Drug Safety Developments

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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Elmiron

Free Case Evaluation

Strictly Confidential, No Obligation.

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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.

 

Drug Injury Watch: Side Effects News & Reports

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Increased Risk of Myelodysplastic Syndrome and AML Associated with PARP Inhibitors

Alternative Options to PARP Inhibitors May Be Available

 

Written by: Lauren Schwab, Legal Assistant

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

 

Recent studies of Poly (ADP-ribose) polymerase, or PARP, inhibitors shows this class of drug may be linked to an increased risk of secondary myelodysplastic syndrome and acute myeloid leukemia (MDS/AML) in patients with cancer.

PARP inhibitors are used to treat several different types of cancers, including ovarian, breast, pancreatic, and prostate cancers.  PARP inhibitors work by stopping the PARP protein found in our cells from repairing the cells, essentially inhibiting cancer cells any further growth, and subsequently killing them off.

 

What The Studies Show

According to February 2021 article, "PARP inhibitors may increase risk for myelodysplastic syndrome, AML", recent studies show patients using PARP inhibitors are at nearly double the risk for developing MDS/AML compared to the placebo group:

According to results of the analysis, use of PARP inhibitors significantly increased risk for myelodysplastic syndrome and AML compared with placebo (OR = 2.63; 95% CI, 1.13-6.14).

The analysis of data from VigiBase showed 99 cases of myelodysplastic syndrome and 79 cases of AML associated with PARP inhibitor use.

Among 96 patients with available data, median treatment duration was 9.8 months (interquartile range [IQR], 3.6-17.4), and among 58 patients with available data, median latency period since first exposure to a PARP inhibitor was 17.8 months (IQR, 8.4-29.2). Researchers observed a high rate of mortality (45%) among 104 patients with reported outcomes. Cytopenia was co-reported in 71 (40%) of the 178 cases of myelodysplastic syndrome or AML, of which anemia was most frequent type (34%).

The study included PARP inhibitor drugs such as Lynparza (olaparib), Zejula (veliparib), Rubraca (rucaparib) and ABT-888 (veliparib).  Researchers acknowledge the number of MDS/AML incidences in correlation with PARP inhibitors may be underestimated in the study, and further research is needed to confirm the results.

 

PARP Inhibitors Not The Only Option for Cancer Treatment

Interestingly, PARP inhibitors are not the only class of drug available for treatment of cancer patients.  As we have reported in earlier articles, Vascular Endothelial Growth Factor (VEGF inhibitors) and immune checkpoint inhibitors have also been used "off-label" for treatment of cancer patients.

In our August 2020 article, "Vascular Endothelial Growth Factor (VEGF) Inhibitors: Increased Risk Of Aneurysm And Artery Dissection", we address the risks associated with VEGF inhibitors, such as aneurysm and artery dissection.  VEGF inhibitors include drugs such as Avastin (bevacizumab), Iclusig (ponatinib), Ofev (nintedanib), and many others.  You can find a more comprehensive list of VEGF inhibitors in our previously mentioned August 2020 article.

We will continue to monitor the safety profiles for these PARP inhibitors, including whether the FDA mandates any label changes which add warnings about an increased risk of MDS/AML.

 

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