Drug Safety Developments

Voluntary Recall of Smoking Cessation Drug Chantix Issued by Pfizer

Voluntary Recall Comes Following Discovery of High Levels of N-Nitroso-Varenicline 

 

Written by: Lauren Schwab, Legal Assistant

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

 

Pfizer has expanded its September 16, 2021 voluntary recall of smoking cessation aid Chantix to include all lots of the 0.5mg and 1mg tablets. The recall comes following the discovery of high N-nitroso-varenicline levels above the acceptable limit set by the Food and Drug Administration (FDA).

Ingestion of N-nitroso-varenicline at high levels may be associated with a potential increased risk of cancer. In a September 16, 2021 company announcement issued by Pfizer, they stated:

Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication. The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.

Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.ⁱ

Chantix is a treatment to help patients quit smoking and is intended for short term use. People who smoke cigarettes are 15 to 30 times more likely to get lung cancer than people who do not smoke.

In a September 17, 2021 update issued by the FDA, the agency notified consumers that while the voluntary recall is still in place, the FDA will allow certain manufacturers to continue to distribute the drug under certain restrictions temporarily in order to avoid a drug shortage:

To lessen the impact to patients from a drug shortage due to this ongoing recall, FDA will not object to certain manufacturers distributing varenicline tablets containing N-nitroso-varenicline above FDA’s acceptable intake limit of 37 ng per day but below the interim acceptable intake limit of 185 ng per day until the impurity can be eliminated or reduced to acceptable levels.

The agency has temporarily exercised regulatory flexibility and discretion with respect to Apotex's distribution of Health Canada-approved Apo-Varenicline tablets in the U.S. containing N-nitroso-varenicline up to FDA’s interim acceptable intake limit in order to help maintain adequate varenicline supply in the U.S. for the near term.

FDA reminds patients taking recalled varenicline to continue taking their current medicine until their pharmacist provides a replacement or their doctor prescribes a different treatment. The health benefits of stopping smoking outweigh the cancer risk from the nitrosamine impurity in varenicline.

Pfizer claims to have notified their direct consignees by letter in order to arrange for the return of the recalled product. In the September 16, 2021 communication from the company, the following instructions were given for those who believe they may possess any of the recalled products:

As communicated by FDA, there is no immediate risk to patients taking Chantix. Patients who are taking this product should consult with their health care provider to determine if alternate treatments are available. Patients with Chantix Tablets should contact Stericycle Inc. at 888-276-6166 (Mon.-Fri. 8:00 am - 5:00 pm ET) for instructions on how to return their product and obtain reimbursement for their cost.

As always, we will continue to monitor voluntary and FDA mandated drug recalls and will provide you with any new or relevant information. Please feel free to share any relevant information with us, as well.

 

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FDA Sued Over Adverse Events Related to Hair Loss Drug Propecia

Popular Hair Loss Drug Associated with High Risk of Depression and Suicidal Ideation

 

Written by: Lauren Schwab, Legal Assistant

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

 

On September 8, 2021, Public Citizen filed a lawsuit against the Food and Drug Administration (FDA) regarding the popular hair loss drug, Propecia. The lawsuit was filed on behalf of the Post-Finasteride Syndrome Foundation (PFSF). Public Citizen and PFSF are asking the FDA to remove Propecia from the market, due to an increased risk of depression and suicide ideation associated with the drug.

Propecia prescriptions have significantly increased in the past few years. Four years ago, PFSF filed a citizen petition asking the FDA to revoke its approval of Propecia due to the adverse events being reported after use of the drug. Additionally, the PFSF asked the FDA to require the drug manufacturers to revise the safety information label to disclose the risk of side effects. The FDA has not yet responded to this original petition.

