dense paracentral to central scotomas correlating with the degree of atrophy and analysis of electroretinography (ERG) revealed normal to diffusely dampened amplitudes. [Footnotes omitted.]

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Next, we look at the so-called "value-added" aspect of this new Elmiron medical study about cases of macular toxicity related to PPS exposure. From the Discussion section of the January 2021 OSLI Retina article:

This study provides novel information about the phenotype of PPS maculopathy. We demonstrate progression of FAF changes over 4 to 5 years (despite PPS discontinuation in one patient), collapse of nodular RPE excrescences over time, and quantification of drastic total retinal thinning in two patients during a 4- to 5-year follow-up period. We further showed FAZ abnormalities and choriocapillaris dropout on OCTA, and functional quantification of the previously reported subjective DA symptoms.

The strength of this analysis is the length of follow-up with incidental multimodal imaging over 4 years. FAF findings demonstrate increasing intensity and area of characteristic changes, and OCT data show progressive macular thinning. The choroidal thickness during the same period remained stable, whether that implies a degree of direct retinal toxicity remains to be elucidated....

Another contribution of this new Elmiron medical study to the medical literature has to do, in large part, with how one might diagnose Elmiron maculopathy secondary to pentosan polysulfate (PPS) toxicity. From the Conclusions section of the January 2021 OSLI Retina article:

Patients with long-term [use of Elmiron, i.e., exposure to PPS] may present with various pre-existing diagnoses but most PPS toxicity cases manifest with a specific constellation of OCT, FAF, and [OCT angiography (OCTA)] findings. Established maculopathy patients should be questioned regarding exposure to PPS, especially with negative genetic testing or atypical presentations. For patients with [cystoid macular edema (CME)], [carbonic anhydrase inhibitors (CAIs)] can be effective and may need to be continued long after the [Elmiron (PPS)] has been withdrawn. Patients can have progressive RPE changes even after [Elmiron] medication discontinuation, and vascular changes may imply mechanisms of toxicity involving both the choriocapillaris and RPE. The finding of significant choriocapillaris dropout may inform understanding of the pathophysiology.

Our law firm is investigating possible Elmiron lawsuits for patients who have suffered vision loss due to Elmiron maculopathy. If we can be of assistance to you or someone else regarding an Elmiron vision loss case, you can send an email to Tom Lamb or you can call us on our toll-free number: 800-426-9535.

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

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Elmiron Lawsuits Federal Court MDL is Created in December 2020, Assigned to Judge Martinotti

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 was assigned to U.S. District Judge Brian Martinotti, who oversee these Elmiron lawsuits which allege that Elmiron -- a pill used to treat chronic bladder infection called interstitial cystitis -- can cause Elmiron-related eye problems that can lead to vision loss or blindness.

In this September 2020 article, "Elmiron-Related Eye Problems Are Causing Patients to File Elmiron Lawsuits Against Pharmaceutical Companies", we explained the factual basis for the Elmiron lawsuits which will be included in this new Elmiron MDL:

Elmiron (pentosan polysulfate sodium / "PPS") 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 patients who used Elmiron developing vision loss due to Elmiron-related maculopathy. But there were not any warnings about these Elmiron eye problems in the Elmiron Prescribing Information document, or drug label, until June 2020, when the FDA mandated an Elmiron label change. This situation has resulted in Elmiron lawsuits filed by patients who have vision loss due to Elmiron.

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From the Transfer Order issued for In Re: Elmiron [Pentosan Polysulfate Sodium] Products Liability Litigation, MDL Docket No. 2973, we get the following legal information:

Plaintiffs in the District of New Jersey Dobbins action move under 28 U.S.C. § 1407 to centralize this litigation involving retinal injuries associated with the use of Elmiron (pentosan polysulfate sodium)....

No responding party opposes centralization....

After considering the argument of counsel, we find that centralization of these actions in the District of New Jersey will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation. The actions involve common factual issues concerning the propensity of Elmiron to cause retinal injuries, notably atypical or pigmentary maculopathy. Several defendants have marketed Elmiron since its approval in 1996. This litigation likely will implicate complex scientific and regulatory issues. Centralization will eliminate duplicative discovery; avoid inconsistent pretrial rulings; and conserve the resources of the parties, their counsel and the judiciary. [Footnote omitted.]

We are currently investigating possible Elmiron lawsuits for patients diagnosed with Elmiron-related eye problems such as:

• wither pigmentation maculopathy
• pigmentation macular degeneration
• pigmentation maculitis
• retinal maculopathy
• dry macular degeneration

We point out that a person does not need to have been using Elmiron at the time when their eye damage or retinal injury was diagnosed by a doctor in order to be in a position to file an Elmiron lawsuit.

