Pentosan polysulfate sodium, marketed under the brand name Elmiron, is used to treat bladder pain and discomfort associated with interstitial cystitis (IC).1 While its exact function is not clear,2 it may work by forming a layer on the bladder wall to protect it from harmful substances in the urine.3 The drug also functions as a blood thinner.4

Common side effects5 include:

• Hair loss
• Diarrhea
• Nausea
• Blood in the stool
• Headache
• Rash
• Upset stomach
• Abnormal liver function tests
• Dizziness
• Bruising
• Weight gain
• Swelling

Who is Prescribed Elmiron?

Elmiron is prescribed to patients who suffer from bladder pain or discomfort associated with IC. IC is a chronic condition that causes bladder pain, pressure, and sometimes pelvic pain.6 It is a part of the spectrum of diseases called painful bladder syndrome.7 IC disproportionately affects women.8 While there is no cure, medications like Elmiron and other therapies are used to treat the symptoms.9

New Side Effects

Various new possible side effects of Elmiron have emerged, particularly concerning eye damage.10 These side effects include dimming vision, difficulty with near vision, paracentral scotomas (vision loss), metamorphopsia (when straight lines become wavy), difficulty reading, and difficulty adapting to dim lighting.11 In at least one instance, eye damage has worsened even after discontinuing Elmiron.12

How the New Side Effects Came to Be Known

Researchers from the Emory Eye Center have noted several cases of retinal maculopathy (retinal injury) in IC patients who used Elmiron over an extended period of time.13

In May 2018, researchers published a case series documenting six women with IC presenting with pigmentary maculopathy, a condition affecting the center of the retina.14 What the patients had in common was extended use (a median of 186 months) of Elmiron.

Since the original study, other studies have confirmed the results and provided new insight. In May 2019, the Emory team studied ten more IC patients who developed macular disease after extended Elmiron use, noting structural changes to the retina.15 The team encouraged patients to discontinue use of Elmiron.16

In October 2019, a team at Kaiser Permanente noted a 24% rate of eye damage for IC patients who took Elmiron for longer than five years.17 The damage increased with the quantity of Elmiron taken.

Most recently, in November 2019, two studies were released. The first study, performed by the Emory team, showed an increased risk for Elmiron users of greater than seven years of having atypical maculopathy.18 Another study by the Harvest Medical School showed not only an association between Elmiron and eye damage, but also that eye damage may continue to worsen even after discontinuing Elmiron.19

If you or someone you know has suffered eye damage as a result of taking Elmiron, contact your Washington, DC defective drugs and medical devices lawyer. We offer free consultations to all new clients.

1 https://www.orthoelmiron.com

2 Id.

3 https://www.webmd.com/drugs/2/drug-14085/elmiron-oral/details

4 Id.

5 https://www.orthoelmiron.com

6 https://www.mayoclinic.org/diseases-conditions/interstitial-cystitis/symptoms-causes/syc-203543 57

7 Id.

8 Id.

9 Id.

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

11 Id.

12 Id.

13 Id.

14 Id.; see Pigmentary Maculopathy Associated with Chronic Exposure to Pentosan Polysulfate Sodium. Pearce WA, Chen R, Jain N. Ophthalmology. 2018 May 22.

15 Id.; see https://www.auajournals.org/doi/10.1097/01.JU.0000556315.46806.ca

16 Id.