According to September 2021 article, "FDA Sued Over Inaction on Dangerous Hair Loss Medication Propecia", long term use of the drug can lead to several adverse side effects:

The risk of suicidal ideation associated with finasteride has been known for years. The VigiBase global database, which tracks adverse effects from global pharmacovigilance agencies, lists 378 cases of suicidal ideation, 39 cases of suicide attempt and 88 cases of suicide associated with finasteride use. Additionally, a 2020 study concluded that patients under age 45 who used finasteride for hair loss were vulnerable to depression, anxiety and suicidal ideation.

The drug also inhibits multiple steroid hormone pathways necessary to the formation of brain neurosteroids that regulate many critical functions in the central nervous system, like sexual function, mood, sleep, cognitive function, the stress response, and motivation.

In the same article, Dr. John Santmann, the head of PFSF, claims Propecia is doing more harm than good with its current label and FDA status:

“False information from the FDA leads physicians to dismiss patients, while some even tell them their symptoms are not real,” said John Santmann, M.D., the head of PFSF. “Without effective treatments for PFS, use of this cosmetic drug can lead to a lifetime of side effects. The drug ruins more lives every day and has no business being on the market.”

According to the VigiBase global database, which collects information regarding adverse reactions from global pharmacovigilance agencies, there have been 378 reports of suicidal ideation, 39 cases of suicide attempt and 88 cases of suicide associated with Propecia use. In addition to its adverse mental health effects, long term use of Propecia has been linked to post-finasteride syndrome (PFS). PFS can lead to sexual dysfunction and psycho-neurocognitive symptoms, even years after ending use of the drug.

As of September 10, 2021, the FDA has yet to comment on the initial petition filed by PFSF, nor the lawsuit filed on September 8, 2021. Be assured, however, that we will continue to follow the coverage of Propecia as well as watch for possible FDA regulatory action concerning Propecia.

 

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MiraLAX PEG 3350 Research Sees Minimal Progress

Few Advancements Have Been Made in Studies Aimed at Linking PEG 3350 and MiraLAX

 

Written by: Lauren Schwab, Legal Assistant

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

 

For the past few years, we have reported on the popular over-the-counter constipation drug MiraLAX, and its adverse side effects in children. While the Food and Drug Administration (FDA) continues to fund research for a potential connection between the two, few advancements have been made in the research.

 

MiraLAX and PEG 3350 Overview

Many pediatricians have recommended parents use MiraLAX to treat chronic childhood constipation in children under the age of 16.  However, the drug quickly became a topic of discussion amongst parents, as many parents report behavioral and neurological issues in their children that they claim stem from the child's use of MiraLAX.

Polyethylene glycol (PEG) 3350 is a class of medications, more easily known as "osmotic laxatives". The laxative works by retaining water within the stool to increase the number of bowel movements and softens the stool so it is easier to pass. Typically, PEG 3350 comes in a powder form, and is meant to be mixed with water and taken once a day as needed for up to two weeks, or up to one week for children under the age of 16, as directed by a doctor. 

 

Minimal Progress in PEG 3350 Study

As previously reported in our January 2021 article "Boston Children's Hospital Offers Alternatives to MiraLAX for Constipation Treatment", few advancements have been made in The Children's Hospital of Philadelphia (CHOP)'s FDA-funded PEG 3350 study in relation to MiraLAX and other over-the-counter constipation relief medications. 

According to CHOP's Research Institute page on the PEG 3350 Study (Accessed: 7/30/2021), patients have not yet been enrolled for the main clinical absorption study:

We have not begun enrolling children for the main clinical absorption study.  Once enrollment begins, an announcement will be made on the CHOP website. This study is not designed to evaluate children who may have experienced side effects of PEG 3350 in the past and we will not answer questions about use of PEG 3350 containing medicines until our study is complete. Parents should talk to their child’s pediatrician regarding use of products containing PEG 3350 if they have specific questions regarding their child.  

According to the website, the FDA has received reports from concerned parents that the component of PEG 3350 in MiraLAX may have caused neurobehavioral symptoms in their children. The CHOP study is aimed at determining is PEG 3350 is absorbed into the blood, but due to the difficulty in measuring the volatile PEG 3350 component, the study is still currently in its first phase.