If we can be of assistance to you or someone else regarding a possible Elmiron lawsuit, you can send an email to Tom Lamb or you can call us on our toll-free number: 800-426-9535.

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)

How Beovu Went from Potential Blockbuster AMD Drug for Novartis to Possible Beovu Drug Recall in 2021

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 the October 2019 launch of Beovu here in the US, Novartis was hoping its new age-related macular degeneration (AMD) drug would compete with Eylea and Lucentis, which were more established AMD drugs. But then came the unwanted Beovu adverse drug reactions and Beovu-related eye problems, with numerous reports of Beovu causing vision loss and blindness due to occlusive retinal vasculitis, retinal artery occlusion, and intraocular inflammation.

In this article, we walk you through the key events for Beovu in 2019 and 2020 that seem to have moved Beovu away from being a blockbuster AMD drug for Novartis and toward the possibility of there being a Beovu drug recall in 2021.

To start, Beovu was approved by the FDA on October 7, 2019, for the treatment of wet age-related macular degeneration (AMD).

From the outset, this launch of Beovu in the US was a bit rocky for Novartis, as seen by this excerpt from an October 8, 2019, Fierce Pharma piece, "Novartis takes on Regeneron, Roche blockbusters with Beovu approval":

The drug won approval for 8- and 12-week dosing intervals after a three-month loading phase of monthly injections. But SVB Leerink analysts pointed out that the label carries “higher safety liabilities” than Eylea. In the phase 3 trials, patients on Beovu were four times as likely to have intraocular inflammation than those on Eylea, at 4% and 1%, respectively.

Then on February 23, 2020, the American Society of Retinal Specialists (ASRS) issued a note to members about 14 cases of retinal vasculitis across 46,000 injections since Beovu’s launch, as reported by this news report, "Novartis' hot new eye drug Beovu tied to potential vision loss: experts".

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Battling back, a week later Novartis stated the current prescribing information document for Beovu sufficiently addresses its risks of intraocular inflammation and retinal artery occlusion. You can read more about that position in this March 2, 2020, article, "Novartis stands behind Beovu's safety, benefits after vision-loss warning".

About a month later, however, we saw this April 6, 2020,  BioPharmaDive item, "Eye drug side effects are real, Novartis confirms in new warning", reporting Novartis said it would work with the FDA, the European Medicines Agency (EMA), and other drug safety regulators around the world to issue a revised Beovu drug label with new warnings about Beovu-related eye problems.

Next, as announced in this June 9, 2020 Supplemental Approval letter, the FDA approved a label update for Beovu whereby Novartis will add warnings and safety information about retinal vasculitis and retinal vascular occlusion, which can lead to vision loss and blindness.

This was followed a few months later by the September 14, 2020, Novartis Media Release item, "European Medicines Agency (EMA) approves safety label update for Novartis Beovu®".

And lastly, there is this November 14, 2020 Reuters news report, "Novartis identifies possible risk factors for Beovu patients".  Summarily it let us know that, according to a safety review issued by Novartis, the main risk of experiencing Beovu adverse drug reactions such as retinal vasculitis and/or retinal vascular occlusion within the six months after the first administration of Beovu was prior intraocular inflammation and/or vascular occlusion in the year prior to the first injection of Beovu.

We will watch for further developments concerning these various Beovu adverse drug reactions and Beovu-related eye problems, as well as indications of a possible Beovu drug recall in 2021.

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)

Elmiron Pigmentary Maculopathy Risk Warning Issued by Janssen and Health Canada in December 2020

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 of Elmiron; and, (2) Elmirion is now contraindicated in patients with a previous history of any macular pathology.

As background, pigmentary maculopathy is an eye disease that changes the center of the retina (also called the "macula"). In turn, pigmentary maculopathy may harm the patient’s vision and may lead to a permanent decrease or loss of central vision.

From the December 2020 Elmiron "Dear Doctor" letter we get the following details:

Cases of pigmentary maculopathy have been reported with long-term use of ELMIRON. Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears to be a risk factor. Visual symptoms in the reported cases included difficulty reading, slow adjustment to low or reduced light environments, and blurred vision.

This recent Elmiron "Dear Doctor" letter sent out in Canada also provides some guidance to patients who have used Elmiron:

Patients should report to their healthcare professional any changes in their vision such as difficulty reading, slow adjustment to low or reduced light, blurred vision, blurry or wavy vision near or in the centre of their field of vision.

