ELMIRON

Manufacturer 

 

Janssen Pharmaceuticals                           $372.04 Billion
Johnson & Johnson                                      https://www.janssen.com/us/
 
Bayer Pharmaceuticals
Teva Pharmaceuticals
Elmiron

 

 

FDA Approval 

 

Elmiron                                                            NDA 020193                         September 26, 1996
 
Generics                                                          None

 

 

MDL Information 

 

No information at this time

Background

In an article published in Urology in November 2018, Elmiron has experienced sales of over $150 million per year, despite limited efficacy. 
 
In a study, published in the Journal of Urology in March 2015, a randomized, double-blined, placebo controlled study found that, “There was no statistically significant difference between the pentosan polysulfate sodium group and the placebo group or between the 2 pentosan polysulfate sodium groups for the primary end point, defined as responder achieving a 30% or greater reduction from the baseline ICSI total score at study end.”   Janssen’s own website states, “it is not known exactly how Elmiron works”.
 
Used to treat interstitial cystitis, which is a chronic condition causing bladder pressure, bladder pain and sometimes pelvic pain.  IC is a common ailment among folks in the U.S. with more than 200,000 cases per year.  Women are up to 4 times more likely to suffer the condition than men, however, it is believed that the condition in men is underreported due to often being mistaken for another disorder, such as chronic prostatitis/chronic pelvic pain syndrome.
 
According to Navamedic.com: Elmiron had approximately 330,000 prescriptions and more than $250 million in annual U.S. sales (FY2016).

 

 

Treatment / Use

 
According to Janssen website, “ELMIRON® is a prescription medication used to treat the bladder pain or discomfort associated with interstitial cystitis (IC). It is not known exactly how ELMIRON® works, but it is not a pain medication like aspirin or acetaminophen and therefore must be taken continuously for relief as prescribed by your doctor.”
 
According to Drugs.com, Elmiron (sodium pentosan polysulfate) works like an anticoagulant (blood thinner) that prevents the formation of blood clots. However, it is used to treat bladder pain and discomfort caused by cystitis (bladder inflammation or irritation).
 
Interstitial Cystitis or Bladder Pain Syndrome (IC/BPS) affects an estimated 1.3 million Americans (2017).  Elmiron is the ONLY drug approved to treat IC/BPS.

Injuries / Complications / Concerns

 
In Spring 2018, Dr. Neiraj Jain and colleagues wrote a letter to the editor of the Journal of Urology to alert readers to a concerning new observation of vision threatening retinal changes associated with long-term exposure to PPS (pentosan polysulfate sodium).
 
 
The first clinical population based study found 24% of patients showed eye damage, and that the damage increased with the quantity of Elmiron taken.
 
 
The first national multicenter study showed no significant association at 5 years of use, but at 7 years, Elmiron users had significantly increased odds of having the atypical maculopathy outcome (OR=1.41, 95% CI 1.09 to 1.83, p=0.009).
 
 
Another study reported, “the present case adds a new layer of concern by demonstrating progressive maculopathy continuing for up to 6 years after the cessation of PPS (Elmiron).
 
 
Conditions or warning signs of maculopathy include: difficulty reading, taking a long time to adjust to the dark, difficulty seeing close objects, dimming vision, paracentral scotoma (a spot of vision loss in the field of vision).
 
In June 2020, Janssen changed the label to include “Retinal Pigmentary Changes”.
Other indicators include:
 
Hyperpigmented, dark spots on the retina that can be observed during an eye examination
 
Parafoveal pigmented deposits – vision loss may occur because of an abnormal effect on the capillaries and small blood vessels around the macula
 
Vitelliform deposits – these are round, somewhat yellow lesions under the macula, also known as adult pattern macular dystrophy
 
Retinal pigment epithelium atrophy – this is common with age-related macular degeneration

Information on the Topic of Elmiron

 