 

Additional Information and Sources

While few advancements have been made in terms of PEG 3350 research in relation to MiraLAX use by children, parents and other family members may find comfort in joining the Facebook group "Parents Against MiraLAX".  Additionally, you may want to consider referring to our February 2020 article, "MiraLAX: The Quest to Get Answers from the FDA"  for more information of past PEG 3350 studies.

As always, we will continue to monitor the issues surrounding MiraLAX and will provide you with any new or relevant information. Please feel free to share any relevant information with us, as well.

Philips Brand Breathing Devices Part of June 2021 Product Recall

Potential Health Risks Including Cancers and Organ Failure Associated with Products

 

Written by: Lauren Schwab, Legal Assistant

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

 

Back in April 2021, Philips released a safety update regarding issues with an unidentified component in some of the Philips Sleep and Respiratory Care products portfolio.

Thereafter, on June 14, 2021, Philips issued a recall notification for specific Philips breathing devices that contained a sound abatement foam component used in certain of its Continuous Positive Airway Pressure (CPAP) devices, BiLevel Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators.

According to a June 2021 article, "Philips issues recall involving sleep and respiratory care devices", the majority of those Philips breathing devices covered by this recent Philips recall are in the first-generation DreamStation product family:

According to a news release, the majority of the affected devices within the advised five-year service life are in the first-generation DreamStation product family. The complaint rate registered at 0.03% in 2020, Philips said.

The Amsterdam-based company determined through testing that there are possible risks to users related to the PE-PUR sound abatement foam component, including the possibility of the foam degrading into particles that may enter the device’s air pathway and be ingested by the user.

Additionally, the foam may off-gas certain chemicals and its degradation may be exacerbated by unapproved cleaning methods, such as ozone. High heat and high humidity environments may also contribute to the foam’s degradation.

According to the Philips Communications Page about this Philips breathing devices recall, patients using life-sustaining mechanical ventilator devices should not stop or alter their prescribed therapy until after discussing other options with their physician. Additionally, the website states patients using Bi-Level PAP and CPAP devices can discontinue use and should work with their physician and Durable Medical Equipment provider to determine alternative options for treatment.

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The previously mentioned June 2021 article, "Philips issues recall involving sleep and respiratory care devices", says Philips currently has no reported deaths in association with the recall, and the company said it is working with the relevant regulatory authorities to remedy the issue:

“We deeply regret any concern and inconvenience that patients using the affected devices will experience because of the proactive measures we are announcing today to ensure patient safety,” Philips CEO Frans van Houten said in the news release. “In consultation with the relevant regulatory agencies and in close collaboration with our customers and partners, we are working hard towards a resolution, which includes the deployment of the updated instructions for use and a comprehensive repair and replacement program for the affected devices. Patient safety is at the heart of everything we do at Philips.”

As previously reported on LambLawOffice.com, due to potential toxic exposure from the sound abatement component used in these Philips products, the most serious possible resulting medical conditions for patients who used one of the recalled Philips Bi-Level PAP devices, Philips CPAP devices, or Philips Mechanical Ventilators are:

Cancers, such as:

— Lung Cancer
— Liver Cancer
— Kidney Cancer

Organ Failures, such as:

— Liver Failure
— Kidney Failure

We are investigating product liability lawsuits against Philips for patients with toxic exposures from the polyester-based polyurethane (PE-PUR) sound abatement foam component in the Philips products recalled in June 2021. These Philips breathing devices lawsuits could be personal injury cases or wrongful death cases, depending on the facts.

If you or someone you know used one of the recalled Philips Bi-Level PAP, Philips CPAP, or Philips Mechanical Ventilator devices and, in turn, developed cancer or experienced organ failure, we are providing free case evaluations for possible lawsuits against Philips. You can use our online Philips Breathing Devices Case Evaluation Form or, if you prefer, call us on our toll-free number, 800-426-9535.