For more about the symptoms of pigmentary maculopathy as well as how doctors might diagnose this serious eye disease which may lead to significant vision loss, we refer you to a December 22, 2020 medical article, "From Bladder Pain to Blurry Vision: Pentosan Polysulfate Sodium and the Development of a Novel Maculopathy", published in Ophthalmic Surgery, Lasers and Imaging Retina.

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From that article we get the following medical information about Elmiron pigmentary maculopathy:

Symptoms most commonly reported were blurred vision, prolonged dark adaptation, and metamorphopsia. The most common presenting diagnoses for these cases were macular or pattern dystrophy and age-related macular degeneration. [Visual acuity (VA)] correlated with degree of foveal atrophy, and in some cases, cystoid macular edema (CME) or choroidal neovascularization. There is one case of CME that was responsive to anti-vascular endothelial growth factor (VEGF) therapy.

Clinical features of [Elmiron (pentosan polysulfate sodium)] maculopathy are quite distinct from other macular dystrophies or toxicity. These include 1) bilateral symmetric pathology centered on and frequently involving the fovea, 2) macular hyperpigmented spots, yellow-orange deposits, and/or patchy RPE atrophy, with 3) densely packed hyper- and hypoautofluorescent spots on FAF, and 4) focal [retinal pigment epithelium (RPE)] thickening on [optical coherence tomography (OCT)] with hyperreflectance on [near-infrared reflectance (NIR)] imaging. In particular, a peripapillary hypoautofluorescent halo can be useful in distinguishing [Elmiron (pentosan polysulfate sodium)] maculopathy from [age-related macular degeneration (ARMD)] and hereditary dystrophies that are usually peripapillary-sparing.... [Footnotes omitted.]

This December 2020 medical journal article contains a couple of alerting statements:

• The prevalence of maculopathy in patients taking [Elmiron (pentosan polysulfate sodium)] is estimated to be 20% to 25%. In a cohort of 219 patients with [interstitial cystitis (IC)], patients with [Elmiron (pentosan polysulfate sodium)] exposure had an odds ratio (OR) of 11.25 for developing an unspecified pigmentary maculopathy, and all 14 patients with definite clinical characteristics of [Elmiron (pentosan polysulfate sodium)] maculopathy had exposure to [Elmiron (pentosan polysulfate sodium)]. [Footnotes omitted.]
• In aggregate, these findings are potentially alarming and possibly represent a major patient safety issue. Many patients with PPS exposure may have been previously misdiagnosed with age-related macular degeneration or retinal dystrophies, which may have led to preventable, irreversible vision loss or misguided genetic counseling.

Our law firm is investigating possible Elmiron lawsuits for patients who have suffered vision loss due to Elmiron pigmentary maculopathy. If we can be of assistance to you or someone else regarding an Elmiron vision loss case, you can send an email to Tom Lamb or you can call us on our toll-free number: 800-426-9535.

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Case Report: Retinal Vasculitis and Vitritis After Three Beovu Injections Followed by a Later Lucentis Treatment

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 -- in accordance with the current guidance from a therapeutics committee of the American Society of Retina Specialists (ASRS) investigating the drug safety issue of Beovu vision loss -- her doctors administered a Lucentis treatment. Soon thereafter this patient developed severe vitritis with worsening occlusive retinal vasculitis.

That patient's doctors are the authors of this recent medical journal article, "Brolucizumab-related retinal vasculitis with exacerbation following ranibizumab retreatment: A clinicopathologic case study", which presents the interesting case report. We use this excerpt from the Abstract for this recent medical journal article to provide an overview of the situation:

A 76-year old Caucasian woman experienced pain, decreased vision and floaters one week after receiving her third monthly intravitreal [Beovu (brolucizumab)] injection in the right eye for exudative age-related macular degeneration. Examination was significant for 0.5+ anterior chamber cells, vitritis, mild peripheral vascular sheathing, and decreased vision from 20/70 to 20/200. She was started on topical 1% prednisolone acetate with improvement in her examination. She was switched to [Lucentis (ranibizumab)] one month after her last [Beovu (brolucizumab)] injection of the right eye. Three weeks after her [Lucentis (ranibizumab)] injection, she noticed photophobia, pain and decreased vision. Examination revealed worsening uveitis, vitritis, vascular sheathing, and decreased vision to count fingers.