Elmiron Label in USA Now Includes New Warning about Eye Disease (6-17-2020)

https://www.ic-network.com/elmiron-label-has-been-changed-to-include-a-warning-about-eye-disease/

 

Elmiron Prescribing Information – Label Change (6-2020)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020193s014lbl.pdf

 

Long-Term Pentosan (Elmiron) Use May be Linked to Eye Disease (12-10-2019)

https://www.ic-network.com/long-term-pentosan-elmiron-use-may-be-linked-to-retinal-disease/

 

Researchers Raise Alarm about Eye Damage from Interstitial-Cystitis Drug

(10-23-2019)

https://www.uspharmacist.com/article/researchers-raise-alarm-about-eye-damage-from-interstitialcystitis-drug

 

New Study Adds Concern That Medication To Treat Painful Bladder Condition Linked To Vision-Threatening Eye Condition (10-17-2019)

https://www.forbes.com/sites/robertglatter/2019/10/17/new-study-adds-concern-that-medication-to-treat-painful-bladder-condition-linked-to-vision-threatening-eye-condition/#2ed3df961bf6

Bladder Drug can Cause Eye Damage: Study (10-15-2019)

https://www.usnews.com/news/health-news/articles/2019-10-15/bladder-drug-can-cause-eye-damage-study

 

More Evidence Linking Common Bladder Medication to a Vision-Threatening Eye Condition (10-12-2019)

https://www.sciencedaily.com/releases/2019/10/191012141218.htm

 

Government of Canada - Health Product InfoWatch (10-2019)

https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/health-product-infowatch/health-product-infowatch-october-2019.html#a3.2

 

Mayo Clinic – Interstitial Cystitis (9-14-2019)

https://www.mayoclinic.org/diseases-conditions/interstitial-cystitis/symptoms-causes/syc-20354357?utm_source=Google&utm_medium=abstract&utm_content=Interstitial-cystitis&utm_campaign=Knowledge-panel

Pigmentary Maculopathy From Chronic Exposure to Pentosan Polysulfate Sodium (12-7-2018)

https://www.aao.org/interview/pigmentary-maculopathy-from-chronic-exposure-to-pe

 

What is the Prevalence of Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS) in Women in the US? (11-14-2018)

https://www.medscape.com/answers/2055505-61934/what-is-the-prevalence-of-interstitial-cystitisbladder-pain-syndrome-icbps-in-women-in-the-us

 

2018 Top Stories in Urology: Severe Maculopathy Linked with Use of Soldium Pentosan Polysulfate (Elmiron) (11-12-2018)

https://www.practiceupdate.com/content/2018-top-stories-in-urology-severe-maculopathy-linked-with-use-of-sodium-pentosan-polysulfate/74882

 

Pigmentary Maculopathy Associated with Chronic Exposure to Pentosan Polysulfate Sodium (5-22-2018)

https://www.ncbi.nlm.nih.gov/pubmed/29801663

Diagnosing and Treating Interstitial Cystitis (5-1-2018)

https://www.health.harvard.edu/diseases-and-conditions/diagnosing-and-treating-interstitial-cystitis

 

Navamedic – Q3 Presentation (11-10-2017)

http://www.navamedic.com/globalassets/investor-relations/presentations/quaterly-presentations/nava_2017-q3_presentation_final2.pdf

 

Pentosan Polysulfate Sodium for Treatment of Interstitial Cystitis/Bladder Pain Syndrome: Insights from a Randomized, Double-Blind, Placebo Controlled Study

(3-1-2015)

https://www.auajournals.org/article/S0022-5347(14)04431-0/fulltext

 

In the U.S.: 4 to 12 Million may have Interstitial Cystitis (2-18-2015)

https://www.ichelp.org/about-ic/what-is-interstitial-cystitis/4-to-12-million-may-have-ic/

 

FDA Approval Package: Elmiron 020193 (12-12-2008)

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020193

 

FDA Prescribing Information: Elmiron 100mg (2008)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020193s009lbl.pdf