 

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Xeljanz Under Safety Review for Health Canada

Xeljanz Linked to Increased Rick of Serious Heart-Related Issues and Cancer

 

Written by: Lauren Schwab, Legal Assistant

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

 

Xeljanz, a popular drug used to treat moderate to severe rheumatoid arthritis as well as moderate to severe ulcerative colitis, is under evaluation by Health Canada after results from a clinical trial showed links between the drug and serious heart-related issues and cancer.

This is not the first time Xeljanz has been under review by Health Canada, however. In 2019, Xeljanz was linked to an increased risk of blood clots in the lungs and potentially death following the publication of the results of a clinical trial. Health Canada and the drug manufacturing company, Pfizer, worked together to update both the Xeljanz and Xeljanz XR label to include thrombosis in the warnings section.

 

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According to the April 6, 2021 Canadian safety alert, Pfizer and Health Canada are once again working together to evaluate the safety of Xejanz and Xeljanz XR:

The clinical trial investigated the long-term safety of Xeljanz and Xeljanz XR (tofacitinib) at two doses (5 mg twice a day and 10 mg twice a day) in patients with rheumatoid arthritis, who are at least 50 years of age and have at least one cardiovascular risk factor. Pfizer, the manufacturer of the drug, conducted the trial in multiple countries, including Canada.

The current Canadian label includes serious warnings and precautions for cancer and information on heart attacks, which were the most frequently reported serious heart-related problems in this trial.

Health Canada has not authorized the sale of the higher dose of 10 mg twice a day for rheumatoid arthritis or psoriatic arthritis; this dose is only authorized for patients with ulcerative colitis who have not responded well to other medications. For patients with ulcerative colitis, the Canadian prescribing information recommends that they use the lowest effective dose possible to lower the risk of adverse reactions.

As previously mentioned on our February 2021 Drug Injury Watch blog article, "Xeljanz Has A New Drug Safety Issue, We Just Don't Know How Significant It Is, Yet", in the U.S., many experts are advocating for more research on the long-term effects of Xeljanz:

In our recent post, "Xeljanz FDA Drug Safety Communication in February 2021 Puts Heightened Scrutiny on Pfizer", we touched upon the two latest Xeljanz safety issues, Xeljanz causing heart problems and Xeljanz causing cancer. But there is still a lot that we do not know, yet, about how significant this new drug safety issue, or will be, for Xeljanz -- and Pfizer, the pharmaceutical company responsible for Xeljanz.

Be assured that we will continue to follow their coverage of Xeljanz as well as watch for possible FDA regulatory action concerning Xeljanz and Xeljanz XR.

 

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Avastin and Other VEGF Inhibitors Linked to Aneurysm and Artery Dissection

New Study Shows Further Evidence of Adverse Events in Association With VEGF Inhibitor Drugs

 

Written by: Lauren Schwab, Legal Assistant

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

 

A class of cancer treatment drugs labeled as antiangiogenic agents have been associated with artery dissections and aneurysms.  An arterial dissection occurs when there is a tear in the lining of an artery, which can cause blood to pool in the area, potentially leading to the formation of a blood clot.  An aneurysm is an enlargement of an artery caused by a weakening of the artery wall, and while most aneurysms do not show symptoms, if ruptured they can result in internal bleeding or a stroke.

According to the Medpage Today March 2021 article, "Class of Cancer Drug Linked to Aneurysms, Artery Dissections", which focused on the JAMA Oncology study "Association Between Antiangiogenic Drugs Used for Cancer Treatment and Artery Dissections or Aneurysms", this specific class of cancer drugs are 3 times more likely to result in an artery dissection or aneurysm than other cancer drugs:

The analysis of the WHO's VigiBase database found that artery dissections or aneurysms were nearly three times as likely to be reported with antiangiogenic agents as compared with other cancer drugs (proportional reporting ratio 2.76, 95% CI 2.48-3.07; Bayesian information component 1.14, 95% credibility interval 0.99-1.25), reported Pernelle Noize, PharmD, PhD, of Bordeaux University Hospital in France, and colleagues.