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For a look at what might have happened after the three injections of Beovu resulting in retinal vasculitis and intraocular inflammation, we get the following from the Discussion part of that case report article:

The ASRS [Research and Safety in Therapeutics (ReST)] committee report stated that 56% of patients developed an occlusive retinal vasculitis after the 2nd or 3rd [Beovu (brolucizumab)] injection. In eyes treated with [Beovu (brolucizumab)], retinal vasculitis can be delayed as long as 8 weeks after an injection, with an average time of 25.5 days from the most recent [Beovu (brolucizumab)] injection....

In our patient, after the 3rd injection of [Beovu (brolucizumab)] there was a mild episode of inflammation and retinal sheathing; presumably, the initial exposure was from the previous [Beovu (brolucizumab)] injections. After injecting [Lucentis (ranibizumab)], retinal occlusive vasculitis, worsening intraocular inflammation and severe vision loss occurred. The rationale for using [Lucentis (ranibizumab)] was that previous reports from the ASRS ReST committee already documented cases after rechallenge with [Eylea (aflibercept)] without worsening inflammation, and recommended re-treatment with anti-VEGF agents after inflammation resolved. In this patient, apparent vascular inflammation had subsided at the time of re-treatment and she had also previously responded more favorably to [Lucentis (ranibizumab)]. One possibility is that during an inflammatory event when an immune response is directed to proteins such as [Beovu (brolucizumab)], the body upregulates its immunogenicity to other similar proteins with decreased specificity. Since both [Beovu (brolucizumab)] and [Lucentis (ranibizumab)] are humanized antibody sequences produced in Escherichia coli, [Lucentis (ranibizumab)] may have some cross-reactivity and antigenic similarity to [Beovu (brolucizumab)], thus becoming a target through an already primed immune system. Another possibility is that the adverse effects of the [Beovu (brolucizumab)] hypersensitivity was delayed and its full effects were only seen coincidentally after injecting [Lucentis (ranibizumab)].   [footnotes omitted]

The bottom line appears to be this woman's doctors are uncertain whether (1) Lucentis had a role in the retinal occlusive vasculitis, worsening intraocular inflammation, and severe vision loss she suffered soon after her Lucentis injection, or (2) this was a case of Beovu vision loss due to delayed Beovu hypersensitivity.

However, in the Abstract we find this statement at the "Conclusion and importance" part:

Treatment with [Beovu (brolucizumab)] can result in intraocular inflammation and retinal vasculitis likely due to a delayed hypersensitivity reaction to the drug, supported by cytopathologic analysis of a vitreous sample. We demonstrate a case where retreatment with an alternative anti-VEGF agent resulted in worsening vision and vasculitis.

Our law firm is investigating possible Beovu lawsuits for patients who have suffered vision loss or blindness due to Beovu-related retinal vasculitis or other Beovu side effects. If we can be of assistance to you or someone else regarding a Beovu vision loss case, you can send an email to Tom Lamb or you can call us on our toll-free number: 800-426-9535.

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)

Beovu Vision Loss Cases - A Medical Update: What is Known, Unknown, and Still Emerging as of December 2020

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 question is whether it is worth taking the very small risk of intraocular inflammation [following a Beovu injection] that could potentially cause irreversible vision loss when we have three well-established, effective agents that don’t carry this potential risk,” Holekamp said....

According to Holekamp, the 4.6% rate of inflammatory reactions seen in the trials, which was higher than the rate seen in contemporary trials for currently available Lucentis (ranibizumab, Genentech) and aflibercept, was likely a safety signal that may have been overlooked by the FDA approval process [for Beovu].

“And it turned out to be a significant one, as after [Beovu] was launched, we started seeing cases of severe, irreversible vision loss,” she said.

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Here are two recent medical journal articles that address (1) the ongoing investigation to find the root cause of these Beovu vision loss cases, and (2) the search for the best medical management or treatment methods for Beovu patients with occlusive retinal vasculitis resulting in vision loss:

• "Risk of inflammation, retinal vasculitis and retinal occlusion-related events with brolucizumab: post-hoc review of HAWK and HARRIER", published November 15, 2020, by the medical journal Ophthalmology.
• "Expert Opinion on Management of Intraocular Inflammation, Retinal Vasculitis, and/or Vascular Occlusion after Brolucizumab Treatment", published September 28, 2020, by the medical journal Ophthalmology Retina.

Starting back in February 2020, we have been investigating possible Beovu lawsuits for patients who have suffered vision loss or blindness due to Beovu-related retinal vasculitis or other Beovu side effects. If we can be of assistance to you or someone else regarding a Beovu vision loss case, you can send an email to Tom Lamb or you can call us on our toll-free number: 800-426-9535.

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)