Among nearly 500 cases of artery dissections or aneurysms associated with these agents, 88.3% were serious, with 24.3% being fatal, 17.8% considered life-threatening, and 24.7% leading to or prolonging hospitalization, according to the findings in JAMA Oncology.

The same Medpage Today article lists several vascular endothelial growth factor (VEGF) inhibitors as being associated with artery dissections or aneurysms, including Avastin, Sutent, and Ofev:

Fourteen individual agents in the class were associated with artery dissections or aneurysms, including the VEGF inhibitors bevacizumab (Avastin) and ramucirumab (Cyramza); the tyrosine kinase inhibitors (TKIs) sunitinib (Sutent), pazopanib (Votrient), axitinib (Inlyta), nintedanib (Ofev), and lenvatinib (Lenvima); the multikinase inhibitor cabozantinib (Cometriq, Cabometyx); and the mTOR inhibitor everolimus (Afinitor). A number of these agents were also associated with both aortic- and cerebral-specific events.

VEGF inhibitors were the most commonly involved antiangiogenic agent (51.4%), followed by TKIs (35.8%) and mTOR inhibitors (11.5%). For individual agents, bevacizumab (44.9%), sunitinib (14.4%), and everolimus (11.1%) were most frequently associated with these events. Median time to onset was 89 days (interquartile range 27-212) where data were available.

 

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The data from this antiangiogenic drug study aligns with the July 2020 Drug Safety Update from the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) previously reported on our Drug Injury Watch Blog in August 2020, "Vascular Endothelial Growth Factor (VEGF) Inhibitors: Increased Risk Of Aneurysm And Artery Dissection".  The MHRA update required a warning label to be added to all VEGF inhibitors advising of the risks of aneurysm and artery dissection associated with this class of drugs.

This same class of drugs appeared on the January through March 2020 FDA watch list as having a potential signal of serious risk of aneurysm and artery dissection.  As of June 2020, the FDA was evaluating the need for regulatory action.  This class of drugs did not appear on the following three quarterly reports from the FDA, and whether or not regulatory action will be taken against these drugs is unclear at the present time.

We will continue to monitor the safety profiles for these VEGF inhibitors, including whether the FDA mandates any label changes which add warnings about an increased risk of aneurysm and artery dissection for this class of drugs.

 

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Talc Powder Associated With Health Risks Including Cancer

Talc Potentially Linked to Ovarian Cancer by Health Canada Report

 

Written by: Lauren Schwab, Legal Assistant

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

 

A recent Health Canada safety alert issued on April 22, 2021, addresses the health risks associated with talc exposure, specifically addressing the link between talc contamination and ovarian cancer.

Under the Chemicals Management Plan, Health Canada and Climate Change Canada conducted a joint screening assessment of talc, finding certain uses of talc may be harmful to human health. The inhalation of talc has been linked to several lung issues, and the usage of self-care products in the female genital area has been associated with ovarian cancer.

Talc can be found in certain health care products, such as cosmetics, non-prescription drugs, baby powder, deodorants, bath bombs and more. It is recommended to check the ingredients list on your product labels and avoid using products that contain talc.

According to this April 2021 Health Canada safety alert, the Canadian Government is proposing cautionary measures to help reduce talc exposure:

The Government of Canada is proposing measures to:

• help reduce exposures to talc from certain cosmetics which may be inhaled or which could come in contact with the female genital area, by modifying the existing entry on the Cosmetic Ingredient Hotlist; and
• help reduce exposures to talc from certain natural health products and non-prescription drugs, which may be inhaled or which could come in contact with the female genital area by modifying the existing entries of the Natural Health Products Ingredients Database and applicable monographs.

Canada is the first country in the world to propose action to help manage the human health risks of talc based on concerns related to ovarian cancer and lung effects for all age groups.

As we have previously reported on our Asbestos-Mesothelioma website, talc contaminated with asbestos can lead to mesothelioma.  In the US, the Food and Drug Administration (FDA) now has standards in place regarding testing of talc to determine whether asbestos is present.

Mesothelioma is caused by inhalation or ingestion of asbestos fibers, which then become embedded in the lining of either the lungs, abdomen, or heart.  This causes inflammation, and eventually, the formation of tumors in the affected areas.

There are several different types of mesothelioma:

• Pleural Mesothelioma (of the lungs)
• Peritoneal Mesothelioma (of the abdomen)
• Pericardial Mesothelioma (of the heart)

While there are factors that can increase someone’s risk of developing mesothelioma, only asbestos has been scientifically proven to cause the disease.

As always, we will continue to monitor the worldwide issues surrounding asbestos litigation involving talc-based beauty products and mesothelioma. We will provide you with any new or relevant information.

We encourage you to visit our Asbestos – Contaminated Talc and Mesothelioma Cancer Overview page on our website for more information. Please submit a free case evaluation if you or someone you know has been diagnosed with mesothelioma.

 

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Health Canada Issues Safety Review for Xeljanz in April 2021

Xeljanz May Be Linked to Serious Heart-Related Issues and Cancer

 

Written by: Lauren Schwab, Legal Assistant

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

 

Health Canada has issued a safety review of Xeljanz and Xeljanz XR -- relatively new drugs commonly used to treat rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis -- due to a clinical trial that showed an increased risk of serious heart-related issues and cancers when taking these drugs.

According to an April 2021 alert from Health Canada, "Health Canada has initiated a safety review on Xeljanz and Xeljanz XR (tofacitinib), used to treat arthritis and ulcerative colitis", Health Canada is working with Pfizer, the drug manufacturer, to inform the public about new drug safety findings:

The clinical trial investigated the long-term safety of Xeljanz and Xeljanz XR (tofacitinib) at two doses (5 mg twice a day and 10 mg twice a day) in patients with rheumatoid arthritis, who are at least 50 years of age and have at least one cardiovascular risk factor. Pfizer, the manufacturer of the drug, conducted the trial in multiple countries, including Canada.

The current Canadian label includes serious warnings and precautions for cancer and information on heart attacks, which were the most frequently reported serious heart-related problems in this trial.

Health Canada has not authorized the sale of the higher dose of 10 mg twice a day for rheumatoid arthritis or psoriatic arthritis; this dose is only authorized for patients with ulcerative colitis who have not responded well to other medications. For patients with ulcerative colitis, the Canadian prescribing information recommends that they use the lowest effective dose possible to lower the risk of adverse reactions.

Individuals currently taking Xeljanz should continue to do so, and should not stop or change their dosage of Xeljanz without speaking to their healthcare professional first.

 

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This recent safety alert from Health Canada echoes concerns voiced by the Food and Drug Administration (FDA) in early February 2021.  In this Drug Injury Watch article, "Xeljanz FDA Drug Safety Communication in February 2021 Puts Heightened Scrutiny on Pfizer", we covered the FDA's plans on how to address the Xeljanz safety concerns:

In early February 2021 the FDA doubled-down on these two Xeljanz safety issues: (1) Xeljanz causing heart problems; and (2) Xeljanz causing cancer. This FDA Drug Safety Communication, "Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)", provided the latest details about these "not-new" Xeljanz safety issues. And what I mean by this characterization is there was already a so-called Black Box Warning that points out reports of Xeljanz causing heart problems and Xeljanz causing cancer which was added to the Xeljanz drug label back in July 2019.

At that time, it was unclear what action the FDA was going to take regarding these concerns, and a February 4, 2021, MedPage Today news report, "No Xeljanz Plan Yet From FDA", reported the FDA was not yet prepared to take action.

Be assured that we will continue to follow this latest Xeljanz drug safety issue as well as watch for possible further FDA regulatory actions, including a possible Xeljanz recall.

 

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Long Term Elmiron Users Are At High Risk For Toxic Maculopathy

Nearly 20% Of Long Term Elmiron Users Diagnosed With Toxic Maculopathy

 

Written by: Lauren Schwab, Legal Assistant

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

 

A recent March 2021 article "Update on maculopathy secondary to pentosan polysulfate toxicity" for the Current Opinion in Ophthalmology medical journal shows a strong link between Elmiron, a drug typically used to treat interstitial cystitis (also known as painful bladder syndrome), and toxic maculopathy.  Maculopathy can lead to retinal changes and vision loss.

According to the Abstract for this article, nearly 20% of long-term Elmiron users have been diagnosed with Elmiron-related maculopathy. There is also strong evidence for a correlation between cumulative dosing for Elmiron and the likelihood or severity of the maculopathy:

Cross-sectional studies demonstrate evidence correlating cumulative dosing and the likelihood/severity of maculopathy. Early estimates of prevalence range from 12.7 to 41.7% depending on dosing, with overall rates around 20%.

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Covered in our most recent March 2021 blog post, "Onset of Maculopathy Due to Elmiron Possible Years After Patients Stopped Use of Elmiron", it is recommended established maculopathy patients be questioned regarding any Elmiron use in the past. The "Update on maculopathy secondary to pentosan polysulfate toxicity" corroborates this recommendation due to the high rate of maculopathy incidences in patients with previous Elmiron use:

Reasonable evidence associates maculopathy with extended exposure to PPS [Elmiron (pentosan polysulfate)], with an average reported incidence of around 20% in patients with long-term exposures. Patients with unexplained retinal pigment epithelium changes and difficulty with dark adaptation should be questioned regarding PPS [Elmiron (pentosan polysulfate)] exposure, and patients with known exposure to PPS [Elmiron (pentosan polysulfate)] should be examined. Further research is needed to refine screening protocols. Currently, providers should consider baseline examination and examination at 5 years and/or 500 g of exposure followed by yearly screening.

As we have reported previously on our Elmiron Information Page, as well as in our previous blog post, "Onset of Maculopathy Due to Elmiron Possible Years After Patients Stopped Use of Elmiron", 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, even potentially years, before a medical doctor was able to diagnose their eye problem.

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 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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Onset of Maculopathy Due to Elmiron Possible Years After Patients Stopped Use of Elmiron

New Medical Article About Elmiron-Related Vision Loss 3 Years After Elmiron Use

 

Written by: Lauren Schwab, Legal Assistant

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

 

A November 2020 article, "Potential new onset clinically detectable pentosan polysulfate maculopathy years after drug cessation", shows new research that further supports the idea that Elmiron-related vision loss can occur years after ending the use of Elmiron.

According to the Abstract for this recent article published by the Retinal Cases & Brief Reports medical journal, a 44-year-old female demonstrated signs of vision loss related to her Elmiron use which had ended nearly three years prior to her suspected diagnosis of maculopathy due to Elmiron:

A 44-year-old female with a 435g cumulative exposure to [Elmiron (pentosan polysulfate sodium)] presented 38-months after drug cessation with six months of worsening metamorphopsia and prolonged dark adaptation. Fundus exam and multimodal fundus imaging demonstrated characteristic features of [Elmiron (pentosan polysulfate)] maculopathy, and molecular testing was unremarkable. In contrast, color fundus photos of the same patient acquired at an outside facility 25 months prior did not display features consistent with [Elmiron (pentosan polysulfate)] maculopathy.

These findings are significant, as it shows the duration of time between the time a patient has stopped using Elmiron and the onset of Elmiron-related vision loss may be much longer than initially thought. 

Additionally, as we have reported previously in our January 2021 blog post, "Elmiron Maculopathy Secondary to Pentosan Polysulfate (PPS) Toxicity: Medical Journal Article", it had been suggested that established maculopathy patients should be questioned regarding any Elmiron use in the past.  This seems incredibly important now, as the onset of Elmiron-related vision loss may take place years after a patient has stopped using Elmiron.

 

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As we have reported previously on our Elmiron Information Page, 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, now potentially years, before a medical doctor was able to diagnose their eye problem.

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.

 

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